Completed

NCT Number: NCT02330822

Role of Hyaluronic Acid in Bone Healing After 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.

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Key information

Conditions

Patients With Dental Extraction

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Oral and Maxillofacial Surgery, University of Damascus Dental School

Damascus, Damscus, DM20AM18, Syria

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hyaluronic acid

Drug

This material is going to be injected into the extraction socket in order to promote bone healing.

Primary outcomes

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.
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.

Secondary outcomes

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.
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.

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study title

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

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Jan 5, 2015
Registry last updated: Sep 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.