NCT06981871

Brief Summary

The determination of the periodontal phenotype is an essential part of the periodontal diagnostic process, which must guide not only treatment but also prognosis (Kim et al. 2020). This determination is based on the clinical assessment of 3 individual variables: gingival height/thickness and alveolar bone cortical thickness. Although these anatomical characteristics are genetically determined, they are also influenced by numerous acquired, endogenous or exogenous factors that can act at a general and/or local level. The periodontal phenotype is therefore specific to an individual and its 3 components vary over time according to the dental sectors and sites of each individual. For example, the morphology of this phenotype varies according to whether the gingiva is thick or thin, high or reduced, and the bone cortex is thick or thin, with all possible combinations. Clinicians need to know the distribution of these different types of phenotypes, particularly in the aesthetic areas they are concerned with, in order to better identify the most fragile ones in the face of the multiple daily stresses to which the periodontium may be subjected: muscular force, dental plaque, oral hygiene manoeuvres, parafunctionality, dental procedures.... However, studies on the prevalence of the periodontal phenotype are limited and mainly concern Asian, Indian and American populations, with very few studies on European populations. Main objective: To assess the prevalence of periodontal phenotypes in the upper and lower incisors of French subjects, according to tooth type and at the individual level. Secondary objective: Identification of potential risk indicators in relation to the type of periodontal phenotype."

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
245

participants targeted

Target at P75+ for all trials

Timeline
2mo left

Started Jul 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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 Progress85%
Jul 2025Jul 2026

First Submitted

Initial submission to the registry

May 13, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 21, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

May 21, 2025

Status Verified

May 1, 2025

Enrollment Period

1 year

First QC Date

May 13, 2025

Last Update Submit

May 19, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Prevalence of gingival phenotypes (gingival thickness )

    Assessment of gingival thickness

    At the inclusion

  • Prevalence of gingival phenotypes (keratinised tissue height)

    Evaluation of keratinised tissue height of the lower and upper incisors with UNC-15 peridontal probe (mm) and clinical photography.

    At the inclusion

  • Prevalence of gingival phenotypes (Photography)

    Description of the gingiva

    At the inclusion

Secondary Outcomes (2)

  • Associated risk indicators for thin gingival phenotype ( Clinical description)

    At the inclusion

  • Associated risk indicators for thin gingival phenotype ( orthodontic and facial characteristics )

    At the inclusion

Interventions

Assessment of gingival thickness (Kan et al 2015) and keratinised tissue height of the incisors with UNC-15 peridontal probe (Hu-Freidy, USA) and clinical photography.

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Dental students at the university hospitals of Nice and Nancy (France)

You may qualify if:

  • Age (18 years old or older),
  • Dental student on the university hospitals of Nice and Nancy.
  • Social security affiliate.
  • Systemically healthy.
  • Healthy and intact periodontium.
  • Informed consent.

You may not qualify if:

  • Pregnancy.
  • Under any regular medical treatment.
  • Active periodontal disease.
  • Enduring orthodontic treatment.
  • Periodontal surgery in the mandibulary anterior region.
  • Non consent patient.
  • Patient under judgment trials.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU NICE

Nice, Alpes Maritimes, 06000, France

Location

Central Study Contacts

:Sophie-Myriam D Dridi

CONTACT

Study Design

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

Study Record Dates

First Submitted

May 13, 2025

First Posted

May 21, 2025

Study Start

July 1, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

May 21, 2025

Record last verified: 2025-05

Locations