NCT06502782

Brief Summary

Recent advances in digital technology have led to the emergence of precise methods for measuring gingival recession and tissue thickness. This study aimed to compare digital measurement methods and conventional periodontal probe measurements for the assessment of gingival recession influenced by the gingival phenotype. This study involved 128 gingival recession sites from 28 systemically healthy patients aged 18-45 years. The participants were categorized into two groups on the basis of gingival thickness. The plaque index, gingival index, probing depth, clinical attachment level, gingival recession depth, and gingival recession width, and keratinized gingival thickness and width were measured using a manual periodontal probe and an intraoral optical surface scanner. Statistical analysis was performed with nonparametric tests because the data were not normally distributed. P\<0.05 indicated statistical significanct.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
128

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2022

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

November 12, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 12, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 12, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 9, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 16, 2024

Completed
Last Updated

February 4, 2025

Status Verified

February 1, 2025

Enrollment Period

1 year

First QC Date

July 9, 2024

Last Update Submit

February 2, 2025

Conditions

Gingival Recession

Keywords

GingivaGingival recessionScreening

Outcome Measures

Primary Outcomes (4)

  • keratinized gingival thickness

    Keratinized gingival thickness refers to the vertical measurement of the gingival tissue that extends from the free gingival margin to the mucogingival junction, characterized by a keratinized epithelial layer which provides enhanced protection and stability to the underlying periodontal structures.

    Baseline

  • keratinized gingival width

    Keratinized gingival width refers to the horizontal dimension of the gingival tissue that is keratinized, measured from the free gingival margin to the mucogingival junction.

    Baseline

  • Gingival recession depth

    Gingival recession is the apical migration of the gingival margin away from the cemento-enamel junction (CEJ), resulting in the exposure of the root surface of a tooth.

    Baseline

  • Gingival recession width

    Gingival recession width refers to the horizontal measurement from the exposed cemento-enamel junction (CEJ) to the apical point of the gingival margin, indicating the extent of root surface exposure.

    Baseline

Secondary Outcomes (5)

  • Plaque index

    Baseline

  • Gingival index

    Baseline

  • Bleeding on probing

    Baseline

  • Periodontal pocket depth

    Baseline

  • Clinical attachment level

    Baseline

Study Arms (2)

Thin phenotype

A thickness of 1 mm or less is classified as thin gingival tissue.

Diagnostic Test: digital assesment

Thick phenotype

A thickness of more than 1 mm is classified as thick gingival tissue.

Diagnostic Test: digital assesment

Interventions

digital assesmentDIAGNOSTIC_TEST

Gingival recession sites were scanned with an intraoral optical surface scanner, and STL images were recorded. The images were imported into image analysis software. The depth, width and area of gingival recession were calculated using Autocat program.

Thick phenotypeThin phenotype

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

The study included 128 gingival recessions at 128 sites in 28 systemically healthy patients aged 18-45 years old. The patients were divided into two groups according to the thickness of the gingiva in the teeth with gingival recession.

You may not qualify if:

  • Patients with a history of radiotherapy,
  • Patients with chemotherapy,
  • Immunosuppressive use,
  • Tobacco use,
  • Smoking,
  • Patients with labially exposed teeth and teeth with prominent root protrusions,
  • Pregnancy and lactation,
  • Patients with uncontrolled diabetes,
  • Patients with postorthodontic extractions,
  • Patients with gingival recession, .Patients with gingival enlargement caused by piercing and nail-biting habits.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bolu Abant İzzet Baysal University

Bolu, Bolu, 14030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

July 9, 2024

First Posted

July 16, 2024

Study Start

November 12, 2022

Primary Completion

November 12, 2023

Study Completion

April 12, 2024

Last Updated

February 4, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)