The Effect of Alveolar Ridge Preservation After Tooth Extraction in the Posterior Maxilla
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02952209|
Recruitment Status : Recruiting
First Posted : November 2, 2016
Last Update Posted : August 28, 2018
|Condition or disease||Intervention/treatment||Phase|
|Tooth Extraction||Device: Xenograft||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||The Effect of Alveolar Ridge Preservation After Tooth Extraction in the Posterior Maxilla: A Randomized, Split-Mouth, Controlled Trial.|
|Study Start Date :||October 2016|
|Estimated Primary Completion Date :||May 2019|
|Estimated Study Completion Date :||November 2019|
No Intervention: No Treatment
Tooth extraction with no bone graft.
Active Comparator: Alveolar Ridge Preservation Treatment
Tooth extraction followed by alveolar ridge preservation using xenograft bone graft and covered by a resorbable collagen membrane.
- 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.
- Alveolar bone volumetric changes measured in mm. [ Time Frame: 6 Months ]Alveolar bone volumetric changes measured using CBCT data and from dental impressions.
- Changes in the distance from the alveolar crestal bone to the sinus floor measured in mm. [ Time Frame: 6 months ]Changes in the distance from the alveolar crestal bone to the sinus floor using CBCT data and standardized periapical radiographs.
- Bone density changes from measured in mm. [ Time Frame: 6 Months ]Bone density changes measured using CBCT data.
- Changes in keratinized mucosa width and thickness measured in mm. [ Time Frame: 6 months ]Changes in keratinized mucosa width and thickness.
- Correlation of soft tissue and buccal bone wall thickness measured in mm. [ Time Frame: 6 months ]Correlation of soft tissue and buccal bone wall thickness on radiographic outcomes.
- Subject satisfaction will be assessed through questionnaire. [ Time Frame: 6 Months ]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.
- Need for additional bone augmentation, including sinus bone augmentation measured in mm. [ Time Frame: 1.5 Years ]Need for additional bone augmentation, including sinus bone augmentation, prior to implant placement at 6 months post extractions
- Implant success rate measured by percentage. [ Time Frame: 6 Months ]Evaluate dental implant success, in case the subject receives dental implant following healing of alveolar ridge after teeth extractions
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02952209
|Contact: Ismael E. Khouly, DDS, MS, PhD||212-998-9453||IEK3@nyu.edu|
|United States, New York|
|Bluestone Center for Clinical Research||Recruiting|
|New York, New York, United States, 10010|
|Contact: Ismael E. Khouly, DDS, MS, PhD 212-998-9456 IEK3@nyu.edu|
|Principal Investigator:||Ismael E. Khouly, DDS, MS, PhD||Bluestone Center for Clinical Research|