Gingival Phenotype Prevalence of Lower Incisors and Associated Risk Factors : a Cross-sectional Study

Sponsor

Centre Hospitalier Universitaire de Nice (Other)

Overall Status

Recruiting

CT.gov ID

NCT05813444

Collaborator

(none)

120

Enrollment

Location

Anticipated Duration (Months)

6.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gingival Diseases

Study Design

Study Type:

Observational

Anticipated Enrollment :

120 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

Gingival Phenotype Prevalence of Lower Incisors and Associated Risk Factors in French Dental Students Population : a Cross-sectional Study

Actual Study Start Date :

Jun 29, 2022

Anticipated Primary Completion Date :

Dec 29, 2023

Anticipated Study Completion Date :

Dec 29, 2023

Arms and Interventions

Arm	Intervention/Treatment
Main Cohort Dental students on the university hospital of Nice

Outcome Measures

Primary Outcome Measures

Gingival phenotype prevalence [18 months]
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.

Secondary Outcome Measures

Associated risk factors for thin gingival phenotype [18 months]
Age, gender, smoking habit, orthodontic background, oral hygiene habit, oral ventilation, dysfunction, facial typology, chin shape, visibility of vascularisation and root convexity through the gum, gingival recession (Cairo), frenal insertion and skin type.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital of Nice	Nice		France	06200

Sponsors and Collaborators

Centre Hospitalier Universitaire de Nice

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire de Nice

ClinicalTrials.gov Identifier:

NCT05813444

Other Study ID Numbers:

23Odonto02

First Posted:

Apr 14, 2023

Last Update Posted:

Apr 18, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Gingival Diseases

Study Results

No Results Posted as of Apr 18, 2023