NCT05813444

Brief Summary

Several types of gingival phenotype can be diagnosed in the general population and their evaluation is an essential clinical criterion in periodontal practice, whether the periodontal therapies are preventive or curative, non-surgical or surgical. Moreover, several authors have shown that the gingival phenotype varies from one dental sector to another, hence the interest of a meticulous and targeted diagnostic approach in relation to the established therapeutic objectives. To date, the gingival phenotype has been not studied extensively in the mandibular incisal area. Therefore, it seems relevant to conduct an observational cross-sectional study on a cohort of patients in good general health and with a healthy and intact periodontium to assess the prevalence of the gingival phenotype in this area. The secondary objective is to highlight the associated intrinsic and extrinsic risk factors for thin gingival phenotype, to anticipate a risk of gingival recession and to propose an early personal therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 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

June 29, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 3, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 14, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 29, 2023

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

February 17, 2025

Status Verified

March 1, 2023

Enrollment Period

1.5 years

First QC Date

April 3, 2023

Last Update Submit

February 14, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Gingival phenotype prevalence

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

    18 months

Secondary Outcomes (1)

  • Associated risk factors for thin gingival phenotype

    18 months

Study Arms (1)

Main Cohort

Dental students on the university hospital of Nice

Eligibility Criteria

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

Dental student with healthy and intact periodontium

You may qualify if:

  • age (18 years old or older)
  • dental student on the university hospital of Nice
  • 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
  • presence of plaque
  • 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)

University Hospital of Nice

Nice, 06200, France

Location

Related Publications (1)

  • Dridi SM, Ameline C, Masucci C, Fontas E, Charavet C. Gingival phenotype prevalence of lower incisors and associated risk indicators in the French dental student population: a cross-sectional study. Clin Oral Investig. 2025 Feb 15;29(2):130. doi: 10.1007/s00784-025-06206-7.

MeSH Terms

Conditions

Gingival Diseases

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Design

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

Study Record Dates

First Submitted

April 3, 2023

First Posted

April 14, 2023

Study Start

June 29, 2022

Primary Completion

December 29, 2023

Study Completion

December 31, 2023

Last Updated

February 17, 2025

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations