DENTAL GUM TISSUE AGING

NCT06167798 | Completed

• 1 other identifier: 2012007
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is an epidemiological, cross-sectional two-visit study involving 100 Caucasian subjects representing 6 different age groups \[20 to 24 (20s), 30 to 34 (30s), 40 to 44 (40s), 50 to 54 (50s), 60 to 64 (60s), and 70 to 74 (70s)\]. Medically healthy subjects will receive a screening exam to determine their oral status. Subjects without periodontal disease will be enrolled in the study where two 2 mm gingival biopsy will be obtained using punch biopsy from the healthy attached gingiva around upper premolar teeth. Tissues will be processed and analyzed for histological and transcriptomics analyses targeting morphological changes and gene expression in gingival tissues with aging.

Conditions

Aging

Outcome Measures

Primary Outcomes (1)

• Association between age and gene expression

  Through the study completion, about 6 months

Interventions

biopsy OTHER

two 2 mm gingival biopsies were obtained.

Eligibility Criteria

• Age: 20 Years - 74 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Individuals between the ages of 20-74 with healthy oral tissues will be included.

You may qualify if:

• provide written informed consent to participate in the study.
• be at the ages specified within age groups.
• male or female of the Caucasian race
• agree not to participate in any other oral/dental product studies during the course of this study.
• agree to delay any elective dentistry (including dental prophylaxis) until the study has been completed.
• agree to return for all scheduled visits and follow study procedures.
• have at least 16 natural teeth (excluding wisdom teeth).
• be in good general health, as determined by the Investigator/designee based on a review of the health history/update for participation in the study.
• healthy gingival tissue suitable for biopsy in the maxillary premolar area (per examiner discretion).

You may not qualify if:

• use of antibiotics 3 months prior to the study
• smoking or smoking cessation \<1 year;
• any diseases or conditions to be expected to interfere with the examination or with the subject safely completing the study;
• history of drug use that is associated with gum overgrowth (i.e., dilantin, nifedipine, etc) or drugs that are known to inhibit salivary flow (i.e. antipsychotics etc.);
• chronic use of medication such as steroids, ibuprofen or acetylsalicylic acid (aspirin/ASA) more than 2-3 days/week), anti-coagulant medications, immunosuppressant medications or any other medications that in the opinion of the Investigator would interfere with the evaluation or confound interpretation of the study results. Use of low dose of ASA is permitted;
• previous gum surgery that might interfere with gum biopsy collection;
• presence or history of periodontal disease (at least 2 pockets 6mm);
• all teeth that are grossly carious, fully crowned, or extensively restored (per investigator discretion);
• any condition requiring the need for antibiotic pre-medication prior to dental procedures;
• current participation in any other oral/dental product studies;
• pregnancy or lactation;
• diabetes, autoimmune or infectious diseases, dry mouth, skin diseases;
• orthodontic appliances

Sponsors & Collaborators

• The Forsyth Institute: lead
• Procter and Gamble: collaborator

MeSH Terms

Interventions

Biopsy

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Design

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

Study Record Dates

• First Submitted: December 3, 2023
• First Posted: December 13, 2023
• Study Start: April 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: June 1, 2013
• Last Updated: December 13, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share