Use of Hyaluronic Acid as a Therapeutic Strategy for Bone Repair in Human

Phase 1

Completed

• Conditions: Alveolar Bone Loss
• Interventions: Other: Placebo; Drug: hyaluronic acid

• Registration Number: NCT02709525
• Lead Sponsor: Federal University of Minas Gerais

Brief Summary

The aim of this study is to evaluate the effects of hyaluronic acid (HA) on bone healing in human dental sockets.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Primary Completion: 2015-07
• Status Verified: 2016-03
• Study Completion: 2016-03
• Study First Submitted: 2016-03-08
• Study First Submitted QC: 2016-03-15
• Last Update Submitted: 2016-03-15
• Study First Posted: 2016-03-16
• Last Update Posted: 2016-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• Orthodontic need for bilateral extraction of lower first premolars

Exclusion Criteria

• Alcoholism, smoking, drug use and abuse of drugs; Systemic diseases: uncontrolled diabetes, blood dyscrasias, kidney or heart failure and osteoporosis; clinical or radiographic signs of pathological processes in the bone;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Blood clot	Placebo	Immediately after the extractions, the other side socket was naturally filled with blood clot.
hyaluronic acid	hyaluronic acid	Immediately after the extractions, one socket was randomly filled with 1% hyaluronic acid gel.

Primary Outcome Measures

Name	Time	Method
Fractal dimension	90 days after extraction and treatment application	During the postoperative interval of 90 days, the patients underwent cone beam computed tomography (CBCT). Five central transverse scan images were captured from each socket. The pattern of the alveolar trabecular bone was also evaluated through the fractal dimension in each image.
Dimensional Alveolar changes	30 to 90 days after extraction and treatment application	To determine whether treatment could prevent loss of buccolingual thickness, was compared bone loss of 90 to 30 days between the treated and control groups.
Percentage of bone formation	90 days after extraction and treatment application	During the postoperative interval of 90 days, the patients underwent cone beam computed tomography (CBCT). Five central transverse scan images were captured from each socket. Using the KS300 software, the gray intensity was measured in each image and the results were expressed as mean percentage of bone formation