Status:
COMPLETED
DENTAL GUM TISSUE AGING
Lead Sponsor:
The Forsyth Institute
Collaborating Sponsors:
Procter and Gamble
Conditions:
Aging
Eligibility:
All Genders
20-74 years
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...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06167798
Start Date
April 1 2012
End Date
June 1 2013
Last Update
December 13 2023
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