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Clinical Trial 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.


Clinical Trial 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 64 (60s), and 70 to 74 (70s)]. From each group, eighteen subjects (9 females and 9 males) will be recruited (except for the 60's and 70's groups where 14 subjects/group - 7 females and 7 males, will be recruited). At the screening visit, subjects will receive an oral soft tissue (OST) exam followed by a full periodontal exam including probing pocket depth (PPD), the difference between gingival margin and cementoenamel junction, clinical attachment level (CAL), and bleeding on probing (BOP). Subjects who meet all inclusion/exclusion criteria will receive a professional dental exam to assess the clinical status of their mouth; additionally, they will have an image of the anterior teeth taken and will fill out a questionnaire on their oral hygiene habits. At the second study visit, a 3 ml saliva sample will be collected for a saliva flow rate assessment and biomarkers analysis. Subgingival plaque samples will be taken with paper points from the tooth adjacent to the selected biopsy area, i.e. the upper second premolar. Additionally, blood (10 ml) samples for biomarker analysis and two- 2 mm-punch gingival biopsies for gene expression and histomorphology evaluations will be taken from each subject. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06167798
Study type Observational
Source The Forsyth Institute
Contact
Status Completed
Phase
Start date April 2012
Completion date June 2013

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