Gingival RecessionNCT03273010
The Use of Cyanoacrylate on Palatal Wound
A study testing Free gingival graft and Cyanoacrylate application in people with Gingival Recession, run by Ordu University.
Trial summary
The palatal donor site of autogenous free gingival grafts significantly influences the patient's morbidity. The purpose of this study was to evaluate the efficacy of cyanoacrylate on palatal wound healing and postoperative complaints. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession
- What is being tested?
- Free gingival graft and Cyanoacrylate application
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- Dec 2015to Dec 2016
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- no systemic diseases
- no coagulation disorders
- no drug intake in the previous 6 months that might effect the periodontal health status
- no pregnancy or lactation
- no smoking habit
- <1 mm attached gingiva width on one or two lower anterior teeth
- Miller Class I- II- III (Miller 1985) with deep gingival recession (˃ 3mm)
Who cannot join
- Hematologic disorders
- No cooperation
About this study
Official title: The Efficacy of Cyanoacrylate on Palatal Wound Healing and Postoperative Complaints
The palatal donor site of autogenous free gingival grafts significantly influences the patient's morbidity. The purpose of this study was to evaluate the efficacy of cyanoacrylate on palatal wound healing and postoperative complaints.
Read the detailed description
A total of 35 patients were included in the study. In the test group (19 patient), cyanoacrylate was placed over the palatal wounds; conversely, the 16 control group patients were allowed to heal in a conventional way without cyanoacrylate.
Primary bleeding time, presence of secondary bleeding, postoperative pain and completion of epithelization were assessed following free gingival graft operation. As a result, compared to the control group it was determined that the cyanoacrylate tissue adhesive could reduce the postoperative morbidity and improve the wound healing.
- Conditions
- Gingival Recession
- Being tested
- Free gingival graft, Cyanoacrylate application
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Free gingival graftProcedure or surgery
Free gingival graft was harvested from palatal donor site
Cyanoacrylate applicationProcedure or surgery
Periacyrl was applied on palatal wounds
| Study group | Role | What they receive |
|---|---|---|
| Periacryl group | Experimental | Periacryl, a tissue adhesive, was applied on wound surfaces to achieve haemostasis Receives: Procedure: Free gingival graft; Procedure: Cyanoacrylate application |
| Control group | Active comparator | Free gingival graft was harvested from palatal region and left to heal without applying periacryl. Receives: Procedure: Free gingival graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary bleeding time
The moment of active blood flow stasis that a clinical photograph could be taken by examiner without need for suction.
Measured: baseline
Secondary outcomes (3)
Visual Analog Scale (VAS)
The changes in postoperative pain level after the operation
Measured: 1-7 days after operation
Analgesic consumption
The changes in the number of painkiller taken to relieve pain after the operation
Measured: 1-7 days after operation
Completion of epithelization
The epithelization assessed by the peroxide test
Measured: Once a week for a month after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2017
- Study startDec 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival RecessionStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ordu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ceren Gökmenoğlu, Ordu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03273010
- Sponsor's protocol ID
- Ordu Uni
- Status last verified
- Sep 2017
- First submitted
- 3 Aug 2017
- Last updated
- 6 Sep 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Cyanoacrylate on Palatal Wound Healing and Postoperative Complaints
- ClinicalTrials.gov ID
- NCT03273010
- Acronym / sponsor ID
- Ordu Uni
- Conditions
- Gingival Recession
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Ordu UniversityUniversity, hospital or other
- Study start
- Dec 2015 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 6 Sep 2017 (actual)
- 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 palatal donor site of autogenous free gingival grafts significantly influences the patient's morbidity. The purpose of this study was to evaluate the efficacy of cyanoacrylate on palatal wound healing and postoperative complaints.
Detailed description
A total of 35 patients were included in the study. In the test group (19 patient), cyanoacrylate was placed over the palatal wounds; conversely, the 16 control group patients were allowed to heal in a conventional way without cyanoacrylate.
Primary bleeding time, presence of secondary bleeding, postoperative pain and completion of epithelization were assessed following free gingival graft operation. As a result, compared to the control group it was determined that the cyanoacrylate tissue adhesive could reduce the postoperative morbidity and improve the wound healing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Periacryl group | Experimental | Procedure: Free gingival graft, Procedure: Cyanoacrylate applicationPeriacryl, a tissue adhesive, was applied on wound surfaces to achieve haemostasis |
| Control group | Active comparator | Procedure: Free gingival graftFree gingival graft was harvested from palatal region and left to heal without applying periacryl. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- no systemic diseases
- no coagulation disorders
- no drug intake in the previous 6 months that might effect the periodontal health status
- no pregnancy or lactation
- no smoking habit
Key exclusion criteria (2 listed)
- Hematologic disorders
- No cooperation
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 |
|---|---|---|
| Free gingival graftFree gingival graft was harvested from palatal donor site | Procedure or surgery | Control group, Periacryl group |
| Cyanoacrylate applicationPeriacyrl was applied on palatal wounds | Procedure or surgery | Periacryl group |
Primary outcome
Primary bleeding time
Time frame: baseline
The moment of active blood flow stasis that a clinical photograph could be taken by examiner without need for suction.
3 secondary outcomes
Visual Analog Scale (VAS)
Time frame: 1-7 days after operation
Analgesic consumption
Time frame: 1-7 days after operation
Completion of epithelization
Time frame: Once a week for a month after the operation
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 6 Sep 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Free gingival graft and Cyanoacrylate application in people with Gingival Recession, run by Ordu University.
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 7 inclusion and 2 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 6 Sep 2017. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Primary bleeding time (time frame: baseline). 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 6 Sep 2017.