Cyanoacrylate Use in Free Gingival Graft

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.

Study Overview

• Status: Completed
• Conditions: Gingival Recession, Localized
• Intervention / Treatment: Procedure: Free gingival graft; Procedure: Cyanoacrylate; Procedure: Suture

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34010
    • Biruni University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Biruni University
• Investigators: Principal Investigator: Mustafa YILMAZ, PhD, Biruni University, assistant professor

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Actual): June 30, 2020
• Study Completion (Actual): January 30, 2021

Study Registration Dates

• First Submitted: April 19, 2021
• First Submitted That Met QC Criteria: April 19, 2021
• First Posted (Actual): April 22, 2021

Study Record Updates

• Last Update Posted (Actual): April 29, 2021
• Last Update Submitted That Met QC Criteria: April 27, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Periodontal Atrophy; Gingival Recession
• Other Study ID Numbers: CAFGG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD will be shared
• IPD Sharing Time Frame: one year after the publication
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No