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

Alveolar Bone Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02709525
• Other study ID #: CAAE: 0328.0.203.000-10
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 8, 2016
• Last updated: March 15, 2016
• Start date: July 2012
• Est. completion date: March 2016

Study information

• Verified date: March 2016
• Source: Federal University of Minas Gerais
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: March 2016
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 14 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alveolar Bone Loss

Intervention

Drug:
• hyaluronic acid

Other:
• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Minas Gerais

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes