NCT07199686

Brief Summary

This study evaluates gingival color following Free Gingival Graft (FGG) surgery using polarized digital photography to objectively analyze grafted and adjacent tissues. Conventional verbal descriptors (e.g., pale pink, salmon pink) lack precision; therefore, digital colorimetry provides objective, non-contact, and reproducible measurements. The protocol utilizes the CIELab system with standardized color disks and polarization to document postoperative color changes accurately. The study objectives are: (1) to determine CIELab color values of FGG-treated gingiva in patients who underwent conventional surgery at least six months earlier; (2) to assess the influence of age, sex, time since surgery, and gingival thickness on these values; and (3) to compare graft color with adjacent gingiva. Hypothesis: In FGG-treated patients, graft CIELab color values are unaffected by age, sex, postoperative duration, or gingival thickness.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2023

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 20, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 5, 2023

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 10, 2025

Completed
20 days until next milestone

First Posted

Study publicly available on registry

September 30, 2025

Completed
Last Updated

September 30, 2025

Status Verified

September 1, 2025

Enrollment Period

5 months

First QC Date

September 10, 2025

Last Update Submit

September 22, 2025

Conditions

Keywords

CIELabDigital color analysiscross-polarized filterfree gingival graftgingiva color

Outcome Measures

Primary Outcomes (2)

  • Characterization of the color values of the Free Gingival Graft (FGG) according to the CIELab color system

    Standardized intraoral photographs were obtained from fifty participants. Digital images were obtained using a camera with standardized settings to ensure reproducibility. All images, taken with and without the filter. Photographs were analyzed in Adobe Photoshop programme using the CIELAB system. The FGG region was divided into three equal zones (coronal, middle, apical). For each region, mean L\*, a\*, and b\* values were calculated.

    Through study completion, an average of 6 months

  • Characterization of the color values of the adjacent keratinized gingiva according to the CIELab color system

    Standardized intraoral photographs were obtained from fifty participants. Digital images were obtained using a camera with standardized settings to ensure reproducibility. All images, taken with and without the filter. Photographs were analyzed in Adobe Photoshop programme using the CIELAB system. The adjacent keratized gingiva region was divided into two equal zones (coronal and middle) as the apical region corresponded to non-keratinized mucosa. For each region, mean L\*, a\*, and b\* values were calculated.

    Through study completion, an average of 6 months

Secondary Outcomes (8)

  • Keratinized Gingiva Width

    Baseline

  • Periodontal pocket depth

    Baseline

  • Clinical attachment level

    Baseline

  • Measurement of gingival thickness

    Baseline

  • Influence of age on color values

    Through study completion, an average of 6 months

  • +3 more secondary outcomes

Study Arms (1)

Clinical Periodontal Measurements and Digital Imaging

For each tooth within the FGG treated sites, probing pocket depth (PD), clinical attachment level (CAL), and keratinized gingiva width (KGW) were recorded. The thickness of the FGG and adjacent keratinized gingiva (KG) was assessed using a transgingival method. Standardized intraoral photographs were obtained from the study population.

Eligibility Criteria

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

This retrospective cohort study included patients from the Department of Periodontology, Faculty of Dentistry, Bezmialem Vakıf University, who had undergone conventional free gingival graft (FGG) in the mandibular anterior region involving one or two teeth.

You may qualify if:

  • Postoperative period of at least 6 months after FGG
  • Age between 18 and 65 years
  • No known systemic diseases
  • No use of medications adversely affecting gingival health (e.g., calcium channel blockers, immunosuppressants, antiepileptics)
  • Full-mouth plaque index (PI)(1) and gingival index (GI)(2) \< 1
  • Probing pocket depth (PPD) ≤ 3 mm with no bleeding on probing (BOP)(3) in the mandibular anterior teeth
  • Absence of habitual mouth breathing

You may not qualify if:

  • Current smoking
  • Pregnancy or lactation
  • Previous endodontic or restorative treatment in the mandibular anterior teeth
  • Parafunctional habits (e.g., bruxism) or history of orthodontic treatment
  • Conditions impairing salivary flow (e.g., Sjögren's syndrome or similar disorders)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem Vakif University

Istanbul, Fatih, 34093, Turkey (Türkiye)

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2025

First Posted

September 30, 2025

Study Start

March 20, 2023

Primary Completion

August 5, 2023

Study Completion

April 20, 2025

Last Updated

September 30, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Data will be made available upon publication of the manuscript

Locations