AgingNCT06167798
AGING EFFECTS ON DENTAL GUM TISSUE
An observational study of Aging, run by The Forsyth Institute.
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. Read more about this study
- Who is it for?
- Ages 20 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- biopsy
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Apr 2012to Jun 2013
- 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 20 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals between the ages of 20-74 with healthy oral tissues will be included.
Who may be able to join
- 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.
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- 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).
Who cannot join
- 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;
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- 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
About this study
Official title: EFFECT OF AGING ON THE GENE EXPRESSION AND HISTOMORPHOLOGY OF DENTAL GUM TISSUE
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.
Read the 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 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.
- Conditions
- Aging
- Being tested
- biopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biopsyOther
Two 2-mm gingival biopsies will be obtained.
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between age and gene expression
Gene expression in gingival tissues will be studied with regard to age of the study participants
Measured: Through the study completion, about 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2023
- Study startApr 2012
- Primary completionJan 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Forsyth Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Procter and Gamble
- Responsible party
- Sponsor
- Investigators
- Hatice Hasturk, DDS., Ph.D., Principal investigator, Forsyth Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06167798
- Sponsor's protocol ID
- 2012007
- Status last verified
- Sep 2026
- First submitted
- 3 Dec 2023
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECT OF AGING ON THE GENE EXPRESSION AND HISTOMORPHOLOGY OF DENTAL GUM TISSUE
- ClinicalTrials.gov ID
- NCT06167798
- Acronym / sponsor ID
- 2012007
- Conditions
- Aging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- The Forsyth InstituteUniversity, hospital or other
- Collaborators
- Procter and Gamble
- Study start
- Apr 2012 (actual)
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 13 Dec 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.
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.
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 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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals between the ages of 20-74 with healthy oral tissues will be included.
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| biopsyTwo 2-mm gingival biopsies will be obtained. | Other | – |
Primary outcome
Association between age and gene expression
Time frame: Through the study completion, about 6 months
Gene expression in gingival tissues will be studied with regard to age of the study participants
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 10 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Hatice Hasturk, DDS., Ph.D. principal investigator
Forsyth Institute
Questions about this trial
What is this clinical trial studying?
An observational study of Aging, run by The Forsyth Institute.
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 9 inclusion and 13 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 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Association between age and gene expression (time frame: Through the study completion, about 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Sep 2026.