Ridge Preservation in Molar Sites Comparing Xenograft Versus Mineralized Freeze-dried Bone Allograft

October 24, 2021 updated by: Desire Abellán Iñiguez, Universitat Internacional de Catalunya

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

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
Active Comparator: xenograft and a collagen membrane
Procedure: Ridge preservation
Ridge preservation in molar areas using a xenograft or an allograft in combination with a barrier collagen membrane
Device: bone graft plus a collagen membrane
Active Comparator: allograft and a collagen membrane
Procedure: Ridge preservation
Ridge preservation in molar areas using a xenograft or an allograft in combination with a barrier collagen membrane
Device: bone graft plus a collagen membrane

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the influence of buccal or lingual bone thickness on bone ridge changes
Time Frame: 5 months

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.
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
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 (%)
5 months

Collaborators and Investigators

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

Sponsor

Universitat Internacional de Catalunya

Collaborators

Geistlich Pharma AG
BioHorizons, Inc.
Dentsply Sirona Implants and Consumables

Investigators

  • Study Director: Jose Nart Molina, Universitat Internacional de Catalunya

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)

December 9, 2013

Primary Completion (Actual)

June 7, 2019

Study Completion (Actual)

June 7, 2019

Study Registration Dates

First Submitted

October 10, 2021

First Submitted That Met QC Criteria

October 24, 2021

First Posted (Actual)

November 4, 2021

Study Record Updates

Last Update Posted (Actual)

November 4, 2021

Last Update Submitted That Met QC Criteria

October 24, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2013-M-PER-ECL-2013-04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

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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