Cyanoacrylate Use in Free Gingival Graft

Gingival Recession, Localized Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04854902
• Other study ID #: CAFGG
• Status: Completed
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: January 30, 2021

Study information

• Verified date: April 2021
• Source: Biruni University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: January 30, 2021
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gingival Recession
• Gingival Recession, Localized

Intervention

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
• Cyanoacrylate
N-Butyl-Cyanoacryle is applied to stabilize the graft to the recipient bed and to coat the donor site wound
• Suture
The graft is stabilized with 6/0 polyvinylidene fluoride suture to the recipient bed

Locations

Country	Name	City	State
Turkey	Biruni University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Biruni University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Post-operative pain	Visual analogue scale (VAS) (0-10), self-reported outcome 0 - no pain (min.) 10 - unbearable (max.)	1st week
Primary	Post-operative pain	Visual analogue scale (VAS) (0-10), self-reported outcome 0 - no pain (min.) 10 - unbearable (max.)	2nd week
Primary	Post-operative pain	Visual analogue scale (VAS) (0-10), self-reported outcome 0 - no pain (min.) 10 - unbearable (max.)	3rd week
Primary	Post-operative pain	Visual analogue scale (VAS) (0-10), self-reported outcome 0 - no pain (min.) 10 - unbearable (max.)	4th week
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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