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

Gingival Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05813444
• Other study ID #: 23Odonto02
• Status: Recruiting
• Start date: June 29, 2022
• Est. completion date: December 29, 2023

Study information

• Verified date: March 2023
• Source: Centre Hospitalier Universitaire de Nice
• Contact: Sophie-Myriam DRIDI
• Phone: +33619299208
• Email: dr.sm.dridi[@]free.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 29, 2023
• Est. primary completion date: December 29, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gingival Diseases

Locations

Country	Name	City	State
France	University Hospital of Nice	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Associated risk factors for thin gingival phenotype	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.	18 months