NCT07359300

Brief Summary

This randomized controlled clinical trial evaluated the effectiveness of butyl-cyanoacrylate tissue adhesive compared with conventional sutures for stabilization of free gingival grafts. Twenty-four patients with insufficient keratinized tissue were randomly assigned to either cyanoacrylate or suture stabilization following free gingival graft surgery. Clinical parameters, graft dimensional changes, patient-reported postoperative discomfort, and operative time were assessed over a 6-month follow-up period.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2019

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2019

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

January 14, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 22, 2026

Completed
Last Updated

January 22, 2026

Status Verified

January 1, 2026

Enrollment Period

2.2 years

First QC Date

January 14, 2026

Last Update Submit

January 14, 2026

Conditions

Gingival RecessionMucogingival DefectsInsufficient Keratinized Tissue

Keywords

Free gingival graftCyanoacrylateSuturesKeratinized tissueRandomized clinical trial

Outcome Measures

Primary Outcomes (1)

  • Change in Keratinized Tissue Width

    Change in keratinized tissue width measured at the surgical sites using a periodontal probe.

    Baseline and 6 months postoperatively

Secondary Outcomes (8)

  • Total Graft Surface Area (TGSA)

    Baseline, 1 month, 3 months, and 6 months postoperatively

  • Vertical Graft Height (VGH)

    Baseline, 1 month, 3 months, and 6 months postoperatively

  • Probing Depth (PD)

    Baseline and 6 months postoperatively

  • Vertical Recession (VR)

    Baseline and 6 months postoperatively

  • Full-Mouth Plaque Score (FMPS)

    Baseline and 6 months postoperatively

  • +3 more secondary outcomes

Study Arms (2)

Cyanoacrylate Stabilization Group

EXPERIMENTAL

Free gingival grafts were stabilized using butyl-cyanoacrylate tissue adhesive following standard free gingival graft surgery.

Procedure: Free Gingival Graft Stabilization With Butyl-Cyanoacrylate

Suture Stabilization Group

ACTIVE COMPARATOR

Free gingival grafts were stabilized using non-resorbable polypropylene sutures following standard free gingival graft surgery.

Procedure: Free Gingival Graft Stabilization With Sutures

Interventions

Free Gingival Graft Stabilization With Butyl-CyanoacrylatePROCEDURE

Stabilization of free gingival grafts using butyl-cyanoacrylate tissue adhesive following standard free gingival graft surgery.

Cyanoacrylate Stabilization Group
Free Gingival Graft Stabilization With SuturesPROCEDURE

Stabilization of free gingival grafts using non-resorbable polypropylene sutures following standard free gingival graft surgery.

Suture Stabilization Group

Eligibility Criteria

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

You may qualify if:

  • Adults aged 18 years or older
  • Presence of ≤1 mm of keratinized tissue and/or Miller Class I gingival recession ≤2 mm affecting one to four mandibular anterior teeth
  • Vital teeth in the surgical area
  • Good oral hygiene following initial periodontal therapy (full-mouth plaque score and full-mouth bleeding score ≤20%)
  • Ability to understand the study procedures and provide written informed consent

You may not qualify if:

  • Current smokers
  • Pregnancy or lactation
  • Use of systemic antibiotics within the previous 6 months
  • History of periodontal surgery in the study area
  • Ongoing orthodontic treatment
  • Systemic conditions that could affect periodontal healing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yeditepe University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Gingival Recession

Interventions

Sutures

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Intervention Hierarchy (Ancestors)

Surgical Fixation DevicesSurgical EquipmentEquipment and Supplies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Clinical outcome measurements were performed by an examiner blinded to group allocation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants were randomly assigned to one of two parallel groups to receive free gingival graft stabilization using either butyl-cyanoacrylate tissue adhesive or conventional sutures.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

January 14, 2026

First Posted

January 22, 2026

Study Start

June 1, 2019

Primary Completion

August 1, 2021

Study Completion

August 1, 2021

Last Updated

January 22, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)