Gingival Recession, LocalizedNCT04854902
Cyanoacrylate Use in Free Gingival Graft
A study testing Free gingival graft, Cyanoacrylate and Suture in people with Gingival Recession, Localized, run by Biruni University at 1 site in Turkey (Türkiye).
Trial summary
Present study aims to reveal the effects of cyanoacrylate application at the recipient bed and the donor site in free gingival graft surgery on the healing parameters and patient-based outcomes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession, Localized
- What is being tested?
- Free gingival graft, Cyanoacrylate and Suture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2018to 30 Jan 2021
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Single-tooth gingival recession in the anterior mandibular region
- Pain with chewing or oral hygiene practice
- Ongoing recession
Who cannot join
- Systemic disease
- Smoking
- Pregnancy / lactation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Cyanoacrylate on Self-reported Outcomes and Healing Following Free Gingival Graft Surgery
Present study aims to reveal the effects of cyanoacrylate application at the recipient bed and the donor site in free gingival graft surgery on the healing parameters and patient-based outcomes.
- Conditions
- Gingival Recession, Localized
- Being tested
- Free gingival graft, Cyanoacrylate, Suture
- 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
1.5-2 x 5 x 10 mm size epithelialized graft harvested from the palate is stabilized in the mandibular anterior single-tooth recession region
CyanoacrylateProcedure or surgery
N-Butyl-Cyanoacryle is applied to stabilize the graft to the recipient bed and to coat the donor site wound
SutureProcedure or surgery
The graft is stabilized with 6/0 polyvinylidene fluoride suture to the recipient bed
| Study group | Role | What they receive |
|---|---|---|
| Cyanoacrylate | Experimental | The graft is stabilized and the donor site is coated with cyanoacrylate. Receives: Procedure: Free gingival graft; Procedure: Cyanoacrylate |
| Suture | Active comparator | 6/0 polyvinylidene fluoride sutures are used for stabilization, while the donor site is left untreated. Receives: Procedure: Free gingival graft; Procedure: Suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Re-epithelization
Donor site re-epithelization: hydrogen-peroxide is applied to the donor area with the help of an injector, and it is recorded as complete when no foaming occurs
Measured: one week after the surgery
Re-epithelization
Donor site re-epithelization: hydrogen-peroxide is applied to the donor area with the help of an injector, and it is recorded as complete when no foaming occurs
Measured: two weeks after the surgery
Re-epithelization
Donor site re-epithelization: hydrogen-peroxide is applied to the donor area with the help of an injector, and it is recorded as complete when no foaming occurs
Measured: three weeks after the surgery
Post-operative pain
Visual analogue scale (VAS) (0-10), self-reported outcome 0 - no pain (min.) 10 - unbearable (max.)
Measured: 1st week
Post-operative pain
Visual analogue scale (VAS) (0-10), self-reported outcome 0 - no pain (min.) 10 - unbearable (max.)
Measured: 2nd week
Post-operative pain
Visual analogue scale (VAS) (0-10), self-reported outcome 0 - no pain (min.) 10 - unbearable (max.)
Measured: 3rd week
Post-operative pain
Visual analogue scale (VAS) (0-10), self-reported outcome 0 - no pain (min.) 10 - unbearable (max.)
Measured: 4th week
Oral health impact profile (OHIP-14)
The patients are asked to fill provided OHIP-14 forms Questionnaire about satisfaction related to oral health, scored as 0-4 (never - always) 14 questions in total 0 (min.) - 56 (max.) Lower scores represent higher oral health related life quality
Measured: Baseline
Oral health impact profile (OHIP-14)
The patients are asked to fill provided OHIP-14 forms Questionnaire about satisfaction related to oral health, scored as 0-4 (never - always) 14 questions in total 0 (min.) - 56 (max.) Lower scores represent higher oral health related life quality
Measured: 3rd day
Oral health impact profile (OHIP-14)
The patients are asked to fill provided OHIP-14 forms Questionnaire about satisfaction related to oral health, scored as 0-4 (never - always) 14 questions in total 0 (min.) - 56 (max.) Lower scores represent higher oral health related life quality
Measured: 1st week
Oral health impact profile (OHIP-14)
The patients are asked to fill provided OHIP-14 forms Questionnaire about satisfaction related to oral health, scored as 0-4 (never - always) 14 questions in total 0 (min.) - 56 (max.) Lower scores represent higher oral health related life quality
Measured: 1st month
Graft dimensions
Mesio-distal (horizontal) and apico-coronal (vertical) width of the graft is measured with a periodontal probe, rounding to the nearest mm
Measured: 1st month
Graft dimensions
Mesio-distal (horizontal) and apico-coronal (vertical) width of the graft is measured with a periodontal probe, rounding to the nearest mm
Measured: 3rd month
Graft dimensions
Mesio-distal (horizontal) and apico-coronal (vertical) width of the graft is measured with a periodontal probe, rounding to the nearest mm
Measured: 6th month
Secondary outcomes (7)
Mucosal thickness
15 endodontic reamer is inserted to the palatal mucosa 5 mm apical of the gingival margin of the second premolar; under local anesthesia
Measured: In the beginning of the surgery (baseline)
Paresthesia / hyperesthesia in the donor site
The patient marks the visual analogue scale (0-10) after rubbing the donor site with a periodontal probe (to give a reference, symmetrical area is rubbed first) 0 - Paresthesia / hyperesthesia, 10 - no sensation difference with the reference area
Measured: 1st month
Color harmony
Color harmony between the graft and the neighboring keratinized tissue at the recipient site, examiner gives a score ranging 0-10 0 - completely different tone/color of the graft; 10 - no detectible tone difference
Measured: 1st week
Color harmony
Color harmony between the graft and the neighboring keratinized tissue at the recipient site, examiner gives a score ranging 0-10 0 - completely different tone/color of the graft; 10 - no detectible tone difference
Measured: 2nd week
Color harmony
Color harmony between the graft and the neighboring keratinized tissue at the recipient site, examiner gives a score ranging 0-10 0 - completely different tone/color of the graft; 10 - no detectible tone difference
Measured: 1st month
Color harmony
Color harmony between the graft and the neighboring keratinized tissue at the recipient site, examiner gives a score ranging 0-10 0 - completely different tone/color of the graft; 10 - no detectible tone difference
Measured: 3rd month
Color harmony
Color harmony between the graft and the neighboring keratinized tissue at the recipient site, examiner gives a score ranging 0-10 0 - completely different tone/color of the graft; 10 - no detectible tone difference
Measured: 6th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
- Study start1 Sep 2018
- Primary completion30 Jun 2020
- Study completion30 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival Recession, LocalizedStudies of the same condition, open and under way.
- More trials run by Biruni UniversityThe sponsor's other registered studies.
- 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
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa YILMAZ, Biruni University
- Investigators
- Mustafa YILMAZ, PhD, Principal investigator, Biruni University, assistant professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04854902
- Sponsor's protocol ID
- CAFGG
- Status last verified
- Apr 2021
- First submitted
- 19 Apr 2021
- Last updated
- 29 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD will be shared
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Cyanoacrylate on Self-reported Outcomes and Healing Following Free Gingival Graft Surgery
- ClinicalTrials.gov ID
- NCT04854902
- Acronym / sponsor ID
- CAFGG
- Conditions
- Gingival Recession, Localized
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jan 2021 (actual)
- First posted
- 22 Apr 2021 (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.
Present study aims to reveal the effects of cyanoacrylate application at the recipient bed and the donor site in free gingival graft surgery on the healing parameters and patient-based outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cyanoacrylate | Experimental | Procedure: Free gingival graft, Procedure: CyanoacrylateThe graft is stabilized and the donor site is coated with cyanoacrylate. |
| Suture | Active comparator | Procedure: Free gingival graft, Procedure: Suture6/0 polyvinylidene fluoride sutures are used for stabilization, while the donor site is left untreated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Single-tooth gingival recession in the anterior mandibular region
- Pain with chewing or oral hygiene practice
- Ongoing recession
Key exclusion criteria (3 listed)
- Systemic disease
- Smoking
- Pregnancy / lactation
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 graft1.5-2 x 5 x 10 mm size epithelialized graft harvested from the palate is stabilized in the mandibular anterior single-tooth recession region | Procedure or surgery | Cyanoacrylate, Suture |
| CyanoacrylateN-Butyl-Cyanoacryle is applied to stabilize the graft to the recipient bed and to coat the donor site wound | Procedure or surgery | Cyanoacrylate |
| SutureThe graft is stabilized with 6/0 polyvinylidene fluoride suture to the recipient bed | Procedure or surgery | Suture |
Primary outcome
Re-epithelization
Time frame: one week after the surgery
Donor site re-epithelization: hydrogen-peroxide is applied to the donor area with the help of an injector, and it is recorded as complete when no foaming occurs
Re-epithelization
Time frame: two weeks after the surgery
Donor site re-epithelization: hydrogen-peroxide is applied to the donor area with the help of an injector, and it is recorded as complete when no foaming occurs
Re-epithelization
Time frame: three weeks after the surgery
Donor site re-epithelization: hydrogen-peroxide is applied to the donor area with the help of an injector, and it is recorded as complete when no foaming occurs
Post-operative pain
Time frame: 1st week
Visual analogue scale (VAS) (0-10), self-reported outcome 0 - no pain (min.) 10 - unbearable (max.)
Post-operative pain
Time frame: 2nd week
Visual analogue scale (VAS) (0-10), self-reported outcome 0 - no pain (min.) 10 - unbearable (max.)
Post-operative pain
Time frame: 3rd week
Visual analogue scale (VAS) (0-10), self-reported outcome 0 - no pain (min.) 10 - unbearable (max.)
Post-operative pain
Time frame: 4th week
Visual analogue scale (VAS) (0-10), self-reported outcome 0 - no pain (min.) 10 - unbearable (max.)
Oral health impact profile (OHIP-14)
Time frame: Baseline
The patients are asked to fill provided OHIP-14 forms Questionnaire about satisfaction related to oral health, scored as 0-4 (never - always) 14 questions in total 0 (min.) - 56 (max.) Lower scores represent higher oral health related life quality
Oral health impact profile (OHIP-14)
Time frame: 3rd day
The patients are asked to fill provided OHIP-14 forms Questionnaire about satisfaction related to oral health, scored as 0-4 (never - always) 14 questions in total 0 (min.) - 56 (max.) Lower scores represent higher oral health related life quality
Oral health impact profile (OHIP-14)
Time frame: 1st week
The patients are asked to fill provided OHIP-14 forms Questionnaire about satisfaction related to oral health, scored as 0-4 (never - always) 14 questions in total 0 (min.) - 56 (max.) Lower scores represent higher oral health related life quality
Oral health impact profile (OHIP-14)
Time frame: 1st month
The patients are asked to fill provided OHIP-14 forms Questionnaire about satisfaction related to oral health, scored as 0-4 (never - always) 14 questions in total 0 (min.) - 56 (max.) Lower scores represent higher oral health related life quality
Graft dimensions
Time frame: 1st month
Mesio-distal (horizontal) and apico-coronal (vertical) width of the graft is measured with a periodontal probe, rounding to the nearest mm
Graft dimensions
Time frame: 3rd month
Mesio-distal (horizontal) and apico-coronal (vertical) width of the graft is measured with a periodontal probe, rounding to the nearest mm
Graft dimensions
Time frame: 6th month
Mesio-distal (horizontal) and apico-coronal (vertical) width of the graft is measured with a periodontal probe, rounding to the nearest mm
7 secondary outcomes
Mucosal thickness
Time frame: In the beginning of the surgery (baseline)
Paresthesia / hyperesthesia in the donor site
Time frame: 1st month
Color harmony
Time frame: 1st week
Color harmony
Time frame: 2nd week
Color harmony
Time frame: 1st month
Color harmony
Time frame: 3rd month
Color harmony
Time frame: 6th month
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 29 Apr 2021.
- Individual participant dataSharing planned: Yes. All IPD will be shared
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Palatal Wound Healing After Free Gingival Graft Harvest in Diabetic Patients: A Clinical Trial
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Evaluation of the Effect of Smoking on Palatal Donor Site Tissue Profile in the Success of Connective Tissue Grafts
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Oral Mucosa Wound Healing After Gingival Recession Treatment in Diabetic Patients. A Clinical Study.
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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.
Mustafa YILMAZ, PhD principal investigator
Biruni University, assistant professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Free gingival graft, Cyanoacrylate and Suture in people with Gingival Recession, Localized, run by Biruni University at 1 site in Turkey (Türkiye).
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 3 inclusion and 3 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 29 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Re-epithelization (time frame: one week after the surgery). The study lists 14 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 29 Apr 2021.