Tooth LossNCT03659617
Healing Dynamics in Human Extraction Sockets Grafted With Bio-Oss Collagen®
A study testing xenograft (BioOss Collagen) in people with Tooth Loss, run by University of Iowa at 1 site in United States.
Trial summary
The purpose of this study is to clinically, radiographically and histologically evaluate the healing sequence of post-extraction sockets grafted with Bio-Oss Collagen® at 3, 6 and 9 months following tooth extraction in single-rooted tooth sites. Read more about this study
- Who is it for?
- Ages 18 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Loss
- What is being tested?
- xenograft (BioOss Collagen)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Dec 2018to 22 May 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- May be either male or female
- Age: 18 years or older
- Subjects with a single-rooted tooth (except mandibular incisors) indicated for extraction
- Extractions socket walls should either be intact or have no more than one bony wall (buccal or lingual) dehiscence extending no more than 50% of the total bony wall height
- Must be in adequate physical and mental health to undergo routine dental treatment including the surgical procedures associated tooth extraction and implant placement
- Subjects' treatment plan must include replacement of the tooth to be extracted with dental implant supported fixed restoration
- Subjects must have read, understood and signed an informed consent form
Who cannot join
- Mandibular incisors
- Acute infection associated with the tooth to be extracted or with adjacent teeth
- History of significant heart, stomach, liver, kidney, blood, immune system disease, or other organ impairment or systemic diseases that would prevent undergoing the proposed treatment or may result in compromised healing (e.g. poorly controlled diabetes, active heavy tobacco use [>10 cigs/day])
- Subjects with uncontrolled and/or severe metabolic bone diseases or disorders, such as osteoporosis, thyroid disorders or Paget's disease
- Subjects taking any medication or supplement known to largely influence bone metabolism, such as IV bisphosphonates, long-term history of oral bisphosphonates or chronic intake of glucocorticoids
- Pregnant women or nursing mothers
Show all 9Show fewer
- Subjects that are unwilling or unable to sign the informed consent
- History of lack of compliance with dental visits
- Subjects unwilling to return for the required number of visits
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Iowa College of Dentistry and Dental Clinics
Iowa City, Iowa, 52242
About this study
Official title: Clinical, Radiographic and Histomorphotmetric Analysis of Healing Dynamics in Human Extraction Sockets Grafted With Bio-Oss Collagen®: A Prospective 3-year Post-loading Study
The purpose of this study is to clinically, radiographically and histologically evaluate the healing sequence of post-extraction sockets grafted with Bio-Oss Collagen® at 3, 6 and 9 months following tooth extraction in single-rooted tooth sites.
Subjects with single rooted teeth planned for extraction and replacement with endosseous dental implants will be recruited for the study based on the eligibility criteria and will be divided in three groups (Groups 1, 2 and 3).A cone-beam computed tomography (CBCT) scan will be obtained and reviewed to prepare for the surgical approach and evaluate the ridge dimensions, the tooth planned for extraction as well as the adjacent sites. After tooth extraction, the socket will be grafted with Bio-Oss Collagen® and, depending on the morphology of the extraction sockets, a collagen matrix (Mucograft® seal) and/or a restorable collagen membrane (BioGide®)will be placed to cover and stabilize the graft. Patients will return at 2 and 6 weeks post-extraction to evaluate the healing. A second CBCT will be obtained 2 weeks prior to implant placement to evaluate the ridge dimensions and compare them to the baseline data. Implant placement will take place at 12, 24 and 36 after tooth extraction for Groups 1, 2 and 3 respectively. A bone core biopsy will be obtained at the time of implant placement and will be sent for histological analysis. Patients will return for a post-operative visit at two weeks. Clinical indices (probing depth, recession, bleeding upon probing, keratinized mucosa height, plaque and gingival index), patient reported outcomes and marginal bone levels via standardized periapical radiographs will be evaluated and recorded at baseline (no more than 30 days following delivery of final implant restoration) 1, 2 and 3 years post-loading.
Read the detailed description
Patients participating in this study are expected to return to the University of Iowa College of Dentistry for a total of 12 visits. The estimated study length per subject will vary between 42 to 48 months depending on group allocation.
VISIT 1: Screening Subjects in need of extraction of a single-rooted tooth, except for lower incisors, that meet all the inclusion and none of the exclusion criteria will be eligible to participate. The purpose of the study, the duration and the potential risks and benefits will be explained in detailed to the patients. If the subject is interested in participating in the study, copies of the study outline and consent forms will be given to them. Medical and dental history form will be entered in patients' charts electronically, completed and signed by the subjects. Intra-oral scan will be obtained (multiple photos that comprise a 3-D impression)
VISIT 2: Tooth Extraction (TE) and Ridge Preservation via Socket Grafting Medical and dental histories will be reviewed and possible changes will be recorded. Intra-oral photographs of the sites of interest will be obtained. Clinical and radiographic examination of the sites involved in the study will be performed. A cone-beam computed tomography (CBCT) scan will be obtained and reviewed to prepare for the surgical approach and evaluate the tooth planned for extraction as well as the adjacent sites for pathology and neighboring sensitive anatomic structures that can alter the proposed treatment plan. Digital intra-oral scanning of the area of interest will be performed using the Planmeca Emerald (TM) scanner. The subject will sign the surgical consent form. After administration of local anesthesia, the tooth will be extracted as less traumatically as possible, without flap reflection. Following tooth extraction, the socket walls will be clinically evaluated for the existence of dehiscences or fenestrations. Sites presenting a bony defect affecting >50% of the total wall height will be excluded. Sockets will be grafted with Bio-Oss Collagen®, BioGide® will be utilized if indicated for the treatment for a dehiscence and the coronal part will be covered with a collagen matrix (Mucograft Seal®). Stabilizing sutures will be applied to maintain the collagen matrix adequately in place. Written and verbal post-operative instructions will be given to the patients. They will be instructed to avoid any mechanical disturbance in the area for two weeks. Patients will be asked to use a mouthwash containing 0.12% of chlorhexidine gluconate twice a day, thirty seconds at a time, avoiding any eating or drinking for 30 minutes after rinsing, starting 48 hours after the baseline intervention. Post-operative medication (antibiotics, analgesics, NSAIDs) will be prescribed on an individual basis.
VISIT 3 (TE + 1 week) \& VISIT 4 (TE + 2 weeks): Postops Medical and dental histories will be reviewed and possible changes will be recorded. Intra-oral photographs and Intra-oral scan (multiple photos that comprise a 3-D impression) of the sites of interest will be obtained. Visual assessment of the healing status will be made using a WHI. Patients will be asked to report their pain using a Visual Analog Scale (VAS). Sutures will be removed at either of the two visits. Sites will be debrided, if necessary. and oral hygiene instructions will be reviewed.
VISIT 5: Post-op (TE + 6 weeks) Medical and dental histories will be reviewed and possible changes will be recorded. Intra-oral photographs and Intra-oral scan will be obtained (multiple photos that comprise a 3-D impression) of the sites of interest will be obtained. Visual assessment of the healing status will be made using a WHI. Patients will be asked to report their pain using a VAS. Gentle plaque debridement will be provided and oral hygiene instructions will be reviewed.
VISIT 6: Follow-up and second CBCT scan Group 1 (TE + 10 weeks) Group 2 (TE + 22 weeks) Group 3 (TE + 34 weeks) Medical and dental histories will be reviewed and updated, if necessary. Intra-oral pictures of the surgical sites will be obtained. At this visit, a second segmental CBCT scan will be obtained for all patients, using the same settings employed at baseline. Images will be used to analyze and compare the ridge dimensions to those obtained at baseline as well as in terms of adequacy for dental implant placement. Intra-oral scan will be obtained (multiple photos that comprise a 3-D impression).
VISIT 7: Implant Placement and Bone Core Biopsy Harvesting Group 1 (TE + 12 weeks) Group 2 (TE + 24 weeks) Group 3 (TE + 36 weeks) Medical and dental histories will be reviewed and possible changes will be recorded. Intra-oral photographs of the sites of interest will be obtained. Digital intra-oral scanning of the area of interest will be performed using the Planmeca Emerald (TM) scanner. Implant placement will be done per standard procedure. A trephine drill of 2.5 mm diameter, or wider, will be used to harvest a bone core for histologic and µ-CT analyses. The bone core will be immediately submerged in a solution of 10% neutral buffered formalin (NBF). The selection of the implant system and dimensions will depend on the surgical and restorative needs of each individual case. Osteotomies and implant placement will be done following the manufacturer's recommendations. A final periapical radiograph will be obtained to verify correct implant position and angulation. Depending on the buccal bone and soft tissue thickness, ancillary soft tissue augmentation, bone augmentation or a combination of both may be indicated. If adequate primary stability is achieved and a one-stage approach is feasible, a healing abutment will be placed. If a two-stage procedure is indicated, a cover screw will be placed and the implant will be submerged. At the end of the appointment, written and verbal post-operative instructions will be given to the patients.
VISIT 8: Post-op (Implant Placement + 2 weeks) Medical and dental histories will be reviewed and possible changes will be recorded. Intra-oral photographs of the sites of interest will be obtained. Sutures will be removed. Visual assessment of the healing status will be made using a WHI. Patients will be asked to report their pain using a VAS. The sites will be debrided and oral hygiene instructions will be reviewed. Upon completion of this visit, the patient will be referred to the restorative dentist to complete the restorative part of the treatment.
VISIT 9: Baseline Implant Follow-up (No more than 30 days after delivery of final restoration) Medical and dental histories will be reviewed and possible changes will be recorded. Intra-oral photographs of the sites of interest will be obtained. Digital intra-oral scanning of the area of interest will be performed using the Planmeca Emerald (TM) scanner. Patients will be asked to report their level of satisfaction in terms of function, comfort and esthetics (PROMs). The sites will be inspected, deplaqued, if necessary, and oral hygiene instructions will be reviewed. Clinical parameters will be recorded (i.e. probing depth, recession respective to the incisal/occlusal plane, bleeding upon probing, keratinized mucosa height, plaque and gingival index). A standardized periapical radiograph will be obtained to assess marginal bone levels.
VISIT 10: Implant Follow-up #1 (1 year after delivery of final restoration) Medical and dental histories will be reviewed and possible changes will be recorded. Intra-oral photographs of the sites of interest will be obtained. Digital intra-oral scanning of the area of interest will be performed using the Planmeca Emerald (TM) scanner. Patients will be asked to report their level of satisfaction in terms of function, comfort and esthetics (PROMs). The sites will be inspected, de-plaqued, if necessary, and oral hygiene instructions will be reviewed. Clinical parameters will be recorded (i.e. probing depth, recession respective to the incisal/occlusal plane, bleeding upon probing, keratinized mucosa height, plaque and gingival index). A standardized periapical radiograph will be obtained to assess marginal bone levels.
VISIT 11: Implant Follow-up #2 (2 years after delivery of final restoration) Medical and dental histories will be reviewed and possible changes will be recorded. Intra-oral photographs of the sites of interest will be obtained. Digital intra-oral scanning of the area of interest will be performed using the Planmeca Emerald (TM) scanner. Patients will be asked to report their level of satisfaction in terms of function, comfort and esthetics (PROMs). The sites will be inspected, de-plaqued, if necessary, and oral hygiene instructions will be reviewed. Clinical parameters will be recorded (i.e. probing depth, recession respective to the incisal/occlusal plane, bleeding upon probing, keratinized mucosa height, plaque and gingival index). A standardized periapical radiograph will be obtained to assess marginal bone levels.
VISIT 12: Implant Follow-up #3 (3 years after delivery of final restoration) Medical and dental histories will be reviewed and possible changes will be recorded. Intra-oral photographs of the sites of interest will be obtained. Digital intra-oral scanning of the area of interest will be performed using the Planmeca Emerald (TM) scanner. Patients will be asked to report their level of satisfaction in terms of function, comfort and esthetics (PROMs). The sites will be inspected, de-plaqued, if necessary, and oral hygiene instructions will be reviewed. Clinical parameters will be recorded (i.e. probing depth, recession respective to the incisal/occlusal plane, bleeding upon probing, keratinized mucosa height, plaque and gingival index). A standardized periapical radiograph will be obtained to assess marginal bone levels.
This is planned to be the final study visit.
- Conditions
- Tooth Loss
- Being tested
- xenograft (BioOss Collagen)
- Keywords
- alveolar bone, alveolar ridge, bone resorption, bone grafting, barrier membrane
- Medical subject headings
- Tooth Loss, Bone Resorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
xenograft (BioOss Collagen)Device
Alveolar ridge preservation using xenograft (BioOss Collagen) and implant placement at specified interval.
| Study group | Role | What they receive |
|---|---|---|
| Implant placement 3 mo. after tooth ext. | Experimental | Alveolar ridge preservation using xenograft (BioOss Collagen) and Implant placement 3 mo. after tooth ext. Receives: Device: xenograft (BioOss Collagen) |
| Implant placement 6 mo. after tooth ext. | Active comparator | Alveolar ridge preservation using xenograft (BioOss Collagen) and Implant placement 6 mo. after tooth ext. Receives: Device: xenograft (BioOss Collagen) |
| Implant placement 9 mo. after tooth ext. | Active comparator | Alveolar ridge preservation using xenograft (BioOss Collagen) and Implant placement 9 mo. after tooth ext. Receives: Device: xenograft (BioOss Collagen) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants That Had an Implant That Survived 3 Years After Implant Placement
For participants that had implant placement, this outcome is determined via clinical evaluation of the number of participants that still had their 1 implant in place after 3 Years. Note: Only 1 implant was placed per participant.
Measured: 3 years after implant placement
Secondary outcomes (13)
Median Percentage of Mineralized Tissue (Vital Bone)
After histological staining, median percent of mineralized tissue (vital bone) was calculated by appearance using ImageJ (NIH, open-source software).
Measured: 3 months, 6 months, 9 months
Median Percentage of Non-mineralized Tissue
Median percentage of non-mineralized tissue: Following histological staining, the percentage of non-mineralized tissue was calculated using ImageJ (NIH, open-source software). The total tissue area was measured, and the percentages of mineralized tissue and residual xenograft material were subtracted from the total area. The remaining area was reported as the percentage of non-mineralized tissue.
Measured: 3 months, 6 months, 9 months
Median Change in Bone Width Reduction (at 1, 3, 5mm Apical to Bone Crest) From Final Follow-up to Baseline for Each Group
When compared to baseline, determine if there is a change in median bone width reduction (at 1, 3, 5mm apical to bone crest) for each group (implant placement 3 months after tooth extraction, implant placement 6 months after tooth extraction, implant placement 9 months after tooth extraction), which will be measured using clinical and radiographic (via CBCT) assessment. To calculate change, the final follow-up value for each group is subtracted from the baseline value.
Measured: Baseline, Final Follow-Up (4 weeks before implant placement)
Assessment of the Mucosal Maturation of the Extraction Sites After the Use of Mucograft Seal® at 1 Week, Using a Wound Healing Index (1-3 Scale Rating)
Wound Healing Index. 1-3 scale rating: 1) Uneventful Healing, 2) Normal healing with moderate soft tissue inflammation, erythema but no suppuration and 3) poor wound healing with significant signs of clinical inflammation and/or suppuration
Measured: 1 week following tooth extraction and alveolar ridge preservation
Assessment of the Mucosal Maturation of the Extraction Sites After the Use of Mucograft Seal® @ 2 Weeks, Using a Wound Healing Index (1-3 Scale Rating)
Wound Healing Index.1-3 scale rating: 1) Uneventful Healing, 2) Normal healing with moderate soft tissue inflammation, erythema but no suppuration and 3) poor wound healing with significant signs of clinical inflammation and/or suppuration
Measured: 2 weeks following tooth extraction and alveolar ridge preservation
Assessment of the Mucosal Maturation of the Extraction Sites After the Use of Mucograft Seal® at 6 Weeks, Using a Wound Healing Index (1-3 Scale Rating)
Wound Healing Index. 1-3 scale rating: 1) Uneventful Healing, 2) Normal healing with moderate soft tissue inflammation, erythema but no suppuration and 3) poor wound healing with significant signs of clinical inflammation and/or suppuration
Measured: 6 weeks following tooth extraction and alveolar ridge preservation
Assessment of the Mucosal Maturation Following Implant Placement, Using a Wound Healing Index (1-3 Scale Rating)
Wound Healing Index. 1-3 scale rating: 1) Uneventful Healing, 2) Normal healing with moderate soft tissue inflammation, erythema but no suppuration and 3) poor wound healing with significant signs of clinical inflammation and/or suppuration
Measured: 2 weeks following dental implant placement
Patient Reported Outcomes (Pain) 1 Week Following Tooth Extraction, Using a Visual Analog Score for Pain (0-100)
Visual Analog Score for pain (0-100, with 0 representing no pain, and 100 very severe pain, described as "worse pain imaginable").
Measured: 1 week following tooth extraction and alveolar ridge preservation
Patient Reported Outcomes (Pain) 2 Weeks Following Tooth Extraction, Using a Visual Analog Score for Pain (0-100)
Visual Analog Score for pain (0-100, with 0 representing no pain, and 100 very severe pain, described as "worse pain imaginable").
Measured: 2 weeks following tooth extraction and alveolar ridge preservation
Patient Reported Outcomes (Pain) 6 Weeks Following Tooth Extraction, Using a Visual Analog Score for Pain (0-100)
Visual Analog Score for pain (0-100, with 0 representing no pain, and 100 very severe pain, described as "worse pain imaginable").
Measured: 6 weeks following tooth extraction and alveolar ridge preservation
Patient Reported Outcomes (Pain) 2 Weeks Following Implant Placement, Using a Visual Analog Score for Pain (0-100)
Visual Analog Score for pain (0-100, with 0 representing no pain, and 100 very severe pain, described as "worse pain imaginable").
Measured: 2 weeks following implant placement
Patient Reported Outcomes (Patient Satisfaction), Using a Visual Analog Scale (0-100)
The patients will be asked to rate their satisfaction in terms of function using a Visual Analog Scale (0-100, with 0 meaning "not at satisfied at all" and 100 corresponding to "perfectly satisfied").
Measured: Up to 30 days post implant crown delivery
Change in Marginal Bone Level From Crown Placement to 3 Years After Crown Placement.
Measured in millimeters based on standardized intra-oral radiographs at crown placement and 3 years after crown placement. Negative values depicts bone levels below fixpoint (implant platform) meaning "true" bone loss. Positive values denotes bone levels above fixpoint meaning minimum remodeling following implant placement.
Measured: Implant Crown Delivery, 3 years post implant crown delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2018
- Study start10 Dec 2018
- Primary completion22 May 2025
- Study completion22 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (46)Papers the sponsor has linked to this study.
- Other trials for Tooth LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Collaborators
- Geistlich Pharma AG
- Responsible party
- Principal investigator, Carlos Garaicoa Pazmino, University of Iowa
- Investigators
- Carlos Garaicoa Pazmino, DDS, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03659617
- Sponsor's protocol ID
- 201806050
- Status last verified
- Aug 2026
- First submitted
- 10 Jul 2018
- Last updated
- 3 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Abrams L. Augmentation of the deformed residual edentulous ridge for fixed prosthesis. Compend Contin Educ Gen Dent. 1980 May-Jun;1(3):205-13. No abstract available.
PubMed 6950834Aghaloo TL, Misch C, Lin GH, Iacono VJ, Wang HL. Bone Augmentation of the Edentulous Maxilla for Implant Placement: A Systematic Review. Int J Oral Maxillofac Implants. 2016;31 Suppl:s19-30. doi: 10.11607/jomi.16suppl.g1.
PubMed 27228250Aghaloo TL, Moy PK. Which hard tissue augmentation techniques are the most successful in furnishing bony support for implant placement? Int J Oral Maxillofac Implants. 2007;22 Suppl:49-70.
PubMed 18437791Alkan EA, Parlar A, Yildirim B, Senguven B. Histological comparison of healing following tooth extraction with ridge preservation using enamel matrix derivatives versus Bio-Oss Collagen: a pilot study. Int J Oral Maxillofac Surg. 2013 Dec;42(12):1522-8. doi: 10.1016/j.ijom.2013.06.002. Epub 2013 Jul 8.
PubMed 23845297Amler MH. The time sequence of tissue regeneration in human extraction wounds. Oral Surg Oral Med Oral Pathol. 1969 Mar;27(3):309-18. doi: 10.1016/0030-4220(69)90357-0. No abstract available.
PubMed 5251474Araujo M, Linder E, Wennstrom J, Lindhe J. The influence of Bio-Oss Collagen on healing of an extraction socket: an experimental study in the dog. Int J Periodontics Restorative Dent. 2008 Apr;28(2):123-35.
PubMed 18546808Araujo MG, da Silva JCC, de Mendonca AF, Lindhe J. Ridge alterations following grafting of fresh extraction sockets in man. A randomized clinical trial. Clin Oral Implants Res. 2015 Apr;26(4):407-412. doi: 10.1111/clr.12366. Epub 2014 Mar 12.
PubMed 24621203Araujo MG, Liljenberg B, Lindhe J. Dynamics of Bio-Oss Collagen incorporation in fresh extraction wounds: an experimental study in the dog. Clin Oral Implants Res. 2010 Jan;21(1):55-64. doi: 10.1111/j.1600-0501.2009.01854.x.
PubMed 20070748Araujo MG, Lindhe J. Dimensional ridge alterations following tooth extraction. An experimental study in the dog. J Clin Periodontol. 2005 Feb;32(2):212-8. doi: 10.1111/j.1600-051X.2005.00642.x.
PubMed 15691354Avila-Ortiz G, Elangovan S, Kramer KW, Blanchette D, Dawson DV. Effect of alveolar ridge preservation after tooth extraction: a systematic review and meta-analysis. J Dent Res. 2014 Oct;93(10):950-8. doi: 10.1177/0022034514541127. Epub 2014 Jun 25.
PubMed 24966231Barone A, Aldini NN, Fini M, Giardino R, Calvo Guirado JL, Covani U. Xenograft versus extraction alone for ridge preservation after tooth removal: a clinical and histomorphometric study. J Periodontol. 2008 Aug;79(8):1370-7. doi: 10.1902/jop.2008.070628.
PubMed 18672985Beitlitum I, Artzi Z, Nemcovsky CE. Clinical evaluation of particulate allogeneic with and without autogenous bone grafts and resorbable collagen membranes for bone augmentation of atrophic alveolar ridges. Clin Oral Implants Res. 2010 Nov;21(11):1242-50. doi: 10.1111/j.1600-0501.2010.01936.x.
PubMed 20572833Boyne PJ. Osseous repair of the postextraction alveolus in man. Oral Surg Oral Med Oral Pathol. 1966 Jun;21(6):805-13. doi: 10.1016/0030-4220(66)90104-6. No abstract available.
PubMed 5219671Canullo L, Iurlaro G, Iannello G. Double-blind randomized controlled trial study on post-extraction immediately restored implants using the switching platform concept: soft tissue response. Preliminary report. Clin Oral Implants Res. 2009 Apr;20(4):414-20. doi: 10.1111/j.1600-0501.2008.01660.x.
PubMed 19298296Cardaropoli D, Tamagnone L, Roffredo A, Gaveglio L. Evaluation of Dental Implants Placed in Preserved and Nonpreserved Postextraction Ridges: A 12-Month Postloading Study. Int J Periodontics Restorative Dent. 2015 Sep-Oct;35(5):677-85. doi: 10.11607/prd.2309.
PubMed 26357697
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, Radiographic and Histomorphotmetric Analysis of Healing Dynamics in Human Extraction Sockets Grafted With Bio-Oss Collagen®: A Prospective 3-year Post-loading Study
- ClinicalTrials.gov ID
- NCT03659617
- Acronym / sponsor ID
- 201806050
- Conditions
- Tooth Loss
- Keywords
- alveolar bone, alveolar ridge, bone resorption, bone grafting, barrier membrane
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Collaborators
- Geistlich Pharma AG
- Study start
- 10 Dec 2018 (actual)
- Primary completion
- 22 May 2025 (actual)
- Study completion
- 22 May 2025 (actual)
- First posted
- 6 Sep 2018 (actual)
- Results
- Posted 9 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to clinically, radiographically and histologically evaluate the healing sequence of post-extraction sockets grafted with Bio-Oss Collagen® at 3, 6 and 9 months following tooth extraction in single-rooted tooth sites.
Subjects with single rooted teeth planned for extraction and replacement with endosseous dental implants will be recruited for the study based on the eligibility criteria and will be divided in three groups (Groups 1, 2 and 3).A cone-beam computed tomography (CBCT) scan will be obtained and reviewed to prepare for the surgical approach and evaluate the ridge dimensions, the tooth planned for extraction as well as the adjacent sites. After tooth extraction, the socket will be grafted with Bio-Oss Collagen® and, depending on the morphology of the extraction sockets, a collagen matrix (Mucograft® seal) and/or a restorable collagen membrane (BioGide®)will be placed to cover and stabilize the graft. Patients will return at 2 and 6 weeks post-extraction to evaluate the healing. A second CBCT will be obtained 2 weeks prior to implant placement to evaluate the ridge dimensions and compare them to the baseline data. Implant placement will take place at 12, 24 and 36 after tooth extraction for Groups 1, 2 and 3 respectively. A bone core biopsy will be obtained at the time of implant placement and will be sent for histological analysis. Patients will return for a post-operative visit at two weeks. Clinical indices (probing depth, recession, bleeding upon probing, keratinized mucosa height, plaque and gingival index), patient reported outcomes and marginal bone levels via standardized periapical radiographs will be evaluated and recorded at baseline (no more than 30 days following delivery of final implant restoration) 1, 2 and 3 years post-loading.
Detailed description
Patients participating in this study are expected to return to the University of Iowa College of Dentistry for a total of 12 visits. The estimated study length per subject will vary between 42 to 48 months depending on group allocation.
VISIT 1: Screening Subjects in need of extraction of a single-rooted tooth, except for lower incisors, that meet all the inclusion and none of the exclusion criteria will be eligible to participate. The purpose of the study, the duration and the potential risks and benefits will be explained in detailed to the patients. If the subject is interested in participating in the study, copies of the study outline and consent forms will be given to them. Medical and dental history form will be entered in patients' charts electronically, completed and signed by the subjects. Intra-oral scan will be obtained (multiple photos that comprise a 3-D impression)
VISIT 2: Tooth Extraction (TE) and Ridge Preservation via Socket Grafting Medical and dental histories will be reviewed and possible changes will be recorded. Intra-oral photographs of the sites of interest will be obtained. Clinical and radiographic examination of the sites involved in the study will be performed. A cone-beam computed tomography (CBCT) scan will be obtained and reviewed to prepare for the surgical approach and evaluate the tooth planned for extraction as well as the adjacent sites for pathology and neighboring sensitive anatomic structures that can alter the proposed treatment plan. Digital intra-oral scanning of the area of interest will be performed using the Planmeca Emerald (TM) scanner. The subject will sign the surgical consent form. After administration of local anesthesia, the tooth will be extracted as less traumatically as possible, without flap reflection. Following tooth extraction, the socket walls will be clinically evaluated for the existence of dehiscences or fenestrations. Sites presenting a bony defect affecting >50% of the total wall height will be excluded. Sockets will be grafted with Bio-Oss Collagen®, BioGide® will be utilized if indicated for the treatment for a dehiscence and the coronal part will be covered with a collagen matrix (Mucograft Seal®). Stabilizing sutures will be applied to maintain the collagen matrix adequately in place. Written and verbal post-operative instructions will be given to the patients. They will be instructed to avoid any mechanical disturbance in the area for two weeks. Patients will be asked to use a mouthwash containing 0.12% of chlorhexidine gluconate twice a day, thirty seconds at a time, avoiding any eating or drinking for 30 minutes after rinsing, starting 48 hours after the baseline intervention. Post-operative medication (antibiotics, analgesics, NSAIDs) will be prescribed on an individual basis.
VISIT 3 (TE + 1 week) \& VISIT 4 (TE + 2 weeks): Postops Medical and dental histories will be reviewed and possible changes will be recorded. Intra-oral photographs and Intra-oral scan (multiple photos that comprise a 3-D impression) of the sites of interest will be obtained. Visual assessment of the healing status will be made using a WHI. Patients will be asked to report their pain using a Visual Analog Scale (VAS). Sutures will be removed at either of the two visits. Sites will be debrided, if necessary. and oral hygiene instructions will be reviewed.
VISIT 5: Post-op (TE + 6 weeks) Medical and dental histories will be reviewed and possible changes will be recorded. Intra-oral photographs and Intra-oral scan will be obtained (multiple photos that comprise a 3-D impression) of the sites of interest will be obtained. Visual assessment of the healing status will be made using a WHI. Patients will be asked to report their pain using a VAS. Gentle plaque debridement will be provided and oral hygiene instructions will be reviewed.
VISIT 6: Follow-up and second CBCT scan Group 1 (TE + 10 weeks) Group 2 (TE + 22 weeks) Group 3 (TE + 34 weeks) Medical and dental histories will be reviewed and updated, if necessary. Intra-oral pictures of the surgical sites will be obtained. At this visit, a second segmental CBCT scan will be obtained for all patients, using the same settings employed at baseline. Images will be used to analyze and compare the ridge dimensions to those obtained at baseline as well as in terms of adequacy for dental implant placement. Intra-oral scan will be obtained (multiple photos that comprise a 3-D impression).
VISIT 7: Implant Placement and Bone Core Biopsy Harvesting Group 1 (TE + 12 weeks) Group 2 (TE + 24 weeks) Group 3 (TE + 36 weeks) Medical and dental histories will be reviewed and possible changes will be recorded. Intra-oral photographs of the sites of interest will be obtained. Digital intra-oral scanning of the area of interest will be performed using the Planmeca Emerald (TM) scanner. Implant placement will be done per standard procedure. A trephine drill of 2.5 mm diameter, or wider, will be used to harvest a bone core for histologic and µ-CT analyses. The bone core will be immediately submerged in a solution of 10% neutral buffered formalin (NBF). The selection of the implant system and dimensions will depend on the surgical and restorative needs of each individual case. Osteotomies and implant placement will be done following the manufacturer's recommendations. A final periapical radiograph will be obtained to verify correct implant position and angulation. Depending on the buccal bone and soft tissue thickness, ancillary soft tissue augmentation, bone augmentation or a combination of both may be indicated. If adequate primary stability is achieved and a one-stage approach is feasible, a healing abutment will be placed. If a two-stage procedure is indicated, a cover screw will be placed and the implant will be submerged. At the end of the appointment, written and verbal post-operative instructions will be given to the patients.
VISIT 8: Post-op (Implant Placement + 2 weeks) Medical and dental histories will be reviewed and possible changes will be recorded. Intra-oral photographs of the sites of interest will be obtained. Sutures will be removed. Visual assessment of the healing status will be made using a WHI. Patients will be asked to report their pain using a VAS. The sites will be debrided and oral hygiene instructions will be reviewed. Upon completion of this visit, the patient will be referred to the restorative dentist to complete the restorative part of the treatment.
VISIT 9: Baseline Implant Follow-up (No more than 30 days after delivery of final restoration) Medical and dental histories will be reviewed and possible changes will be recorded. Intra-oral photographs of the sites of interest will be obtained. Digital intra-oral scanning of the area of interest will be performed using the Planmeca Emerald (TM) scanner. Patients will be asked to report their level of satisfaction in terms of function, comfort and esthetics (PROMs). The sites will be inspected, deplaqued, if necessary, and oral hygiene instructions will be reviewed. Clinical parameters will be recorded (i.e. probing depth, recession respective to the incisal/occlusal plane, bleeding upon probing, keratinized mucosa height, plaque and gingival index). A standardized periapical radiograph will be obtained to assess marginal bone levels.
VISIT 10: Implant Follow-up #1 (1 year after delivery of final restoration) Medical and dental histories will be reviewed and possible changes will be recorded. Intra-oral photographs of the sites of interest will be obtained. Digital intra-oral scanning of the area of interest will be performed using the Planmeca Emerald (TM) scanner. Patients will be asked to report their level of satisfaction in terms of function, comfort and esthetics (PROMs). The sites will be inspected, de-plaqued, if necessary, and oral hygiene instructions will be reviewed. Clinical parameters will be recorded (i.e. probing depth, recession respective to the incisal/occlusal plane, bleeding upon probing, keratinized mucosa height, plaque and gingival index). A standardized periapical radiograph will be obtained to assess marginal bone levels.
VISIT 11: Implant Follow-up #2 (2 years after delivery of final restoration) Medical and dental histories will be reviewed and possible changes will be recorded. Intra-oral photographs of the sites of interest will be obtained. Digital intra-oral scanning of the area of interest will be performed using the Planmeca Emerald (TM) scanner. Patients will be asked to report their level of satisfaction in terms of function, comfort and esthetics (PROMs). The sites will be inspected, de-plaqued, if necessary, and oral hygiene instructions will be reviewed. Clinical parameters will be recorded (i.e. probing depth, recession respective to the incisal/occlusal plane, bleeding upon probing, keratinized mucosa height, plaque and gingival index). A standardized periapical radiograph will be obtained to assess marginal bone levels.
VISIT 12: Implant Follow-up #3 (3 years after delivery of final restoration) Medical and dental histories will be reviewed and possible changes will be recorded. Intra-oral photographs of the sites of interest will be obtained. Digital intra-oral scanning of the area of interest will be performed using the Planmeca Emerald (TM) scanner. Patients will be asked to report their level of satisfaction in terms of function, comfort and esthetics (PROMs). The sites will be inspected, de-plaqued, if necessary, and oral hygiene instructions will be reviewed. Clinical parameters will be recorded (i.e. probing depth, recession respective to the incisal/occlusal plane, bleeding upon probing, keratinized mucosa height, plaque and gingival index). A standardized periapical radiograph will be obtained to assess marginal bone levels.
This is planned to be the final study visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Implant placement 3 mo. after tooth ext. | Experimental | Device: xenograft (BioOss Collagen)Alveolar ridge preservation using xenograft (BioOss Collagen) and Implant placement 3 mo. after tooth ext. |
| Implant placement 6 mo. after tooth ext. | Active comparator | Device: xenograft (BioOss Collagen)Alveolar ridge preservation using xenograft (BioOss Collagen) and Implant placement 6 mo. after tooth ext. |
| Implant placement 9 mo. after tooth ext. | Active comparator | Device: xenograft (BioOss Collagen)Alveolar ridge preservation using xenograft (BioOss Collagen) and Implant placement 9 mo. after tooth ext. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- May be either male or female
- Age: 18 years or older
- Subjects with a single-rooted tooth (except mandibular incisors) indicated for extraction
- Extractions socket walls should either be intact or have no more than one bony wall (buccal or lingual) dehiscence extending no more than 50% of the total bony wall height
- Must be in adequate physical and mental health to undergo routine dental treatment including the surgical procedures associated tooth extraction and implant placement
Key exclusion criteria (9 listed)
- Mandibular incisors
- Acute infection associated with the tooth to be extracted or with adjacent teeth
- History of significant heart, stomach, liver, kidney, blood, immune system disease, or other organ impairment or systemic diseases that would prevent undergoing the proposed treatment or may result in compromised healing (e.g. poorly controlled diabetes, active heavy tobacco use [>10 cigs/day])
- Subjects with uncontrolled and/or severe metabolic bone diseases or disorders, such as osteoporosis, thyroid disorders or Paget's disease
- Subjects taking any medication or supplement known to largely influence bone metabolism, such as IV bisphosphonates, long-term history of oral bisphosphonates or chronic intake of glucocorticoids
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| xenograft (BioOss Collagen)Alveolar ridge preservation using xenograft (BioOss Collagen) and implant placement at specified interval. | Device | Implant placement 3 mo. after tooth ext., Implant placement 6 mo. after tooth ext., Implant placement 9 mo. after tooth ext. |
Primary outcome
Number of Participants That Had an Implant That Survived 3 Years After Implant Placement
Time frame: 3 years after implant placement
For participants that had implant placement, this outcome is determined via clinical evaluation of the number of participants that still had their 1 implant in place after 3 Years. Note: Only 1 implant was placed per participant.
13 secondary outcomes
Median Percentage of Mineralized Tissue (Vital Bone)
Time frame: 3 months, 6 months, 9 months
Median Percentage of Non-mineralized Tissue
Time frame: 3 months, 6 months, 9 months
Median Change in Bone Width Reduction (at 1, 3, 5mm Apical to Bone Crest) From Final Follow-up to Baseline for Each Group
Time frame: Baseline, Final Follow-Up (4 weeks before implant placement)
Assessment of the Mucosal Maturation of the Extraction Sites After the Use of Mucograft Seal® at 1 Week, Using a Wound Healing Index (1-3 Scale Rating)
Time frame: 1 week following tooth extraction and alveolar ridge preservation
Assessment of the Mucosal Maturation of the Extraction Sites After the Use of Mucograft Seal® @ 2 Weeks, Using a Wound Healing Index (1-3 Scale Rating)
Time frame: 2 weeks following tooth extraction and alveolar ridge preservation
Assessment of the Mucosal Maturation of the Extraction Sites After the Use of Mucograft Seal® at 6 Weeks, Using a Wound Healing Index (1-3 Scale Rating)
Time frame: 6 weeks following tooth extraction and alveolar ridge preservation
Assessment of the Mucosal Maturation Following Implant Placement, Using a Wound Healing Index (1-3 Scale Rating)
Time frame: 2 weeks following dental implant placement
Patient Reported Outcomes (Pain) 1 Week Following Tooth Extraction, Using a Visual Analog Score for Pain (0-100)
Time frame: 1 week following tooth extraction and alveolar ridge preservation
Patient Reported Outcomes (Pain) 2 Weeks Following Tooth Extraction, Using a Visual Analog Score for Pain (0-100)
Time frame: 2 weeks following tooth extraction and alveolar ridge preservation
Patient Reported Outcomes (Pain) 6 Weeks Following Tooth Extraction, Using a Visual Analog Score for Pain (0-100)
Time frame: 6 weeks following tooth extraction and alveolar ridge preservation
Patient Reported Outcomes (Pain) 2 Weeks Following Implant Placement, Using a Visual Analog Score for Pain (0-100)
Time frame: 2 weeks following implant placement
Patient Reported Outcomes (Patient Satisfaction), Using a Visual Analog Scale (0-100)
Time frame: Up to 30 days post implant crown delivery
Change in Marginal Bone Level From Crown Placement to 3 Years After Crown Placement.
Time frame: Implant Crown Delivery, 3 years post implant crown delivery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 6950834Abrams L. Augmentation of the deformed residual edentulous ridge for fixed prosthesis. Compend Contin Educ Gen Dent. 1980 May-Jun;1(3):205-13. No abstract available.
- Background: PubMed 27228250Aghaloo TL, Misch C, Lin GH, Iacono VJ, Wang HL. Bone Augmentation of the Edentulous Maxilla for Implant Placement: A Systematic Review. Int J Oral Maxillofac Implants. 2016;31 Suppl:s19-30. doi: 10.11607/jomi.16suppl.g1.
- Background: PubMed 18437791Aghaloo TL, Moy PK. Which hard tissue augmentation techniques are the most successful in furnishing bony support for implant placement? Int J Oral Maxillofac Implants. 2007;22 Suppl:49-70.
- Background: PubMed 23845297Alkan EA, Parlar A, Yildirim B, Senguven B. Histological comparison of healing following tooth extraction with ridge preservation using enamel matrix derivatives versus Bio-Oss Collagen: a pilot study. Int J Oral Maxillofac Surg. 2013 Dec;42(12):1522-8. doi: 10.1016/j.ijom.2013.06.002. Epub 2013 Jul 8.
- Background: PubMed 5251474Amler MH. The time sequence of tissue regeneration in human extraction wounds. Oral Surg Oral Med Oral Pathol. 1969 Mar;27(3):309-18. doi: 10.1016/0030-4220(69)90357-0. No abstract available.
- Background: PubMed 18546808Araujo M, Linder E, Wennstrom J, Lindhe J. The influence of Bio-Oss Collagen on healing of an extraction socket: an experimental study in the dog. Int J Periodontics Restorative Dent. 2008 Apr;28(2):123-35.
- Background: PubMed 24621203Araujo MG, da Silva JCC, de Mendonca AF, Lindhe J. Ridge alterations following grafting of fresh extraction sockets in man. A randomized clinical trial. Clin Oral Implants Res. 2015 Apr;26(4):407-412. doi: 10.1111/clr.12366. Epub 2014 Mar 12.
- Background: PubMed 20070748Araujo MG, Liljenberg B, Lindhe J. Dynamics of Bio-Oss Collagen incorporation in fresh extraction wounds: an experimental study in the dog. Clin Oral Implants Res. 2010 Jan;21(1):55-64. doi: 10.1111/j.1600-0501.2009.01854.x.
- Background: PubMed 15691354Araujo MG, Lindhe J. Dimensional ridge alterations following tooth extraction. An experimental study in the dog. J Clin Periodontol. 2005 Feb;32(2):212-8. doi: 10.1111/j.1600-051X.2005.00642.x.
- Background: PubMed 24966231Avila-Ortiz G, Elangovan S, Kramer KW, Blanchette D, Dawson DV. Effect of alveolar ridge preservation after tooth extraction: a systematic review and meta-analysis. J Dent Res. 2014 Oct;93(10):950-8. doi: 10.1177/0022034514541127. Epub 2014 Jun 25.
- Background: PubMed 18672985Barone A, Aldini NN, Fini M, Giardino R, Calvo Guirado JL, Covani U. Xenograft versus extraction alone for ridge preservation after tooth removal: a clinical and histomorphometric study. J Periodontol. 2008 Aug;79(8):1370-7. doi: 10.1902/jop.2008.070628.
- Background: PubMed 20572833Beitlitum I, Artzi Z, Nemcovsky CE. Clinical evaluation of particulate allogeneic with and without autogenous bone grafts and resorbable collagen membranes for bone augmentation of atrophic alveolar ridges. Clin Oral Implants Res. 2010 Nov;21(11):1242-50. doi: 10.1111/j.1600-0501.2010.01936.x.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos Garaicoa Pazmino, DDS principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing xenograft (BioOss Collagen) in people with Tooth Loss, run by University of Iowa at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants That Had an Implant That Survived 3 Years After Implant Placement (time frame: 3 years after implant placement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03659617, which also lists 46 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.