Alveolar Process AtrophyNCT03166475
Ridge Preservation With Provisional Ovoid Pontic
A study testing Surgical procedures in people with Alveolar Process Atrophy, run by Federal University of Juiz de Fora.
Trial summary
A prospective randomized controlled trial of 30 patients from the Faculty of Dentistry of the UFJF was conducted. It was included patients who presented indication of extraction of premolars, canines or incisors. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alveolar Process Atrophy
- What is being tested?
- Surgical procedures
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2016to 30 Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with indication of extraction of premolars, canines or incisors, which has two adjacent teeth, due to root fracture, extensive caries that did not allow unfavorable restorative and / or endodontic prognosis, systemically healthy.
Who cannot join
- Patients who use any drug that influences bone metabolism, patients with a history of head radiotherapy and neck, patients undergoing chemotherapy for the treatment of malignant tumors at the time of the study, patients with socket severely reabsorbed, smokers and pregnant women.
About this study
Official title: Ridge Preservation With Provisional Ovoid Pontic: a Randomized and Controlled Clinical-tomographic Trial
A prospective randomized controlled trial of 30 patients from the Faculty of Dentistry of the UFJF was conducted. It was included patients who presented indication of extraction of premolars, canines or incisors. All the thirty patients underwent dental extraction and were randomly divided into three groups according to the study methodology. Plaster casts and Cone-Beam Computed Tomography (CBCT) exams were performed for comparative analysis between sample groups and between study times ( imediate postoperative and four months later).
Read the detailed description
Thirty consecutive patients who presented at the Dentistry College of Federal University of Juiz de Fora (Brazil) were selected, requiring a single-tooth extraction of premolar, canines or incisors in maxilla. All of the patients included at this study signed a free and informed consent form, agreeing to participate voluntarily in this research. The study was approved by the Research Ethical Committee of the University of Juiz de Fora under the form 1.731.395.
The patients were randomly allocated in three groups according the following treatments:
- Group 1: Closure of the socket by primary intention through a palatal pedicle subepithelial connective tissue flap by the technique of Khoury \& Happe (2000) (Figure 1);
- Group 2: Filling the socket with a synthetic bone substitute of biphasic calcium phosphate (Bone Ceramic®, Straumann) and covering it with a palatal pedicle flap by the technique of Khoury \& Happe (2000) (Figure 2);
- Group 3: Sealing of the socket with a provisional ovoid pontic of acrylic resin (Figure 3).
As response factors were performed evaluations of study casts and tomographic analysis for dimensional stability evaluation of the sockets at immediate postoperative and after four months of the surgical procedures.
- Conditions
- Alveolar Process Atrophy
- Being tested
- Surgical procedures
- Medical subject headings
- Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical proceduresProcedure or surgery
All the extractions were performed under local anaesthesia, minimally traumatic as possible. After the extraction, each patient was treated according to the group of their allocations.
| Study group | Role | What they receive |
|---|---|---|
| Palatal pedicle flap (Group 1) | Experimental | On patients of this group were performed the palatal pedicle subepithelial connective tissue flap after the extraction, following the technique described by Khoury \& Happe (2000), which consists of total detachment of the palatal flap followed by division of the flap to release the connective tissue, maintain a pedicle and sliding it to cover the fresh socket by primary intention. The sutures were removed seven to ten days of postoperative. Receives: Procedure: Surgical procedures |
| Graft + palatal pedicle flap (Group 2) | Experimental | On patients of this group were performed the palatal pedicle flap like the group 1, however, the sockets were previously filled with a graft of synthetic bone substitute (Bone Ceramic®, Straumann, Switzerland) and then recovered with the connective flap and sutured by primary intention. The sutures were removed seven to ten days of postoperative. Receives: Procedure: Surgical procedures |
| Provisional ovoid pontic (Group 3) | Experimental | On patients of this group, after the extraction of the tooth, were made a provisional ovoid pontic with acrylic resin or with the crown of the removed tooth itself, cut and sealed with composite resin. The pontics were placed to seal the entire gingival margin of the socket and penetrating 2 to 3 mm into it, stabilized laterally by the adjacent teeth with orthodontic and composite resin or acrylic resin. No sutures were made. Receives: Procedure: Surgical procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of bone remodelation measured by Cone-Beam Computed Tomography exams and by plaster casts analysis, from baseline to 4 months
Will be measured width and height buccal-lingual of the ridge for each tooth extracted by the researcher.
Measured: Baseline (immediate postoperative) and 4 months after it.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2017
- Study start30 Sep 2016
- Primary completion10 Jan 2017
- Study completion30 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Alveolar Process AtrophyStudies 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
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Juiz de Fora
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruno Salles Sotto-Maior, Federal University of Juiz de Fora
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03166475
- Sponsor's protocol ID
- Reabilitação Oral
- Status last verified
- May 2017
- First submitted
- 22 May 2017
- Last updated
- 25 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared with other researchers, the data will be used for the same researcher on other research later.
Publications
Ten Heggeler JM, Slot DE, Van der Weijden GA. Effect of socket preservation therapies following tooth extraction in non-molar regions in humans: a systematic review. Clin Oral Implants Res. 2011 Aug;22(8):779-88. doi: 10.1111/j.1600-0501.2010.02064.x. Epub 2010 Nov 22.
PubMed 21091540Iocca O, Farcomeni A, Pardinas Lopez S, Talib HS. Alveolar ridge preservation after tooth extraction: a Bayesian Network meta-analysis of grafting materials efficacy on prevention of bone height and width reduction. J Clin Periodontol. 2017 Jan;44(1):104-114. doi: 10.1111/jcpe.12633. Epub 2016 Dec 5.
PubMed 27712001Nevins M, Camelo M, De Paoli S, Friedland B, Schenk RK, Parma-Benfenati S, Simion M, Tinti C, Wagenberg B. A study of the fate of the buccal wall of extraction sockets of teeth with prominent roots. Int J Periodontics Restorative Dent. 2006 Feb;26(1):19-29.
PubMed 16515093Araujo 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 24621203Schropp L, Wenzel A, Kostopoulos L, Karring T. Bone healing and soft tissue contour changes following single-tooth extraction: a clinical and radiographic 12-month prospective study. Int J Periodontics Restorative Dent. 2003 Aug;23(4):313-23.
PubMed 12956475Cardaropoli D, Tamagnone L, Roffredo A, Gaveglio L. Relationship between the buccal bone plate thickness and the healing of postextraction sockets with/without ridge preservation. Int J Periodontics Restorative Dent. 2014 Mar-Apr;34(2):211-7. doi: 10.11607/prd.1885.
PubMed 24600657Nart J, Barallat L, Jimenez D, Mestres J, Gomez A, Carrasco MA, Violant D, Ruiz-Magaz V. Radiographic and histological evaluation of deproteinized bovine bone mineral vs. deproteinized bovine bone mineral with 10% collagen in ridge preservation. A randomized controlled clinical trial. Clin Oral Implants Res. 2017 Jul;28(7):840-848. doi: 10.1111/clr.12889. Epub 2016 Jun 22.
PubMed 27335267Jung RE, Philipp A, Annen BM, Signorelli L, Thoma DS, Hammerle CH, Attin T, Schmidlin P. Radiographic evaluation of different techniques for ridge preservation after tooth extraction: a randomized controlled clinical trial. J Clin Periodontol. 2013 Jan;40(1):90-8. doi: 10.1111/jcpe.12027. Epub 2012 Nov 19.
PubMed 23163915Khoury F, Happe A. The palatal subepithelial connective tissue flap method for soft tissue management to cover maxillary defects: a clinical report. Int J Oral Maxillofac Implants. 2000 May-Jun;15(3):415-8.
PubMed 10874807Mardas N, Chadha V, Donos N. Alveolar ridge preservation with guided bone regeneration and a synthetic bone substitute or a bovine-derived xenograft: a randomized, controlled clinical trial. Clin Oral Implants Res. 2010 Jul;21(7):688-98. doi: 10.1111/j.1600-0501.2010.01918.x.
PubMed 20636724Ryu KH, Min S, You HK, Sin YW, Lee W, Lee J, Kiss A, Almohaimeed M, Zadeh HH. Alveolar ridge dimensional changes following ridge preservation procedure using SocketKAP() : exploratory study of serial cone-beam computed tomography and histologic analysis in canine model. Clin Oral Implants Res. 2016 Sep;27(9):1144-51. doi: 10.1111/clr.12711. Epub 2015 Dec 13.
PubMed 26660705Fickl S, Fischer K, Petersen N, Happe A, Schlee M, Schlagenhauf U, Kebschull M. Dimensional Evaluation of Different Ridge Preservation Techniques: A Randomized Clinical Study. Int J Periodontics Restorative Dent. 2017 May/Jun;37(3):403-410. doi: 10.11607/prd.2629.
PubMed 28402351
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ridge Preservation With Provisional Ovoid Pontic: a Randomized and Controlled Clinical-tomographic Trial
- ClinicalTrials.gov ID
- NCT03166475
- Acronym / sponsor ID
- Reabilitação Oral
- Conditions
- Alveolar Process Atrophy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Federal University of Juiz de ForaUniversity, hospital or other
- Study start
- 30 Sep 2016 (actual)
- Primary completion
- 10 Jan 2017 (actual)
- Study completion
- 30 Mar 2017 (actual)
- First posted
- 25 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective randomized controlled trial of 30 patients from the Faculty of Dentistry of the UFJF was conducted. It was included patients who presented indication of extraction of premolars, canines or incisors. All the thirty patients underwent dental extraction and were randomly divided into three groups according to the study methodology. Plaster casts and Cone-Beam Computed Tomography (CBCT) exams were performed for comparative analysis between sample groups and between study times ( imediate postoperative and four months later).
Detailed description
Thirty consecutive patients who presented at the Dentistry College of Federal University of Juiz de Fora (Brazil) were selected, requiring a single-tooth extraction of premolar, canines or incisors in maxilla. All of the patients included at this study signed a free and informed consent form, agreeing to participate voluntarily in this research. The study was approved by the Research Ethical Committee of the University of Juiz de Fora under the form 1.731.395.
The patients were randomly allocated in three groups according the following treatments:
- Group 1: Closure of the socket by primary intention through a palatal pedicle subepithelial connective tissue flap by the technique of Khoury \& Happe (2000) (Figure 1);
- Group 2: Filling the socket with a synthetic bone substitute of biphasic calcium phosphate (Bone Ceramic®, Straumann) and covering it with a palatal pedicle flap by the technique of Khoury \& Happe (2000) (Figure 2);
- Group 3: Sealing of the socket with a provisional ovoid pontic of acrylic resin (Figure 3).
As response factors were performed evaluations of study casts and tomographic analysis for dimensional stability evaluation of the sockets at immediate postoperative and after four months of the surgical procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Palatal pedicle flap (Group 1) | Experimental | Procedure: Surgical proceduresOn patients of this group were performed the palatal pedicle subepithelial connective tissue flap after the extraction, following the technique described by Khoury \& Happe (2000), which consists of total detachment of the palatal flap followed by division of the flap to release the connective tissue, maintain a pedicle and sliding it to cover the fresh socket by primary intention. The sutures were removed seven to ten days of postoperative. |
| Graft + palatal pedicle flap (Group 2) | Experimental | Procedure: Surgical proceduresOn patients of this group were performed the palatal pedicle flap like the group 1, however, the sockets were previously filled with a graft of synthetic bone substitute (Bone Ceramic®, Straumann, Switzerland) and then recovered with the connective flap and sutured by primary intention. The sutures were removed seven to ten days of postoperative. |
| Provisional ovoid pontic (Group 3) | Experimental | Procedure: Surgical proceduresOn patients of this group, after the extraction of the tooth, were made a provisional ovoid pontic with acrylic resin or with the crown of the removed tooth itself, cut and sealed with composite resin. The pontics were placed to seal the entire gingival margin of the socket and penetrating 2 to 3 mm into it, stabilized laterally by the adjacent teeth with orthodontic and composite resin or acrylic resin. No sutures were made. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with indication of extraction of premolars, canines or incisors, which has two adjacent teeth, due to root fracture, extensive caries that did not allow unfavorable restorative and / or endodontic prognosis, systemically healthy.
Key exclusion criteria (1 listed)
- Patients who use any drug that influences bone metabolism, patients with a history of head radiotherapy and neck, patients undergoing chemotherapy for the treatment of malignant tumors at the time of the study, patients with socket severely reabsorbed, smokers and pregnant women.
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 |
|---|---|---|
| Surgical proceduresAll the extractions were performed under local anaesthesia, minimally traumatic as possible. After the extraction, each patient was treated according to the group of their allocations. | Procedure or surgery | Graft + palatal pedicle flap (Group 2), Palatal pedicle flap (Group 1), Provisional ovoid pontic (Group 3) |
Primary outcome
Changes of bone remodelation measured by Cone-Beam Computed Tomography exams and by plaster casts analysis, from baseline to 4 months
Time frame: Baseline (immediate postoperative) and 4 months after it.
Will be measured width and height buccal-lingual of the ridge for each tooth extracted by the researcher.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2017.
- Results publication: PubMed 21091540Ten Heggeler JM, Slot DE, Van der Weijden GA. Effect of socket preservation therapies following tooth extraction in non-molar regions in humans: a systematic review. Clin Oral Implants Res. 2011 Aug;22(8):779-88. doi: 10.1111/j.1600-0501.2010.02064.x. Epub 2010 Nov 22.
- Results publication: PubMed 27712001Iocca O, Farcomeni A, Pardinas Lopez S, Talib HS. Alveolar ridge preservation after tooth extraction: a Bayesian Network meta-analysis of grafting materials efficacy on prevention of bone height and width reduction. J Clin Periodontol. 2017 Jan;44(1):104-114. doi: 10.1111/jcpe.12633. Epub 2016 Dec 5.
- Results publication: PubMed 16515093Nevins M, Camelo M, De Paoli S, Friedland B, Schenk RK, Parma-Benfenati S, Simion M, Tinti C, Wagenberg B. A study of the fate of the buccal wall of extraction sockets of teeth with prominent roots. Int J Periodontics Restorative Dent. 2006 Feb;26(1):19-29.
- Results publication: 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.
- Results publication: PubMed 12956475Schropp L, Wenzel A, Kostopoulos L, Karring T. Bone healing and soft tissue contour changes following single-tooth extraction: a clinical and radiographic 12-month prospective study. Int J Periodontics Restorative Dent. 2003 Aug;23(4):313-23.
- Results publication: PubMed 24600657Cardaropoli D, Tamagnone L, Roffredo A, Gaveglio L. Relationship between the buccal bone plate thickness and the healing of postextraction sockets with/without ridge preservation. Int J Periodontics Restorative Dent. 2014 Mar-Apr;34(2):211-7. doi: 10.11607/prd.1885.
- Results publication: PubMed 27335267Nart J, Barallat L, Jimenez D, Mestres J, Gomez A, Carrasco MA, Violant D, Ruiz-Magaz V. Radiographic and histological evaluation of deproteinized bovine bone mineral vs. deproteinized bovine bone mineral with 10% collagen in ridge preservation. A randomized controlled clinical trial. Clin Oral Implants Res. 2017 Jul;28(7):840-848. doi: 10.1111/clr.12889. Epub 2016 Jun 22.
- Results publication: PubMed 23163915Jung RE, Philipp A, Annen BM, Signorelli L, Thoma DS, Hammerle CH, Attin T, Schmidlin P. Radiographic evaluation of different techniques for ridge preservation after tooth extraction: a randomized controlled clinical trial. J Clin Periodontol. 2013 Jan;40(1):90-8. doi: 10.1111/jcpe.12027. Epub 2012 Nov 19.
- Results publication: PubMed 10874807Khoury F, Happe A. The palatal subepithelial connective tissue flap method for soft tissue management to cover maxillary defects: a clinical report. Int J Oral Maxillofac Implants. 2000 May-Jun;15(3):415-8.
- Results publication: PubMed 20636724Mardas N, Chadha V, Donos N. Alveolar ridge preservation with guided bone regeneration and a synthetic bone substitute or a bovine-derived xenograft: a randomized, controlled clinical trial. Clin Oral Implants Res. 2010 Jul;21(7):688-98. doi: 10.1111/j.1600-0501.2010.01918.x.
- Results publication: PubMed 26660705Ryu KH, Min S, You HK, Sin YW, Lee W, Lee J, Kiss A, Almohaimeed M, Zadeh HH. Alveolar ridge dimensional changes following ridge preservation procedure using SocketKAP() : exploratory study of serial cone-beam computed tomography and histologic analysis in canine model. Clin Oral Implants Res. 2016 Sep;27(9):1144-51. doi: 10.1111/clr.12711. Epub 2015 Dec 13.
- Results publication: PubMed 28402351Fickl S, Fischer K, Petersen N, Happe A, Schlee M, Schlagenhauf U, Kebschull M. Dimensional Evaluation of Different Ridge Preservation Techniques: A Randomized Clinical Study. Int J Periodontics Restorative Dent. 2017 May/Jun;37(3):403-410. doi: 10.11607/prd.2629.
- Individual participant dataSharing planned: No. IPD will not be shared with other researchers, the data will be used for the same researcher on other research later.
Related trials for Alveolar Process Atrophy
Recruiting
Effect of Collagen Membrane on Ridge Preservation
Dehiscence, Tooth Extraction
Recruiting
Melatonin Effect on Immediate Dental Implants in the Posterior Mandible
Dental Implant, Immediate Dental Implant Placement
Not yet recruiting
Bone and Soft Tissue Healing After Socket Preservation With NOVAMag or Permamem Membranes
Alveolar Bone Loss, Tooth Loss / Rehabilitation
Recruiting
Bone Marrow Mononuclear Cells for the Repair of Severe Maxillofacial Bone Defects
Maxillofacial Bone Defect, Alveolar Bone Loss
Recruiting
Histological and Histomorphometric Assessment With Inflammatory Profile Analysis of Bone Tissue After Horizontal Ridge Augmentation Using Customized Porous Zirconia Shell
Alveolar Bone Loss, Alveolar Ridge Deficiency
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical procedures in people with Alveolar Process Atrophy, run by Federal University of Juiz de Fora.
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 1 inclusion and 1 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 25 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes of bone remodelation measured by Cone-Beam Computed Tomography exams and by plaster casts analysis, from baseline to 4 months (time frame: Baseline (immediate postoperative) and 4 months after it.). 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 NCT03166475, which also lists 12 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 25 May 2017.