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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05813444
Other study ID # 23Odonto02
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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