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Completed

NCT Number: NCT04854902

Cyanoacrylate Use in Free Gingival Graft

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.

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Key information

Conditions

Gingival Recession, Localized Gingival Diseases Gingival Recession Mouth Diseases Periodontal Atrophy Periodontal Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Biruni University

Istanbul, 34010, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Free gingival graft

Procedure

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

Procedure

N-Butyl-Cyanoacryle is applied to stabilize the graft to the recipient bed and to coat the donor site wound

Suture

Procedure

The graft is stabilized with 6/0 polyvinylidene fluoride suture to the recipient bed

Primary outcomes

  1. Re-epithelization

    Time frame: one week after the surgery

    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

  2. Re-epithelization

    Time frame: two weeks after the surgery

    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

  3. Re-epithelization

    Time frame: three weeks after the surgery

    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

  4. Post-operative pain

    Time frame: 1st week

    Visual analogue scale (VAS) (0-10), self-reported outcome 0 - no pain (min.) 10 - unbearable (max.)

  5. Post-operative pain

    Time frame: 2nd week

    Visual analogue scale (VAS) (0-10), self-reported outcome 0 - no pain (min.) 10 - unbearable (max.)

  6. Post-operative pain

    Time frame: 3rd week

    Visual analogue scale (VAS) (0-10), self-reported outcome 0 - no pain (min.) 10 - unbearable (max.)

  7. Post-operative pain

    Time frame: 4th week

    Visual analogue scale (VAS) (0-10), self-reported outcome 0 - no pain (min.) 10 - unbearable (max.)

  8. Oral health impact profile (OHIP-14)

    Time frame: Baseline

    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

  9. Oral health impact profile (OHIP-14)

    Time frame: 3rd day

    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

  10. Oral health impact profile (OHIP-14)

    Time frame: 1st week

    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

  11. Oral health impact profile (OHIP-14)

    Time frame: 1st month

    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

  12. Graft dimensions

    Time frame: 1st month

    Mesio-distal (horizontal) and apico-coronal (vertical) width of the graft is measured with a periodontal probe, rounding to the nearest mm

  13. Graft dimensions

    Time frame: 3rd month

    Mesio-distal (horizontal) and apico-coronal (vertical) width of the graft is measured with a periodontal probe, rounding to the nearest mm

  14. Graft dimensions

    Time frame: 6th month

    Mesio-distal (horizontal) and apico-coronal (vertical) width of the graft is measured with a periodontal probe, rounding to the nearest mm

Secondary outcomes

  1. Mucosal thickness

    Time frame: In the beginning of the surgery (baseline)

    15 endodontic reamer is inserted to the palatal mucosa 5 mm apical of the gingival margin of the second premolar; under local anesthesia

  2. Paresthesia / hyperesthesia in the donor site

    Time frame: 1st month

    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

  3. Color harmony

    Time frame: 1st week

    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

  4. Color harmony

    Time frame: 2nd week

    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

  5. Color harmony

    Time frame: 1st month

    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

  6. Color harmony

    Time frame: 3rd month

    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

  7. Color harmony

    Time frame: 6th month

    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

Sponsors and collaborators

Lead sponsor

Biruni University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Apr 22, 2021
Registry last updated
Apr 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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