NCT04326413

Brief Summary

Periodontal (gum) disease affecting more than 90% of the population globally. The soft and hard tissues that supporting the teeth are being affected. If untreated, the disease progresses from the mild and reversible form (i.e. gingivitis) that involves superficial gum only to the more severe and irreversible form (i.e. periodontitis) that involves loss of periodontal ligament and bone. Teeth will be lost eventually and significantly impairs the function and the oral health related quality of health. Moreover, periodontal disease has been strongly linked to the systemic diseases via centrally or local routes with significant health implications. Periodontal disease is initiated by bacteria (plaque) adhere on tooth surfaces and the body defense by eliciting inflammatory response. The disease and associated inflammation is site-specific and the affected gum is manifested with the cardinal signs of inflammation such as redness (color), swelling (increased volume), edema (loss of surface characteristics) and bleeds easily. Dentists are trained to identify the disease sites by visual (redness and swelling) and by mechanical probing (bleeding). Traditionally these give rises to clinical gum indices showing the degree of inflammation and are important to the clinical monitoring and management of gum diseases. The management of periodontal disease involves the removal of bacteria plaque by both dentists' tooth cleaning and maintained by patients' daily home-care. Home-care plaque removal has been shown by many studies to prevent and/or cease the development of periodontitis. However, most patients do not able to remove plaque effectively and it only takes few days for a health site to development inflammation. Professional monitoring and feedback are highly desirable but many patients only have monthly or even yearly appointment which is too late. Such "non-compliance" increase the treatment cost/time, patient discomfort and reduce treatment efficacy. Moreover, many patients do not receive regular dental checkup and they seek dentists when the gum problem becomes irreversible that complicated and expensive treatment such as tooth extraction and rehabilitation is required. This study consists of 1) collecting the standardized clinical photography with clinical gum indices/ marked by an experienced clinician, 2) import into computer for training, and 3) longitudinally monitoring and analyze of gum condition in a group of gingivitis patients receiving gum treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 30, 2020

Completed
2.8 years until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 24, 2025

Completed
Last Updated

March 28, 2025

Status Verified

March 1, 2025

Enrollment Period

2 years

First QC Date

March 25, 2020

Last Update Submit

March 24, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • Clinical gingival inflammation at 3 month

    Mean number/Percentage of sites with, as determined by the plaque index (Silness and Loe 1965 from 0 to 3) by observation of patient's mouth

    3-month

  • Photographic gingival inflammation at 3 month

    Mean number/Percentage of sites with, as determined by the plaque index (Silness and Loe 1965 from 0 to 3) by observation of patient's standardized photo

    3-month

  • Photographic gingival inflammation at baseline

    Mean number/Percentage of sites with, as determined by the plaque index (Silness and Loe 1965 from 0 to 3) by observation of patient's standardized photo

    baseline

  • Clinical gingival inflammation at baseline

    Mean number/Percentage of sites with, as determined by the plaque index (Silness and Loe 1965 from 0 to 3) by observation of patient's mouth

    baseline

Secondary Outcomes (1)

  • Patient reported outcome on the use of smartphone selfie

    3-month

Interventions

Monitor the changes of gum condition

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Healthy dentate patients with gingivitis only and have 24 or more teeth

You may qualify if:

  • Adult subjects attending PPDH and are able to give informed consent
  • Subjects who diagnosed to have gingivitis only and have 24 or more teeth
  • Subjects who are otherwise medically health
  • Subjects who are able to attend multiple dental visits

You may not qualify if:

  • Subjects who are in acute dental infection or in pain
  • Subjects who have oral mucosal diseases that preclude retraction of soft tissues for photos
  • Subjects who are in fixed appliance for orthodontic treatment
  • Subjects who are pregnancy, or medically unfit for periodontal charting or requires antibiotic coverage (e.g. risk of infective endocarditis)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince Philip Dental Hospital

Sai Ying Pun, Hong Kong

Location

MeSH Terms

Conditions

Gingivitis

Condition Hierarchy (Ancestors)

InfectionsGingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

March 25, 2020

First Posted

March 30, 2020

Study Start

January 1, 2023

Primary Completion

December 31, 2024

Study Completion

March 24, 2025

Last Updated

March 28, 2025

Record last verified: 2025-03

Locations