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

March 6, 2021 updated by: Ismael Khouly, NYU College of Dentistry

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10010
        • Bluestone Center for Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 Months
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.
6 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alveolar bone volumetric changes measured in mm.
Time Frame: 6 Months
Alveolar bone volumetric changes measured using CBCT data and from dental impressions.
6 Months
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.
6 months
Bone density changes from measured in mm.
Time Frame: 6 Months
Bone density changes measured using CBCT data.
6 Months
Changes in keratinized mucosa width and thickness measured in mm.
Time Frame: 6 months
Changes in keratinized mucosa width and thickness.
6 months
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 months
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.
6 Months
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
1.5 Years
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
6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU College of Dentistry

Collaborators

Osteo Science Foundation

Investigators

  • Principal Investigator: Ismael E. Khouly, DDS, MS, PhD, Bluestone Center for Clinical Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 27, 2016

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

October 31, 2016

First Submitted That Met QC Criteria

October 31, 2016

First Posted (Estimate)

November 2, 2016

Study Record Updates

Last Update Posted (Actual)

March 9, 2021

Last Update Submitted That Met QC Criteria

March 6, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 16-01597

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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