- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02709525
Use of Hyaluronic Acid as a Therapeutic Strategy for Bone Repair in Human
March 15, 2016 updated by: Carlos Eduardo Pinto de Alcântara, Federal University of Minas Gerais
Use of Hyaluronic Acid as a Therapeutic Strategy for Bone Repair in Human: a Split-mouth Randomized Triple-blind Clinical Trial
The aim of this study is to evaluate the effects of hyaluronic acid (HA) on bone healing in human dental sockets.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Phase 2
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 40 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: hyaluronic acid
Immediately after the extractions, one socket was randomly filled with 1% hyaluronic acid gel.
|
Other Names:
|
Placebo Comparator: Blood clot
Immediately after the extractions, the other side socket was naturally filled with blood clot.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
30 days after extraction and treatment application
|
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.
|
30 days after extraction and treatment application
|
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.
|
30 to 90 days after extraction and treatment application
|
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
|
90 days after extraction and treatment application
|
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.
|
90 days after extraction and treatment application
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Anderson Ferreira, Professor, Instituto de Ciências Biológicas - Universidade Federal de Minas Gerais
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2012
Primary Completion (Actual)
July 1, 2015
Study Completion (Actual)
March 1, 2016
Study Registration Dates
First Submitted
March 8, 2016
First Submitted That Met QC Criteria
March 15, 2016
First Posted (Estimate)
March 16, 2016
Study Record Updates
Last Update Posted (Estimate)
March 16, 2016
Last Update Submitted That Met QC Criteria
March 15, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CAAE: 0328.0.203.000-10
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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