Back to resultsCyanoacrylate Use in Free Gingival Graft
Primary Purpose
Gingival Recession, Localized
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Free gingival graft
Cyanoacrylate
Suture
Sponsored by
About this trial
This is an interventional treatment trial for Gingival Recession, Localized
Eligibility Criteria
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
Sites / Locations
- Biruni University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cyanoacrylate
Suture
Arm Description
The graft is stabilized and the donor site is coated with cyanoacrylate.
6/0 polyvinylidene fluoride sutures are used for stabilization, while the donor site is left untreated.
Outcomes
Primary Outcome Measures
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
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
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
Post-operative pain
Visual analogue scale (VAS) (0-10), self-reported outcome 0 - no pain (min.) 10 - unbearable (max.)
Post-operative pain
Visual analogue scale (VAS) (0-10), self-reported outcome 0 - no pain (min.) 10 - unbearable (max.)
Post-operative pain
Visual analogue scale (VAS) (0-10), self-reported outcome 0 - no pain (min.) 10 - unbearable (max.)
Post-operative pain
Visual analogue scale (VAS) (0-10), self-reported outcome 0 - no pain (min.) 10 - unbearable (max.)
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
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
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
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
Graft dimensions
Mesio-distal (horizontal) and apico-coronal (vertical) width of the graft is measured with a periodontal probe, rounding to the nearest mm
Graft dimensions
Mesio-distal (horizontal) and apico-coronal (vertical) width of the graft is measured with a periodontal probe, rounding to the nearest mm
Graft dimensions
Mesio-distal (horizontal) and apico-coronal (vertical) width of the graft is measured with a periodontal probe, rounding to the nearest mm
Secondary Outcome Measures
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
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
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
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
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
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04854902
Brief Title
Cyanoacrylate Use in Free Gingival Graft
Official Title
The Effects of Cyanoacrylate on Self-reported Outcomes and Healing Following Free Gingival Graft Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
January 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Biruni University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession, Localized
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cyanoacrylate
Arm Type
Experimental
Arm Description
The graft is stabilized and the donor site is coated with cyanoacrylate.
Arm Title
Suture
Arm Type
Active Comparator
Arm Description
6/0 polyvinylidene fluoride sutures are used for stabilization, while the donor site is left untreated.
Intervention Type
Procedure
Intervention Name(s)
Free gingival graft
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Cyanoacrylate
Intervention Description
N-Butyl-Cyanoacryle is applied to stabilize the graft to the recipient bed and to coat the donor site wound
Intervention Type
Procedure
Intervention Name(s)
Suture
Intervention Description
The graft is stabilized with 6/0 polyvinylidene fluoride suture to the recipient bed
Primary Outcome Measure Information:
Title
Re-epithelization
Description
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
Time Frame
one week after the surgery
Title
Re-epithelization
Description
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
Time Frame
two weeks after the surgery
Title
Re-epithelization
Description
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
Time Frame
three weeks after the surgery
Title
Post-operative pain
Description
Visual analogue scale (VAS) (0-10), self-reported outcome 0 - no pain (min.) 10 - unbearable (max.)
Time Frame
1st week
Title
Post-operative pain
Description
Visual analogue scale (VAS) (0-10), self-reported outcome 0 - no pain (min.) 10 - unbearable (max.)
Time Frame
2nd week
Title
Post-operative pain
Description
Visual analogue scale (VAS) (0-10), self-reported outcome 0 - no pain (min.) 10 - unbearable (max.)
Time Frame
3rd week
Title
Post-operative pain
Description
Visual analogue scale (VAS) (0-10), self-reported outcome 0 - no pain (min.) 10 - unbearable (max.)
Time Frame
4th week
Title
Oral health impact profile (OHIP-14)
Description
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
Time Frame
Baseline
Title
Oral health impact profile (OHIP-14)
Description
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
Time Frame
3rd day
Title
Oral health impact profile (OHIP-14)
Description
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
Time Frame
1st week
Title
Oral health impact profile (OHIP-14)
Description
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
Time Frame
1st month
Title
Graft dimensions
Description
Mesio-distal (horizontal) and apico-coronal (vertical) width of the graft is measured with a periodontal probe, rounding to the nearest mm
Time Frame
1st month
Title
Graft dimensions
Description
Mesio-distal (horizontal) and apico-coronal (vertical) width of the graft is measured with a periodontal probe, rounding to the nearest mm
Time Frame
3rd month
Title
Graft dimensions
Description
Mesio-distal (horizontal) and apico-coronal (vertical) width of the graft is measured with a periodontal probe, rounding to the nearest mm
Time Frame
6th month
Secondary Outcome Measure Information:
Title
Mucosal thickness
Description
15 endodontic reamer is inserted to the palatal mucosa 5 mm apical of the gingival margin of the second premolar; under local anesthesia
Time Frame
In the beginning of the surgery (baseline)
Title
Paresthesia / hyperesthesia in the donor site
Description
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
Time Frame
1st month
Title
Color harmony
Description
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
Time Frame
1st week
Title
Color harmony
Description
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
Time Frame
2nd week
Title
Color harmony
Description
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
Time Frame
1st month
Title
Color harmony
Description
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
Time Frame
3rd month
Title
Color harmony
Description
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
Time Frame
6th month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mustafa YILMAZ, PhD
Organizational Affiliation
Biruni University, assistant professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Biruni University
City
Istanbul
ZIP/Postal Code
34010
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
All IPD will be shared
IPD Sharing Time Frame
one year after the publication
Learn more about this trial
Cyanoacrylate Use in Free Gingival Graft
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