Back to resultsUse of Hyaluronic Acid as a Therapeutic Strategy for Bone Repair in Human
Primary Purpose
Alveolar Bone Loss
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
hyaluronic acid
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Alveolar Bone Loss focused on measuring hyaluronic acid, bone repair, dental socket, cone beam computed tomography
Eligibility Criteria
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;
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
hyaluronic acid
Blood clot
Arm Description
Immediately after the extractions, one socket was randomly filled with 1% hyaluronic acid gel.
Immediately after the extractions, the other side socket was naturally filled with blood clot.
Outcomes
Primary Outcome Measures
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
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.
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.
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
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02709525
First Posted
March 8, 2016
Last Updated
March 15, 2016
Sponsor
Federal University of Minas Gerais
1. Study Identification
Unique Protocol Identification Number
NCT02709525
Brief Title
Use of Hyaluronic Acid as a Therapeutic Strategy for Bone Repair in Human
Official Title
Use of Hyaluronic Acid as a Therapeutic Strategy for Bone Repair in Human: a Split-mouth Randomized Triple-blind Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Minas Gerais
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alveolar Bone Loss
Keywords
hyaluronic acid, bone repair, dental socket, cone beam computed tomography
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
hyaluronic acid
Arm Type
Experimental
Arm Description
Immediately after the extractions, one socket was randomly filled with 1% hyaluronic acid gel.
Arm Title
Blood clot
Arm Type
Placebo Comparator
Arm Description
Immediately after the extractions, the other side socket was naturally filled with blood clot.
Intervention Type
Drug
Intervention Name(s)
hyaluronic acid
Other Intervention Name(s)
Hyaluronan, Sodium hyaluronate
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Percentage of bone formation
Description
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
Time Frame
30 days after extraction and treatment application
Title
Fractal dimension
Description
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.
Time Frame
30 days after extraction and treatment application
Title
Dimensional Alveolar changes
Description
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.
Time Frame
30 to 90 days after extraction and treatment application
Title
Percentage of bone formation
Description
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
Time Frame
90 days after extraction and treatment application
Title
Fractal dimension
Description
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.
Time Frame
90 days after extraction and treatment application
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anderson Ferreira, Professor
Organizational Affiliation
Instituto de Ciências Biológicas - Universidade Federal de Minas Gerais
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Use of Hyaluronic Acid as a Therapeutic Strategy for Bone Repair in Human
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