NCT04854902

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 19, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 22, 2021

Completed
Last Updated

April 29, 2021

Status Verified

April 1, 2021

Enrollment Period

1.8 years

First QC Date

April 19, 2021

Last Update Submit

April 27, 2021

Conditions

Gingival Recession, Localized

Outcome Measures

Primary Outcomes (14)

  • 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 Outcomes (7)

  • Mucosal thickness

    In the beginning of the surgery (baseline)

  • Paresthesia / hyperesthesia in the donor site

    1st month

  • Color harmony

    1st week

  • Color harmony

    2nd week

  • Color harmony

    1st month

  • +2 more secondary outcomes

Study Arms (2)

Cyanoacrylate

EXPERIMENTAL

The graft is stabilized and the donor site is coated with cyanoacrylate.

Procedure: Free gingival graftProcedure: Cyanoacrylate

Suture

ACTIVE COMPARATOR

6/0 polyvinylidene fluoride sutures are used for stabilization, while the donor site is left untreated.

Procedure: Free gingival graftProcedure: Suture

Interventions

Free gingival graftPROCEDURE

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

CyanoacrylateSuture
CyanoacrylatePROCEDURE

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

Cyanoacrylate
SuturePROCEDURE

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

Suture

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Single-tooth gingival recession in the anterior mandibular region
  • Pain with chewing or oral hygiene practice
  • Ongoing recession

You may not qualify if:

  • Systemic disease
  • Smoking
  • Pregnancy / lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biruni University

Istanbul, 34010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Gingival Recession

Interventions

CyanoacrylatesSutures

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Intervention Hierarchy (Ancestors)

AcrylatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsNitrilesPolymersMacromolecular SubstancesBiomedical and Dental MaterialsTissue AdhesivesManufactured MaterialsTechnology, Industry, and AgricultureSurgical Fixation DevicesSurgical EquipmentEquipment and Supplies

Study Officials

  • Mustafa YILMAZ, PhD

    Biruni University, assistant professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 19, 2021

First Posted

April 22, 2021

Study Start

September 1, 2018

Primary Completion

June 30, 2020

Study Completion

January 30, 2021

Last Updated

April 29, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will share

All IPD will be shared

Shared Documents
STUDY PROTOCOL
Time Frame
one year after the publication

Locations

TU(1)