Individual Variability of Experimental Gingivitis Response

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

56 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-19

Study Completion Date

2025-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The study aims to investigate the genetic cause of the variability between individuals seen in the development of the gum disease, gingivitis. This will be carried out through a 3 week programme where all oral hygiene is ceased, allowing 'experimental gingivitis' to develop, followed by a period of recovery when tooth cleaning is restored. Clinical assessments and biological samples will be taken during the course of the study for further analysis.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Clinical Investigation to Assess the Efficacy of Manual Toothbrushes in the Reduction of Plaque and Gingivitis.

NCT06565897

Plaque, Dental Gingivitis

ACTIVE_NOT_RECRUITING PHASE2

Variation in Gingival Inflammatory Responses

NCT05968742

Gingivitis

RECRUITING NA

A Study to Measure the Effect of a Toothpaste Containing Proteins and Enzymes and a Fluoride Toothpaste on Gingival Health

NCT06932211

Gingival Inflammation Dental Plaque

COMPLETED NA

A Study to Measure the Effect of Two Fluoride Toothpastes on Gingival Health Over a Six Month Period

NCT03027908

Gingival Diseases

COMPLETED NA

Effect of a Toothpaste and Serum Compared to Standard Fluoride Toothpaste on Gingival Health Over a Six Month Period.

NCT02676440

Healthy

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The purpose of the project is to investigate the factors which influence the oral disease, gingivitis. Gingivitis is the inflammation (swelling, redness, pain) of the gums, caused by the build-up of bacteria in the mouth. Research shows that the severity, extent and rate of development of gingivitis varies considerably between individuals. The aim of this project therefore is to investigate if an individual's DNA contributes to this range in outcomes and what impact it has on the human and bacterial cells in the mouth. This will be investigated through a period where all tooth brushing and oral hygiene will cease, and the changes in the mouth measured as the temporary 'experimental gingivitis' develops. Clinical measurements will include plaque build-up, levels of inflammation and bleeding scores, while samples of blood, saliva and plaque will be used to quantify changes in inflammatory markers and bacterial community composition.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gingivitis Oral Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Haplotype 1

Participants will attend a screening visit where they will provide a saliva sample for DNA sequencing. Participants will then be separated into two groups based on their gene profile. Participants in Group 1 will have a specific haplotype of the gene of interest. The groups will undergo a 2-week period of thorough oral hygiene and prophylactic treatment to achieve excellent gingival health. Participants in both groups will then cease all oral hygiene for a period of 3 weeks, where a state of gingivitis will develop. At the end of the 3 weeks, normal oral hygiene will be reinstated and prophylactic treatment offered as required for a further 2 weeks.

Temporary cessation of all oral hygiene

Intervention Type BEHAVIORAL

Participants will refrain from all oral hygiene for 3 weeks.

Haplotype 2

Participants will attend a screening visit where they will provide a saliva sample for DNA sequencing. Participants will then be separated into two groups based on their gene profile. Group 2 will comprise of participants who possess a second distinct haplotype in the same gene of interest as Group 1. This group will undergo the same study procedures as Haplotype Group 1.

Temporary cessation of all oral hygiene

Intervention Type BEHAVIORAL

Participants will refrain from all oral hygiene for 3 weeks.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Temporary cessation of all oral hygiene

Participants will refrain from all oral hygiene for 3 weeks.

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Experimental gingivitis

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age 18 to 35
* Caucasian
* No history of periodontitis/periodontal treatment (based on self-reported history)
* Medical history clear of cardiovascular disease, diabetes, cerebrovascular disease, kidney or liver disease, cancer, HIV, Tuberculosis and Hepatitis C (self-reported)
* Never smoker, e-cigarettes or nicotine gum use (self-reported). Individuals who rarely socially smoked more than 5 years ago would be permitted to participate.
* Minimum of 24 teeth present
* Be willing and competent (verbally and cognitively) to give written informed consent and complete a medical history form
* Be willing and physically able to carry out all study procedures
* Not have had a scale and prophylaxis in the previous month or have one scheduled prior to the end of the study
* Participant in good periodontal health, based on:

1. absence of interproximal probing pocket depths (PPD) and clinical attachment level (CAL) \> 3mm (with the exception of distal surfaces of third molars in the presence of impacted third molars) at the screening visit.
2. bleeding on probing (BOP) \< 30% at the Screening visit and BOP \<10% at Day -7.

Exclusion Criteria

* Currently taking part in other clinical trials
* Pregnant or breastfeeding women
* Taking medications including systemic anti-inflammatory medication within 3 months of the study (NSAIDs, no more than once per week and not in the week before sample collection, is permitted)
* Systemic antibiotic intake within 6 months
* Psychiatric conditions affecting participation in the study
* The participant is also a member of staff who is part of the study team
* Current orthodontic treatment
* Regular consumption of alcohol exceeding the government recommended levels
* Denture wearer/presence of dental implants/bridges
* Have oral piercings
* Obvious signs of untreated caries
* Taking dietary supplements (e.g. multivitamins; antioxidants; fish oils)

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes