Cyanoacrylate Use in Free Gingival Graft

Study Overview
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Brief Summary
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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.

Official Title
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The Effects of Cyanoacrylate on Self-reported Outcomes and Healing Following Free Gingival Graft Surgery

Conditions
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Gingival Recession, Localized

Intervention / Treatment
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* Procedure: Free gingival graft
* Procedure: Cyanoacrylate
* Procedure: Suture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Single-tooth gingival recession in the anterior mandibular region Pain with chewing or oral hygiene practice Ongoing recession Exclusion Criteria: Systemic disease Smoking Pregnancy / lactation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cyanoacrylate<br>The graft is stabilized and the donor site is coated with cyanoacrylate. | Procedure: Free gingival graft<br>* 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<br>Procedure: Cyanoacrylate<br>* N-Butyl-Cyanoacryle is applied to stabilize the graft to the recipient bed and to coat the donor site wound<br>|
| Active Comparator: Suture<br>6/0 polyvinylidene fluoride sutures are used for stabilization, while the donor site is left untreated. | Procedure: Free gingival graft<br>* 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<br>Procedure: Suture<br>* The graft is stabilized with 6/0 polyvinylidene fluoride suture to the recipient bed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | three weeks after the surgery | 
| Post-operative pain | Visual analogue scale (VAS) (0-10), self-reported outcome 0 - no pain (min.) 10 - unbearable (max.) | 1st week | 
| Post-operative pain | Visual analogue scale (VAS) (0-10), self-reported outcome 0 - no pain (min.) 10 - unbearable (max.) | 2nd week | 
| Post-operative pain | Visual analogue scale (VAS) (0-10), self-reported outcome 0 - no pain (min.) 10 - unbearable (max.) | 3rd week | 
| Post-operative pain | Visual analogue scale (VAS) (0-10), self-reported outcome 0 - no pain (min.) 10 - unbearable (max.) | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 6th month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 6th month |