Gingival DiseasesNCT05813444
Gingival Phenotype Prevalence of Lower Incisors and Associated Risk Factors : a Cross-sectional Study
An observational study of Gingival Diseases, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gingival Diseases
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 29 Jun 2022to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Dental student with healthy and intact periodontium
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gingival Phenotype Prevalence of Lower Incisors and Associated Risk Factors in French Dental Students Population : a Cross-sectional Study
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.
- Conditions
- Gingival Diseases
- Medical subject headings
- Gingival Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Main Cohort | Dental students on the university hospital of Nice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 months
Secondary outcomes (1)
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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2023
- Study start29 Jun 2022
- Primary completion29 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gingival DiseasesStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05813444
- Sponsor's protocol ID
- 23Odonto02
- Status last verified
- Mar 2023
- First submitted
- 3 Apr 2023
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39953292
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gingival Phenotype Prevalence of Lower Incisors and Associated Risk Factors in French Dental Students Population : a Cross-sectional Study
- ClinicalTrials.gov ID
- NCT05813444
- Acronym / sponsor ID
- 23Odonto02
- Conditions
- Gingival Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 29 Jun 2022 (actual)
- Primary completion
- 29 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 14 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Main Cohort | – | –Dental students on the university hospital of Nice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Dental student with healthy and intact periodontium
Key inclusion criteria (6 listed)
- age (18 years old or older)
- dental student on the university hospital of Nice
- social security affiliate
- systemically healthy
- healthy and intact periodontium
Key exclusion criteria (8 listed)
- pregnancy
- under any regular medical treatment
- active periodontal disease
- presence of plaque
- enduring orthodontic treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Gingival phenotype prevalence
Time frame: 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.
1 secondary outcome
Associated risk factors for thin gingival phenotype
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
- Derived from this study: PubMed 39953292Dridi 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.
- Individual participant dataSharing planned: No
Related trials for Gingival Diseases
Not yet recruitingPhase 1/2
Acute Nicotine Gum and Auditory Brain Responses in Adults With Chronic Tinnitus
Tinnitus, Chronic Subjective Tinnitus
Not yet recruiting
Free Soft Tissue Grafts (FSTG) Using Autograft Palatal Donor Tissue vs. Xenograft Collagen Matrix (Zderm™)
Gingival Recession Localized Moderate, Dental Implant
Enrolling by invitation
Comparison of the Effects of Oral Hygiene Regimens on Clinical, Immunomodulatory, and Microbial Outcomes and Oral Tolerance in People With Gingivitis
Microbiome, Cytokines
Recruiting
i-PRF-Based Bioactive Matrix vs. Connective Tissue Graft in the Treatment of Gingival Recessions
Gingival Graft, Recession, Gingival
Active, not recruitingPhase 3
A Study to Assess the Efficacy of Two Brushing Regimens in the Reduction of Established Dental Plaque and Gingivitis
Plaque, Gingivitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gingival Diseases, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gingival phenotype prevalence (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05813444, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2025.