Individual Variability of Experimental Gingivitis Response

NCT05656417 | Unknown

• 1 other identifier: 316902
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gingivitis; Oral Disease

Keywords

Experimental gingivitis; Periodontal disease; Gingival disease; Infectogenomics; Oral health; Dental plaque

Outcome Measures

Primary Outcomes (1)

• Löe-Silness Gingival Index: Min 0 - Max 3; Higher score indicates more gingival inflammation and a worse outcome.

  Change from baseline.

  Intervals over 6 weeks.

Secondary Outcomes (4)

• Silness-Löe Plaque Index: Min 0 - Max 3; Higher score indicates more plaque accumulation and a worse outcome.

  Intervals over 6 weeks.

• Bleeding on Probing: Min 0 - Max 1; Higher score indicates bleeding at the gingival site and a worse outcome.

  Intervals over 6 weeks.

• Microbial dysbiosis (detection and counts of subgingival microbes).

  Intervals over 6 weeks.

• Inflammatory markers (e.g. matrix metalloproteinase-8 and IL-1β) in blood, gingival crevicular fluid and saliva samples: Higher levels indicate a greater degree of gingival inflammation.

  Intervals over 6 weeks.

Study Arms (2)

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.

Behavioral: Temporary cessation of all oral hygiene

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.

Behavioral: Temporary cessation of all oral hygiene

Interventions

Temporary cessation of all oral hygiene BEHAVIORAL

Participants will refrain from all oral hygiene for 3 weeks.

Also known as: Experimental gingivitis

Haplotype 1; Haplotype 2

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Gingivally healthy young adults

You may qualify if:

• 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:
• 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.
• bleeding on probing (BOP) \< 30% at the Screening visit and BOP \<10% at Day -7.

You may not qualify if:

• 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)

Sponsors & Collaborators

• King's College London: lead
• Unilever R&D: collaborator
• Guy's and St Thomas' NHS Foundation Trust: collaborator
• Biotechnology and Biological Sciences Research Council: collaborator

Study Sites (1)

Centre for Host-Microbiome Interactions, Guy's Hospital

London, SE1 9RT, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Samples will include saliva, whole blood, serum, sub- and supra- gingival plaque, gingival crevicular fluid.

MeSH Terms

Conditions

Gingivitis; Mouth Diseases; Periodontal Diseases; Gingival Diseases; Dental Plaque

Condition Hierarchy (Ancestors)

Infections; Stomatognathic Diseases; Dental Deposits; Tooth Diseases

Study Officials

• Luigi Nibali, PhD

  King's College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luigi Nibali, PhD

CONTACT

02071888801; luigi.nibali@kcl.ac.uk

Dewi R Owen, BSc

CONTACT

020 7188 8094; dewi.owen@kcl.ac.uk

Study Design

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

Study Record Dates

• First Submitted: November 25, 2022
• First Posted: December 19, 2022
• Study Start: January 19, 2023
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: October 16, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)