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

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

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

Conditions
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Alveolar Bone Loss

Intervention / Treatment
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* Drug: hyaluronic acid
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hyaluronic acid, bone repair, dental socket, cone beam computed tomography