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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04854902
Other study ID # CAFGG
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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