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

Use of Hyaluronic Acid as a Therapeutic Strategy for Bone Repair in Human: a Split-mouth Randomized Triple-blind Clinical Trial

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

Study Overview

• Status: Completed
• Conditions: Alveolar Bone Loss
• Intervention / Treatment: Other: Placebo; Drug: hyaluronic acid

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 2; Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 40 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: hyaluronic acid; Immediately after the extractions, one socket was randomly filled with 1% hyaluronic acid gel.	Drug: hyaluronic acid; Other Names: Sodium hyaluronate; Hyaluronan
Placebo Comparator: Blood clot; Immediately after the extractions, the other side socket was naturally filled with blood clot.	Other: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of bone formation	During the postoperative interval of 30 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	30 days after extraction and treatment application
Fractal dimension	During the postoperative interval of 30 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.	30 days after extraction and treatment application
Dimensional Alveolar changes	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.	30 to 90 days after extraction and treatment application
Percentage of bone formation	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	90 days after extraction and treatment application
Fractal dimension	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.	90 days after extraction and treatment application

Collaborators and Investigators

• Sponsor: Federal University of Minas Gerais
• Investigators: Study Director: Anderson Ferreira, Professor, Instituto de Ciências Biológicas - Universidade Federal de Minas Gerais

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: March 8, 2016
• First Submitted That Met QC Criteria: March 15, 2016
• First Posted (Estimate): March 16, 2016

Study Record Updates

• Last Update Posted (Estimate): March 16, 2016
• Last Update Submitted That Met QC Criteria: March 15, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: hyaluronic acid; cone beam computed tomography; bone repair; dental socket
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Bone Diseases; Periodontal Atrophy; Bone Resorption; Alveolar Bone Loss; Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: CAAE: 0328.0.203.000-10