Role of Hyaluronic Acid in Bone Healing After Dental Extraction

September 26, 2015 updated by: Damascus University

A Clinical and Experimental Study to Evaluate the Efficacy of Locally Applied Hyaluronic Acid in Bone Healing Following Dental Extraction

This is a randomized controlled trial with a split mouth design. Patients with an indication of lower dental extraction will be asked to join this research project at the Department of Oral and Maxillofacial Surgery at University of Damascus Dental School. Each patient whose case requires bilateral extraction, one side will serve as an experimental side, whereas the other side will serve as a control.

Participants should have symmetric teeth that need extraction in the lower jaw. Hyaluronic acid will be injected following extraction in one of the two sides with random allocation.

cone-beam computerized tomography (CBCT) images will be taken for each participant immediately post-extraction and at six months post-operatively.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

I- Clinical examination variables:

Buccolingual distance and distomesial distance will be measured for each participant at 2 assessment times: directly post-extraction and six months post-extraction.

II- Radiographic examination variables:

Linear measurements Vertical bone fill Bone mineral density

Study Type

Interventional

Enrollment (Actual)

20

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

  • Syrian Arab Republic
    • Damscus
      • Damascus, Damscus, Syrian Arab Republic, DM20AM18
        • Department of Oral and Maxillofacial Surgery, University of Damascus Dental School

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 to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18-60 years old
  • Symmetric teeth requiring extraction in the lower jaw
  • Systematically healthy

Exclusion Criteria:

  • Smokers
  • Pregnancy (for female participants)
  • Diabetic patients
  • Patients with metabolic problems

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: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hyaluronic Acid Group
In this Group, Hyaluronic acid will be injected following extraction.
Drug: Hyaluronic Acid
This material is going to be injected into the extraction socket in order to promote bone healing.
No Intervention: Traditional Extraction Group
In this group, traditional extraction procedures will be followed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in bone mineral density (BMD)
Time Frame: (BMD) will be measured two times in this study: directly at the day of extraction and six months post-extraction.
BMD is the amount of bone tissue in a certain volume of bone. This variable is going to be measured on CBCT images.
(BMD) will be measured two times in this study: directly at the day of extraction and six months post-extraction.
Vertical bone fill
Time Frame: This variable is going to be measured at 6 months post-extraction

'Vertical bone fill' is the distance between the base of the extraction socket and cement-enamel junction directly after extraction and minus the distance between base of the extraction socket and cement-enamel junction six months post-extraction.

This variable is going to be measured on CBCT images.
This variable is going to be measured at 6 months post-extraction

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Buccolingual distance
Time Frame: at six months post-extraction
Buccolingual distance is the distance between buccal wall and lingual wall of the extraction socket. This variable is going to be measured clinically.
at six months post-extraction
Mesiodistal distance
Time Frame: at six months post-extraction
Mesiodistal distance is the distance between mesial wall and distal wall of the extraction socket. This variable is going to be measured clinically.
at six months post-extraction

Collaborators and Investigators

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

Sponsor

Damascus University

Investigators

  • Principal Investigator: Sireen Abu Atta, DDS MSc, PhD student, Department of Oral and Maxillofacial Surgery, University of Damascus Dental School
  • Study Director: Mazen Zenati, DDS MSc PhD, Professor of Oral and Maxillofacial Surgery, University of Damsacus Dental School

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

December 1, 2014

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

January 1, 2015

First Submitted That Met QC Criteria

January 2, 2015

First Posted (Estimate)

January 5, 2015

Study Record Updates

Last Update Posted (Estimate)

September 29, 2015

Last Update Submitted That Met QC Criteria

September 26, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UDDS-OMFS-01-2015

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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