Alveolar Bone LossPhase 1/2NCT02709525
Use of Hyaluronic Acid as a Therapeutic Strategy for Bone Repair in Human
A Phase 1/2 study testing hyaluronic acid in people with Alveolar Bone Loss, run by Federal University of Minas Gerais.
Trial summary
The aim of this study is to evaluate the effects of hyaluronic acid (HA) on bone healing in human dental sockets. Read more about this study
- Who is it for?
- Ages 14 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Alveolar Bone Loss
- What is being tested?
- hyaluronic acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Jul 2012to Mar 2016
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Orthodontic need for bilateral extraction of lower first premolars
Who cannot join
- 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;
About this study
Official title: 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.
- Conditions
- Alveolar Bone Loss
- Being tested
- hyaluronic acid, Placebo
- Keywords
- hyaluronic acid, bone repair, dental socket, cone beam computed tomography
- Medical subject headings
- Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hyaluronic acidDrug
Also called Hyaluronan, Sodium hyaluronate
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| hyaluronic acid | Experimental | Immediately after the extractions, one socket was randomly filled with 1% hyaluronic acid gel. Receives: Drug: hyaluronic acid |
| Blood clot | Placebo comparator | Immediately after the extractions, the other side socket was naturally filled with blood clot. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 90 days after extraction and treatment application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2016 (estimated)
- Study startJul 2012
- Primary completionJul 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Bone LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Eduardo Pinto de Alcântara, Federal University of Minas Gerais
- Investigators
- Anderson Ferreira, Professor, Study director, Instituto de Ciências Biológicas - Universidade Federal de Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02709525
- Sponsor's protocol ID
- CAAE: 0328.0.203.000-10
- Status last verified
- Mar 2016
- First submitted
- 8 Mar 2016
- Last updated
- 16 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Hyaluronic Acid as a Therapeutic Strategy for Bone Repair in Human: a Split-mouth Randomized Triple-blind Clinical Trial
- ClinicalTrials.gov ID
- NCT02709525
- Acronym / sponsor ID
- CAAE: 0328.0.203.000-10
- Conditions
- Alveolar Bone Loss
- Keywords
- hyaluronic acid, bone repair, dental socket, cone beam computed tomography
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Jul 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 16 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate the effects of hyaluronic acid (HA) on bone healing in human dental sockets.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hyaluronic acid | Experimental | Drug: hyaluronic acidImmediately after the extractions, one socket was randomly filled with 1% hyaluronic acid gel. |
| Blood clot | Placebo comparator | Other: PlaceboImmediately after the extractions, the other side socket was naturally filled with blood clot. |
Who may qualify
- Ages
- 14 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Orthodontic need for bilateral extraction of lower first premolars
Key exclusion criteria (1 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hyaluronic acidAlso: Hyaluronan, Sodium hyaluronate | Drug | hyaluronic acid |
| Placebo | Other | Blood clot |
Primary outcome
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
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.
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.
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anderson Ferreira, Professor study director
Instituto de Ciências Biológicas - Universidade Federal de Minas Gerais
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing hyaluronic acid in people with Alveolar Bone Loss, run by Federal University of Minas Gerais.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of bone formation (time frame: 30 days after extraction and treatment application). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2016.