Alveolar Ridge PreservationNCT05107141
Ridge Preservation in Molar Sites Comparing Xenograft Versus Mineralized Freeze-dried Bone Allograft
A study testing Ridge preservation and bone graft plus a collagen membrane in people with Alveolar Ridge Preservation, run by Universitat Internacional de Catalunya.
Trial summary
The objectives of the present investigation are; to compare the dimensional changes and the histological composition after the use of an allograft or xenograft and a resorbable membrane in ridge preservation in molar sites, to evaluate the influence of bone plates thickness on dimensional changes and the effectiveness… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alveolar Ridge Preservation
- What is being tested?
- Ridge preservation and bone graft plus a collagen membrane
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 9 Dec 2013to 7 Jun 2019
- 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
- Adult patients, over 18 years old.
- In need of removal of a maxillary or mandibular molar first or second molar.
- The molars to be extracted had to be bordered by at least one tooth.
- The molars had to have a presence of > 2 mm of keratinized gingiva and three intact bony walls.
- A dehiscence on the fourth wall, if any, had to be equal or less than 2 mm in height.
- Only one extraction per patient was accepted.
Who cannot join
- Acute periodontal or periapical infection.
- Pregnancy or lactancy.
- Smokers of more than 10 cigarettes per day.
- Previous adverse reactions to the biomaterials used in the study.
- Metabolic diseases affecting the mechanism of bone remodelling.
- Medications or treatments taken in the last twelve months and known to affect bone "turnover".
- Patients with poor plaque control -more than 20% (O'Leary, Drake, Naylor, 1972).
- Patients with absence of periodontal health maintenance or postoperative recommendations compliance.
About this study
Official title: Ridge Preservation in Molar Sites Comparing Xenograft Versus Mineralized Freeze-dried Bone Allograft: a Randomized Clinical Trial
The objectives of the present investigation are; to compare the dimensional changes and the histological composition after the use of an allograft or xenograft and a resorbable membrane in ridge preservation in molar sites, to evaluate the influence of bone plates thickness on dimensional changes and the effectiveness of ridge preservation in limiting the need of sinus elevation.
Read the detailed description
Twenty-four patients in need of maxillary or mandibular molar extraction and subsequent implant placement were included and randomly assigned to a group; allograft or xenograft, plus a collagen membrane. Cone Beam Computed Tomographies were obtained after molar extraction and after five months. A bone sample was harvested at the time of implant placement and analysed by histomorphometry.
- Conditions
- Alveolar Ridge Preservation
- Being tested
- Ridge preservation, bone graft plus a collagen membrane
- Keywords
- alveolar ridge preservation, molars, xenograft, allograft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ridge preservationProcedure or surgery
Ridge preservation in molar areas using a xenograft or an allograft in combination with a barrier collagen membrane
bone graft plus a collagen membraneDevice
| Study group | Role | What they receive |
|---|---|---|
| xenograft and a collagen membrane | Active comparator | Not described Receives: Procedure: Ridge preservation; Device: bone graft plus a collagen membrane |
| allograft and a collagen membrane | Active comparator | Not described Receives: Procedure: Ridge preservation; Device: bone graft plus a collagen membrane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of ridge dimensional changes following ridge preservation in molar sites comparing the use of freeze dried bone allograft (FDBA) or xenograft (DBBM), and a resorbable membrane.
To evaluate dimensional changes, the initial (CBCT1) and 5 months (CBCT2) CBCT images were processed and superimposed with the use of a specialized software image Simplant® O\&O (Denstply Sirona, Charlotte, NC, USA).
Measurements were expressed in millimeters (mm) and percentages showing changes in ridge width at 1mm, 3mm and 5mm from the bone crest.
The height of the buccal, and lingual bone crest was assessed, as well as the heigh in the central are of the socket.
Measured: 5 months
Secondary outcomes (2)
Evaluate the influence of buccal or lingual bone thickness on bone ridge changes
The width of the buccal and lingual bone plates was evaluated, by CBCT analysis, at 1mm, 3mm and 5mm to evaluate any correlation with bone dimensional changes after 5 months.
Data was expressed in milimeters.
Measured: 5 months
Evaluate the histologic composition of the regenerated areas after the use of freeze dried bone allograft (FDBA) or xenograft (DBBM), and a resorbable membrane.
The histomorphometric analysis was performed by the use of a specific software image (Image J®, Image Processing and Analysis in Java) and the areas occupied by vital bone (VB), non-mineralized connective tissue (NMCT) and graft particles (GP) were evaluated. The analysis of each tissue volume was expressed in percentages (%)
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2021
- Study start9 Dec 2013
- Primary completion7 Jun 2019
- Study completion7 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Alveolar Ridge PreservationStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitat Internacional de Catalunya
- Sponsor type
- University, hospital or other
- Collaborators
- BioHorizons, Inc., Geistlich Pharma AG, Dentsply Sirona Implants and Consumables
- Responsible party
- Principal investigator, Desire Abellán Iñiguez, Universitat Internacional de Catalunya
- Investigators
- Jose Nart Molina, Study director, Universitat Internacional de Catalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05107141
- Sponsor's protocol ID
- 2013-M-PER-ECL-2013-04
- Status last verified
- Oct 2021
- First submitted
- 10 Oct 2021
- Last updated
- 4 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Avila-Ortiz G, Chambrone L, Vignoletti F. Effect of alveolar ridge preservation interventions following tooth extraction: A systematic review and meta-analysis. J Clin Periodontol. 2019 Jun;46 Suppl 21:195-223. doi: 10.1111/jcpe.13057.
PubMed 30623987Nart 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 27335267Tonetti MS, Jung RE, Avila-Ortiz G, Blanco J, Cosyn J, Fickl S, Figuero E, Goldstein M, Graziani F, Madianos P, Molina A, Nart J, Salvi GE, Sanz-Martin I, Thoma D, Van Assche N, Vignoletti F. Management of the extraction socket and timing of implant placement: Consensus report and clinical recommendations of group 3 of the XV European Workshop in Periodontology. J Clin Periodontol. 2019 Jun;46 Suppl 21:183-194. doi: 10.1111/jcpe.13131.
PubMed 31215112Walker CJ, Prihoda TJ, Mealey BL, Lasho DJ, Noujeim M, Huynh-Ba G. Evaluation of Healing at Molar Extraction Sites With and Without Ridge Preservation: A Randomized Controlled Clinical Trial. J Periodontol. 2017 Mar;88(3):241-249. doi: 10.1902/jop.2016.160445. Epub 2016 Oct 27.
PubMed 27788625Duong M, Mealey BL, Walker C, Al-Harthi S, Prihoda TJ, Huynh-Ba G. Evaluation of healing at molar extraction sites with and without ridge preservation: A three-arm histologic analysis. J Periodontol. 2020 Jan;91(1):74-82. doi: 10.1002/JPER.19-0237. Epub 2019 Aug 11.
PubMed 31355447
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ridge Preservation in Molar Sites Comparing Xenograft Versus Mineralized Freeze-dried Bone Allograft: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05107141
- Acronym / sponsor ID
- 2013-M-PER-ECL-2013-04
- Conditions
- Alveolar Ridge Preservation
- Keywords
- alveolar ridge preservation, molars, xenograft, allograft
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Universitat Internacional de CatalunyaUniversity, hospital or other
- Collaborators
- BioHorizons, Inc., Geistlich Pharma AG, Dentsply Sirona Implants and Consumables
- Study start
- 9 Dec 2013 (actual)
- Primary completion
- 7 Jun 2019 (actual)
- Study completion
- 7 Jun 2019 (actual)
- First posted
- 4 Nov 2021 (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.
The objectives of the present investigation are; to compare the dimensional changes and the histological composition after the use of an allograft or xenograft and a resorbable membrane in ridge preservation in molar sites, to evaluate the influence of bone plates thickness on dimensional changes and the effectiveness of ridge preservation in limiting the need of sinus elevation.
Detailed description
Twenty-four patients in need of maxillary or mandibular molar extraction and subsequent implant placement were included and randomly assigned to a group; allograft or xenograft, plus a collagen membrane. Cone Beam Computed Tomographies were obtained after molar extraction and after five months. A bone sample was harvested at the time of implant placement and analysed by histomorphometry.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| xenograft and a collagen membrane | Active comparator | Procedure: Ridge preservation, Device: bone graft plus a collagen membrane |
| allograft and a collagen membrane | Active comparator | Procedure: Ridge preservation, Device: bone graft plus a collagen membrane |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult patients, over 18 years old.
- In need of removal of a maxillary or mandibular molar first or second molar.
- The molars to be extracted had to be bordered by at least one tooth.
- The molars had to have a presence of > 2 mm of keratinized gingiva and three intact bony walls.
- A dehiscence on the fourth wall, if any, had to be equal or less than 2 mm in height.
Key exclusion criteria (8 listed)
- Acute periodontal or periapical infection.
- Pregnancy or lactancy.
- Smokers of more than 10 cigarettes per day.
- Previous adverse reactions to the biomaterials used in the study.
- Metabolic diseases affecting the mechanism of bone remodelling.
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 |
|---|---|---|
| Ridge preservationRidge preservation in molar areas using a xenograft or an allograft in combination with a barrier collagen membrane | Procedure or surgery | allograft and a collagen membrane, xenograft and a collagen membrane |
| bone graft plus a collagen membrane | Device | allograft and a collagen membrane, xenograft and a collagen membrane |
Primary outcome
Evaluation of ridge dimensional changes following ridge preservation in molar sites comparing the use of freeze dried bone allograft (FDBA) or xenograft (DBBM), and a resorbable membrane.
Time frame: 5 months
To evaluate dimensional changes, the initial (CBCT1) and 5 months (CBCT2) CBCT images were processed and superimposed with the use of a specialized software image Simplant® O\&O (Denstply Sirona, Charlotte, NC, USA). Measurements were expressed in millimeters (mm) and percentages showing changes in ridge width at 1mm, 3mm and 5mm from the bone crest. The height of the buccal, and lingual bone crest was assessed, as well as the heigh in the central are of the socket.
2 secondary outcomes
Evaluate the influence of buccal or lingual bone thickness on bone ridge changes
Time frame: 5 months
Evaluate the histologic composition of the regenerated areas after the use of freeze dried bone allograft (FDBA) or xenograft (DBBM), and a resorbable membrane.
Time frame: 5 months
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 4 Nov 2021.
- Background: PubMed 30623987Avila-Ortiz G, Chambrone L, Vignoletti F. Effect of alveolar ridge preservation interventions following tooth extraction: A systematic review and meta-analysis. J Clin Periodontol. 2019 Jun;46 Suppl 21:195-223. doi: 10.1111/jcpe.13057.
- Background: 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.
- Background: PubMed 31215112Tonetti MS, Jung RE, Avila-Ortiz G, Blanco J, Cosyn J, Fickl S, Figuero E, Goldstein M, Graziani F, Madianos P, Molina A, Nart J, Salvi GE, Sanz-Martin I, Thoma D, Van Assche N, Vignoletti F. Management of the extraction socket and timing of implant placement: Consensus report and clinical recommendations of group 3 of the XV European Workshop in Periodontology. J Clin Periodontol. 2019 Jun;46 Suppl 21:183-194. doi: 10.1111/jcpe.13131.
- Background: PubMed 27788625Walker CJ, Prihoda TJ, Mealey BL, Lasho DJ, Noujeim M, Huynh-Ba G. Evaluation of Healing at Molar Extraction Sites With and Without Ridge Preservation: A Randomized Controlled Clinical Trial. J Periodontol. 2017 Mar;88(3):241-249. doi: 10.1902/jop.2016.160445. Epub 2016 Oct 27.
- Background: PubMed 31355447Duong M, Mealey BL, Walker C, Al-Harthi S, Prihoda TJ, Huynh-Ba G. Evaluation of healing at molar extraction sites with and without ridge preservation: A three-arm histologic analysis. J Periodontol. 2020 Jan;91(1):74-82. doi: 10.1002/JPER.19-0237. Epub 2019 Aug 11.
- 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.
Jose Nart Molina study director
Universitat Internacional de Catalunya
Questions about this trial
What is this clinical trial studying?
A study testing Ridge preservation and bone graft plus a collagen membrane in people with Alveolar Ridge Preservation, run by Universitat Internacional de Catalunya.
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 6 inclusion and 8 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 4 Nov 2021. 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?
Evaluation of ridge dimensional changes following ridge preservation in molar sites comparing the use of freeze dried bone allograft (FDBA) or xenograft (DBBM), and a resorbable membrane. (time frame: 5 months). 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 NCT05107141, which also lists 5 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 4 Nov 2021.