NCT07706257

Brief Summary

The purpose of this retrospective clinical study is to compare the long-term aesthetic integration and clinical outcomes of two periodontal plastic surgery techniques: Gingival Unit Grafting (GUG) and Free Gingival Grafting (FGG). The study evaluates the effectiveness of these procedures in increasing keratinized tissue width and assesses the color integration of the grafted tissues with the surrounding gingiva over an 18-month follow-up period using objective digital color analysis based on CIE Lab and RGB parameters.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2022

Typical duration for all trials

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

March 1, 2022

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 11, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 15, 2026

Completed
Last Updated

July 16, 2026

Status Verified

July 1, 2026

Enrollment Period

2.3 years

First QC Date

July 11, 2026

Last Update Submit

July 15, 2026

Conditions

Gingival Recession, Mucogingival SurgeryKeratinized Tissue Deficiency

Keywords

Gingival Unit GraftFree Gingival GraftAestheticsDigital color analysisColor matching

Outcome Measures

Primary Outcomes (1)

  • Aesthetic Integration (Color Evaluation)

    Objective assessment of color integration between the grafted tissue and the surrounding gingiva using digital color analysis. Color parameters were evaluated based on the CIE Lab\* color space system and RGB color channels obtained from standardized clinical photographs. The degree of color matching between grafted and adjacent tissues was assessed over the follow-up period.

    Baseline and 18 months post-surgery

Secondary Outcomes (1)

  • Keratinized Tissue Width (KTW)

    Baseline and 18 months post-surgery

Study Arms (2)

Gingival Unit Graft (GUG) Group

Patients who underwent periodontal plastic surgery using Gingival Unit Grafts for keratinized tissue gain

Procedure: Gingival Unit Grafting

Conventional Free Gingival Graft (FGG) Group

Patients who underwent periodontal plastic surgery using Conventional Free Gingival Grafts for keratinized tissue gain

Procedure: Conventional Free Gingival Grafting

Interventions

Gingival Unit GraftingPROCEDURE

Harvesting a gingival unit graft and transplanting it to the recipient area to increase keratinized tissue width and assess long-term aesthetic integration.

Gingival Unit Graft (GUG) Group
Conventional Free Gingival GraftingPROCEDURE

Harvesting a conventional free gingival graft and transplanting it to the recipient area to increase keratinized tissue width and serve as a control group for aesthetic integration.

Conventional Free Gingival Graft (FGG) Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consists of adult patients seeking treatment for localized gingival recessions on mandibular incisors at a university faculty of dentistry.

You may qualify if:

  • Systemically healthy individuals aged between 18 and 65 years
  • No systemic diseases contraindicating periodontal surgery
  • Not taking medications known to exert adverse effects on periodontal tissues
  • Presenting with Cairo Type 2 (RT2) or Type 3 (RT3) localized gingival recessions on mandibular incisors
  • Presence of ≤1 mm of attached gingiva resulting in difficulty maintaining plaque control
  • Full-mouth plaque and gingival index scores ≤1
  • Bleeding on probing (BOP) \<10%
  • No history of prior soft tissue surgery in the designated area

You may not qualify if:

  • Individuals who are pregnant or lactating.
  • Presenting with gingival recession or prosthetic restorations at the donor site (maxillary premolar palatal region).
  • Cases demonstrating caries, abrasions, or restorations on the root surfaces of the related teeth.
  • Individuals with known allergies to dental impression materials.
  • Periodontal pocket depth greater than 3 mm.
  • Tooth malposition.
  • Endodontic complications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem Vakif University, Faculty of Dentistry

Istanbul, Fatih, 34093, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer, DDS, PhD

Study Record Dates

First Submitted

July 11, 2026

First Posted

July 15, 2026

Study Start

March 1, 2022

Primary Completion

June 30, 2024

Study Completion

December 31, 2024

Last Updated

July 16, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)