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

Overview

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

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: July 2015

Interventions

  • Drug: hyaluronic acid
  • Other: Placebo

Arms, Groups and Cohorts

  • Experimental: hyaluronic acid
    • Immediately after the extractions, one socket was randomly filled with 1% hyaluronic acid gel.
  • Placebo Comparator: Blood clot
    • Immediately after the extractions, the other side socket was naturally filled with blood clot.

Clinical Trial Outcome Measures

Primary Measures

  • Percentage of bone formation
    • Time Frame: 30 days after extraction and treatment application
    • 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
  • Fractal dimension
    • Time Frame: 30 days after extraction and treatment application
    • 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.
  • Dimensional Alveolar changes
    • Time Frame: 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
    • Time Frame: 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
  • Fractal dimension
    • Time Frame: 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.

Participating in This Clinical Trial

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;

Gender Eligibility: All

Minimum Age: 14 Years

Maximum Age: 40 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Federal University of Minas Gerais
  • Provider of Information About this Clinical Study
    • Principal Investigator: Carlos Eduardo Pinto de Alcântara, MSc,PhD Student, Professor – Federal University of Minas Gerais
  • Overall Official(s)
    • Anderson Ferreira, Professor, Study Director, Instituto de Ciências Biológicas – Universidade Federal de Minas Gerais

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