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The Effect of Alveolar Ridge Preservation After Tooth Extraction in the Posterior Maxilla

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ClinicalTrials.gov Identifier: NCT02952209
Recruitment Status : Recruiting
First Posted : November 2, 2016
Last Update Posted : December 13, 2017
Sponsor:
Collaborator:
Osteo Science Foundation
Information provided by (Responsible Party):
Ismael Khouly, NYU College of Dentistry

Brief 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.

Condition or disease Intervention/treatment Phase
Tooth Extraction Device: Xenograft Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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 2018
Estimated Study Completion Date : November 2018

Arm Intervention/treatment
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.
Device: Xenograft



Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Alveolar bone volumetric changes measured in mm. [ Time Frame: 6 Months ]
    Alveolar bone volumetric changes measured using CBCT data and from dental impressions.

  2. 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.

  3. Bone density changes from measured in mm. [ Time Frame: 6 Months ]
    Bone density changes measured using CBCT data.

  4. Changes in keratinized mucosa width and thickness measured in mm. [ Time Frame: 6 months ]
    Changes in keratinized mucosa width and thickness.

  5. 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.

  6. 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.

  7. 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

  8. 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



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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Subjects must voluntarily sign the informed consent form.
  2. Subjects must be male or female who are at least 20-70 years of age.
  3. Subjects must be able and willing to follow study procedures and instructions.
  4. 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.
  5. 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).
  6. If present, teeth adjacent to the teeth slated for extraction must be healthy. Healthy teeth are defined as asymptomatic teeth without periapical lesions.

Exclusion Criteria:

  1. Female subjects who are pregnant or lactating, or who intend to become pregnant during the study period following entrance into the study.
  2. Subjects who have failed to maintain good plaque control.
  3. 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.
  4. Subjects who report allergy or hypersensitivity to any of the products (collagen membrane and ABBM) used throughout the study.
  5. Presence of ≥3 mm of vertical loss of the buccal bone in relation to the palatal wall.
  6. Subjects with untreated periodontitis.
  7. Presence of acute dentoalveolar infections in the teeth slated for extraction.
  8. 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.
  9. 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

Information from the National Library of Medicine

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


Contacts
Contact: Ismael E. Khouly, DDS, MS, PhD 212-998-9453 IEK3@nyu.edu

Locations
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   
Sponsors and Collaborators
NYU College of Dentistry
Osteo Science Foundation
Investigators
Principal Investigator: Ismael E. Khouly, DDS, MS, PhD Bluestone Center for Clinical Research

Publications:

Responsible Party: Ismael Khouly, Associate Director of Periodontology & Implant Dentistry, NYU College of Dentistry
ClinicalTrials.gov Identifier: NCT02952209     History of Changes
Other Study ID Numbers: 16-01597
First Posted: November 2, 2016    Key Record Dates
Last Update Posted: December 13, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Ismael Khouly, NYU College of Dentistry:
Alveolar Ridge Preservation
Xenograft bone graft
Collagen membrane