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

NCT02709525 | Completed Phase 1

• 1 other identifier: CAAE: 0328.0.203.000-10
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Alveolar Bone Loss

Keywords

hyaluronic acid; bone repair; dental socket; cone beam computed tomography

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

hyaluronic acid

EXPERIMENTAL

Immediately after the extractions, one socket was randomly filled with 1% hyaluronic acid gel.

Drug: hyaluronic acid

Blood clot

PLACEBO COMPARATOR

Immediately after the extractions, the other side socket was naturally filled with blood clot.

Other: Placebo

Interventions

hyaluronic acid DRUG

Also known as: Hyaluronan, Sodium hyaluronate

hyaluronic acid

Placebo OTHER

Blood clot

Eligibility Criteria

• Age: 14 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Orthodontic need for bilateral extraction of lower first premolars

You may not qualify if:

• 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;

Sponsors & Collaborators

• Federal University of Minas Gerais: lead

MeSH Terms

Conditions

Alveolar Bone Loss

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Anderson Ferreira, Professor

  Instituto de Ciências Biológicas - Universidade Federal de Minas Gerais

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc,PhD Student, Professor

Study Record Dates

• First Submitted: March 8, 2016
• First Posted: March 16, 2016
• Study Start: July 1, 2012
• Primary Completion: July 1, 2015
• Study Completion: March 1, 2016
• Last Updated: March 16, 2016

Record last verified: 2016-03