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

Sponsor

Federal University of Minas Gerais (Other)

Overall Status

Completed

CT.gov ID

NCT02709525

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Alveolar Bone Loss	Drug: hyaluronic acid Other: Placebo	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 2012

Actual Primary Completion Date :

Jul 1, 2015

Actual Study Completion Date :

Mar 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: hyaluronic acid Immediately after the extractions, one socket was randomly filled with 1% hyaluronic acid gel.	Drug: hyaluronic acid Other Names: Hyaluronan Sodium hyaluronate
Placebo Comparator: Blood clot Immediately after the extractions, the other side socket was naturally filled with blood clot.	Other: Placebo

Arm

Intervention/Treatment

Experimental: hyaluronic acid

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

Drug: hyaluronic acid

Other Names:

Hyaluronan

Sodium hyaluronate

Placebo Comparator: Blood clot

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

Other: Placebo

Outcome Measures

Primary Outcome Measures

Percentage of bone formation [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 [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 [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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;