Tooth ExtractionNCT02952209
The Effect of Alveolar Ridge Preservation After Tooth Extraction in the Posterior Maxilla
A study testing Xenograft in people with Tooth Extraction, run by NYU College of Dentistry at 1 site in United States.
Trial summary
This study is designed to assess the effects of Alveolar Ridge Preservation (ARP) after tooth extraction compared to extraction alone in the posterior maxilla. The results of this study will demonstrate if the use of ARP reduces alveolar ridge resorption at 6 months post extraction in the posterior maxilla region. Read more about this study
- Who is it for?
- Ages 20 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Extraction
- What is being tested?
- Xenograft
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Sep 2016to Dec 2021
- 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 20 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects must voluntarily sign the informed consent form.
- Subjects must be male or female who are at least 20-70 years of age.
- Subjects must be able and willing to follow study procedures and instructions.
- Presence of one posterior tooth in the right maxilla and one posterior tooth in the left maxilla that require extraction (ADA tooth positions 2-4 and 13-15). The same type of tooth should be in booth side, either two molars or two premolars.
- Teeth extractions of one posterior tooth in the right maxilla and one posterior tooth in the left maxilla must be completed successfully (ADA tooth positions 2-4 and 13-15).
- If present, teeth adjacent to the teeth slated for extraction must be healthy. Healthy teeth are defined as asymptomatic teeth without periapical lesions.
Who cannot join
- Female subjects who are pregnant or lactating, or who intend to become pregnant during the study period following entrance into the study.
- Subjects who have failed to maintain good plaque control.
- Subjects with any systemic condition such as uncontrolled diabetes mellitus, cancer, HIV, disorders that compromise wound healing, chronic high dose steroid therapy, intravenous and oral bisphosphonate therapy, bone metabolic diseases, history of irradiation of the head and neck area, or any other immuno-suppressive therapy that would contraindicate oral surgical treatment.
- Subjects who report allergy or hypersensitivity to any of the products (collagen membrane and ABBM) used throughout the study.
- Presence of ≥3 mm of vertical loss of the buccal bone in relation to the palatal wall.
- Subjects with untreated periodontitis.
Show all 9Show fewer
- Presence of acute dentoalveolar infections in the teeth slated for extraction.
- Subjects who are heavy smokers (defined as >10 cigarettes per day or >1 cigar per day) or chew tobacco, including within 3 months prior to enrollment.
- Subjects with conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non- compliance or unreliability
Trial locations and contacts
1 site in 1 country.
United States1 site
Bluestone Center for Clinical Research
New York, New York, 10010
About this study
Official title: The Effect of Alveolar Ridge Preservation After Tooth Extraction in the Posterior Maxilla: A Randomized, Split-Mouth, Controlled Trial.
This study is designed to assess the effects of Alveolar Ridge Preservation (ARP) after tooth extraction compared to extraction alone in the posterior maxilla. The results of this study will demonstrate if the use of ARP reduces alveolar ridge resorption at 6 months post extraction in the posterior maxilla region.
Read the detailed description
Fifteen subjects requiring extraction of one posterior tooth in the right maxilla and one posterior tooth in the left maxilla will be considered for enrollment. Subjects who meet the inclusion and exclusion criteria will be randomized to receive alveolar ridge preservation on one side of the maxilla and only an extraction on the other side of the maxilla.
Extraction of the failing teeth will be performed atraumatically; a mucoperiosteal flap will not be employed. After removal of the tooth, the alveolus will be meticulously debrided and cleaned. In the test site, the socket will be filled with xenograft and a collagen membrane. In the control site, no graft material or collagen membrane will be used. Clinical measurements, standardized peri-apical radiographs and Cone Beam Computed Tomography scans will be performed immediately following tooth extractions (visit 2) and 6 months (visit 4) after extractions.
Subjects will be examined over the course of 6 months. Investigators will be trained prior to participating in the study. Training will be undertaken during a site initiation visit and will include a detailed description of all study procedures including treatment methods, and measurement methods to obtain study endpoints.
- Conditions
- Tooth Extraction
- Being tested
- Xenograft
- Keywords
- Alveolar Ridge Preservation, Xenograft bone graft, Collagen membrane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XenograftDevice
| Study group | Role | What they receive |
|---|---|---|
| No Treatment | No intervention | Tooth extraction with no bone graft. |
| Alveolar Ridge Preservation Treatment | Active comparator | Tooth extraction followed by alveolar ridge preservation using xenograft bone graft and covered by a resorbable collagen membrane. Receives: Device: Xenograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the bucco-palatal width of the alveolar ridge measured in mm.
Changes in the bucco-palatal width of alveolar ridge from baseline to 6 months, measured using CBCT data.
Measured: 6 Months
Changes in the vertical height of the alveolar ridge measured in mm.
Changes in the vertical height of the alveolar ridge measured using Cone Beam Computed Tomography (CBCT) data and periapical radiographs.
Measured: 6 Months
Secondary outcomes (8)
Alveolar bone volumetric changes measured in mm.
Alveolar bone volumetric changes measured using CBCT data and from dental impressions.
Measured: 6 Months
Changes in the distance from the alveolar crestal bone to the sinus floor measured in mm.
Changes in the distance from the alveolar crestal bone to the sinus floor using CBCT data and standardized periapical radiographs.
Measured: 6 months
Bone density changes from measured in mm.
Bone density changes measured using CBCT data.
Measured: 6 Months
Changes in keratinized mucosa width and thickness measured in mm.
Changes in keratinized mucosa width and thickness.
Measured: 6 months
Correlation of soft tissue and buccal bone wall thickness measured in mm.
Correlation of soft tissue and buccal bone wall thickness on radiographic outcomes.
Measured: 6 months
Subject satisfaction will be assessed through questionnaire.
Subject satisfaction will be assessed using a Visual Analogue Scale (VAS) (scored from 0-100) after extraction (visit 2), at 2 weeks (visit 3) and 6 months (visit 4) following tooth extractions.
Measured: 6 Months
Need for additional bone augmentation, including sinus bone augmentation measured in mm.
Need for additional bone augmentation, including sinus bone augmentation, prior to implant placement at 6 months post extractions
Measured: 1.5 Years
Implant success rate measured by percentage.
Evaluate dental implant success, in case the subject receives dental implant following healing of alveolar ridge after teeth extractions
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2016 (estimated)
- Study start27 Sep 2016
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
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 Tooth ExtractionStudies 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, Outcomes assessor
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU College of Dentistry
- Sponsor type
- University, hospital or other
- Collaborators
- Osteo Science Foundation
- Responsible party
- Principal investigator, Ismael Khouly, NYU College of Dentistry
- Investigators
- Ismael E. Khouly, DDS, MS, PhD, Principal investigator, Bluestone Center for Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02952209
- Sponsor's protocol ID
- 16-01597
- Status last verified
- Mar 2021
- First submitted
- 31 Oct 2016
- Last updated
- 9 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Araujo 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. Socket grafting with the use of autologous bone: an experimental study in the dog. Clin Oral Implants Res. 2011 Jan;22(1):9-13. doi: 10.1111/j.1600-0501.2010.01937.x. Epub 2010 Nov 22.
PubMed 21091539Carmagnola D, Adriaens P, Berglundh T. Healing of human extraction sockets filled with Bio-Oss. Clin Oral Implants Res. 2003 Apr;14(2):137-43. doi: 10.1034/j.1600-0501.2003.140201.x.
PubMed 12656871Ashman A. Postextraction ridge preservation using a synthetic alloplast. Implant Dent. 2000;9(2):168-76. doi: 10.1097/00008505-200009020-00011.
PubMed 11307396Atieh MA, Alsabeeha NH, Payne AG, Duncan W, Faggion CM, Esposito M. Interventions for replacing missing teeth: alveolar ridge preservation techniques for dental implant site development. Cochrane Database Syst Rev. 2015 May 28;2015(5):CD010176. doi: 10.1002/14651858.CD010176.pub2.
PubMed 26020735Avila-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 24966231Camargo PM, Lekovic V, Weinlaender M, Klokkevold PR, Kenney EB, Dimitrijevic B, Nedic M, Jancovic S, Orsini M. Influence of bioactive glass on changes in alveolar process dimensions after exodontia. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2000 Nov;90(5):581-6. doi: 10.1067/moe.2000.110035.
PubMed 11077380Greenstein G, Jaffin RA, Hilsen KL, Berman CL. Repair of anterior gingival deformity with durapatite. A case report. J Periodontol. 1985 Apr;56(4):200-3. doi: 10.1902/jop.1985.56.4.200.
PubMed 2987474Norton MR, Wilson J. Dental implants placed in extraction sites implanted with bioactive glass: human histology and clinical outcome. Int J Oral Maxillofac Implants. 2002 Mar-Apr;17(2):249-57.
PubMed 11958408Rasperini G, Canullo L, Dellavia C, Pellegrini G, Simion M. Socket grafting in the posterior maxilla reduces the need for sinus augmentation. Int J Periodontics Restorative Dent. 2010 Jun;30(3):265-73.
PubMed 20386783Schropp 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 12956475Soehren SE, Van Swol RL. The healing extraction site: a donor area for periodontal grafting material. J Periodontol. 1979 Mar;50(3):128-33. doi: 10.1902/jop.1979.50.3.128.
PubMed 285263
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Alveolar Ridge Preservation After Tooth Extraction in the Posterior Maxilla: A Randomized, Split-Mouth, Controlled Trial.
- ClinicalTrials.gov ID
- NCT02952209
- Acronym / sponsor ID
- 16-01597
- Conditions
- Tooth Extraction
- Keywords
- Alveolar Ridge Preservation, Xenograft bone graft, Collagen membrane
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- NYU College of DentistryUniversity, hospital or other
- Collaborators
- Osteo Science Foundation
- Study start
- 27 Sep 2016 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 2 Nov 2016 (estimated)
- 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.
This study is designed to assess the effects of Alveolar Ridge Preservation (ARP) after tooth extraction compared to extraction alone in the posterior maxilla. The results of this study will demonstrate if the use of ARP reduces alveolar ridge resorption at 6 months post extraction in the posterior maxilla region.
Detailed description
Fifteen subjects requiring extraction of one posterior tooth in the right maxilla and one posterior tooth in the left maxilla will be considered for enrollment. Subjects who meet the inclusion and exclusion criteria will be randomized to receive alveolar ridge preservation on one side of the maxilla and only an extraction on the other side of the maxilla.
Extraction of the failing teeth will be performed atraumatically; a mucoperiosteal flap will not be employed. After removal of the tooth, the alveolus will be meticulously debrided and cleaned. In the test site, the socket will be filled with xenograft and a collagen membrane. In the control site, no graft material or collagen membrane will be used. Clinical measurements, standardized peri-apical radiographs and Cone Beam Computed Tomography scans will be performed immediately following tooth extractions (visit 2) and 6 months (visit 4) after extractions.
Subjects will be examined over the course of 6 months. Investigators will be trained prior to participating in the study. Training will be undertaken during a site initiation visit and will include a detailed description of all study procedures including treatment methods, and measurement methods to obtain study endpoints.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Treatment | No intervention | –Tooth extraction with no bone graft. |
| Alveolar Ridge Preservation Treatment | Active comparator | Device: XenograftTooth extraction followed by alveolar ridge preservation using xenograft bone graft and covered by a resorbable collagen membrane. |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects must voluntarily sign the informed consent form.
- Subjects must be male or female who are at least 20-70 years of age.
- Subjects must be able and willing to follow study procedures and instructions.
- Presence of one posterior tooth in the right maxilla and one posterior tooth in the left maxilla that require extraction (ADA tooth positions 2-4 and 13-15). The same type of tooth should be in booth side, either two molars or two premolars.
- Teeth extractions of one posterior tooth in the right maxilla and one posterior tooth in the left maxilla must be completed successfully (ADA tooth positions 2-4 and 13-15).
Key exclusion criteria (9 listed)
- Female subjects who are pregnant or lactating, or who intend to become pregnant during the study period following entrance into the study.
- Subjects who have failed to maintain good plaque control.
- Subjects with any systemic condition such as uncontrolled diabetes mellitus, cancer, HIV, disorders that compromise wound healing, chronic high dose steroid therapy, intravenous and oral bisphosphonate therapy, bone metabolic diseases, history of irradiation of the head and neck area, or any other immuno-suppressive therapy that would contraindicate oral surgical treatment.
- Subjects who report allergy or hypersensitivity to any of the products (collagen membrane and ABBM) used throughout the study.
- Presence of ≥3 mm of vertical loss of the buccal bone in relation to the palatal wall.
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 | Device | Alveolar Ridge Preservation Treatment |
Primary outcome
Changes in the bucco-palatal width of the alveolar ridge measured in mm.
Time frame: 6 Months
Changes in the bucco-palatal width of alveolar ridge from baseline to 6 months, measured using CBCT data.
Changes in the vertical height of the alveolar ridge measured in mm.
Time frame: 6 Months
Changes in the vertical height of the alveolar ridge measured using Cone Beam Computed Tomography (CBCT) data and periapical radiographs.
8 secondary outcomes
Alveolar bone volumetric changes measured in mm.
Time frame: 6 Months
Changes in the distance from the alveolar crestal bone to the sinus floor measured in mm.
Time frame: 6 months
Bone density changes from measured in mm.
Time frame: 6 Months
Changes in keratinized mucosa width and thickness measured in mm.
Time frame: 6 months
Correlation of soft tissue and buccal bone wall thickness measured in mm.
Time frame: 6 months
Subject satisfaction will be assessed through questionnaire.
Time frame: 6 Months
Need for additional bone augmentation, including sinus bone augmentation measured in mm.
Time frame: 1.5 Years
Implant success rate measured by percentage.
Time frame: 6 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2021.
- 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 21091539Araujo MG, Lindhe J. Socket grafting with the use of autologous bone: an experimental study in the dog. Clin Oral Implants Res. 2011 Jan;22(1):9-13. doi: 10.1111/j.1600-0501.2010.01937.x. Epub 2010 Nov 22.
- Background: PubMed 12656871Carmagnola D, Adriaens P, Berglundh T. Healing of human extraction sockets filled with Bio-Oss. Clin Oral Implants Res. 2003 Apr;14(2):137-43. doi: 10.1034/j.1600-0501.2003.140201.x.
- Background: PubMed 11307396Ashman A. Postextraction ridge preservation using a synthetic alloplast. Implant Dent. 2000;9(2):168-76. doi: 10.1097/00008505-200009020-00011.
- Background: PubMed 26020735Atieh MA, Alsabeeha NH, Payne AG, Duncan W, Faggion CM, Esposito M. Interventions for replacing missing teeth: alveolar ridge preservation techniques for dental implant site development. Cochrane Database Syst Rev. 2015 May 28;2015(5):CD010176. doi: 10.1002/14651858.CD010176.pub2.
- 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 11077380Camargo PM, Lekovic V, Weinlaender M, Klokkevold PR, Kenney EB, Dimitrijevic B, Nedic M, Jancovic S, Orsini M. Influence of bioactive glass on changes in alveolar process dimensions after exodontia. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2000 Nov;90(5):581-6. doi: 10.1067/moe.2000.110035.
- Background: PubMed 2987474Greenstein G, Jaffin RA, Hilsen KL, Berman CL. Repair of anterior gingival deformity with durapatite. A case report. J Periodontol. 1985 Apr;56(4):200-3. doi: 10.1902/jop.1985.56.4.200.
- Background: PubMed 11958408Norton MR, Wilson J. Dental implants placed in extraction sites implanted with bioactive glass: human histology and clinical outcome. Int J Oral Maxillofac Implants. 2002 Mar-Apr;17(2):249-57.
- Background: PubMed 20386783Rasperini G, Canullo L, Dellavia C, Pellegrini G, Simion M. Socket grafting in the posterior maxilla reduces the need for sinus augmentation. Int J Periodontics Restorative Dent. 2010 Jun;30(3):265-73.
- Background: 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.
- Background: PubMed 285263Soehren SE, Van Swol RL. The healing extraction site: a donor area for periodontal grafting material. J Periodontol. 1979 Mar;50(3):128-33. doi: 10.1902/jop.1979.50.3.128.
- 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.
Ismael E. Khouly, DDS, MS, PhD principal investigator
Bluestone Center for Clinical Research
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 in people with Tooth Extraction, run by NYU College of Dentistry 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 6 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: status not confirmed, as of the sponsor's last update on 9 Mar 2021. 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?
Results are not available in the source record.
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 in the bucco-palatal width of the alveolar ridge measured in mm. (time frame: 6 Months). The study lists 2 primary outcomes in all. 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 NCT02952209, 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 9 Mar 2021.