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Completed

NCT Number: NCT02709525

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

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

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Key information

Conditions

Alveolar Bone Loss Bone Diseases Bone Resorption Mouth Diseases Musculoskeletal Diseases Periodontal Atrophy Periodontal Diseases Stomatognathic Diseases

Age range

14 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Who can participate

Healthy volunteers accepted: Yes

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

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;

Treatment and study plan

Hyaluronic acid

Drug

Other names: Hyaluronan, Sodium hyaluronate

Placebo

Other

Primary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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

  5. 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.

Sponsors and collaborators

Lead sponsor

Federal University of Minas Gerais

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
First posted
Mar 16, 2016
Registry last updated
Mar 16, 2016

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.

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