Assessment of Different Imaging Systems for Dental Plaque Scoring

NCT05612009 | Completed DMC FDA Device

• 1 other identifier: S1s7s9s3
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to analyze the correlation between the dental plaque indices measured different imaging systems and conventional clinical indices that assess dental plaque. From among the patients who visited Marmara University, Faculty of Dentistry 30 adults between the age of 18-30, who had under 3 DMFT scores, were selected for full-mouth imaging. Digital dental photography, digital scanning system and fluorecam methods were used for taking intraoral images. The Turesky Modified Quigley Hein Plaque Index (TMQHPI) was scored both by the clinical examination method and on the images taken. The correlations between the clinical examinaton, digital photography, digital scanning system and fluorecam scores were analyzed. Maxillary and mandibulary anterior teeth's buccal surfaces were scored to TMQHPI after using disclosing agent.

Conditions

Dental Plaque Imaging Methods

Keywords

dental plaque; dental photography; digital scanning system; fluorecam; Turesky Modified Quigley Hein Plaque Index

Outcome Measures

Primary Outcomes (5)

• 1. Dental plaque scoring clinically before staining agent

  Dental plaque of the volunteer's anterior teeth were scored to Turesky Modified Quigley Hein Plaque Index

  15 minutes

• 2. Dental plaque scoring clinically after applying staining agent

  Dental plaque of the volunteer's anterior teeth were scored to Turesky Modified Quigley Hein Plaque Index

  15 minutes

• 3.Dental plaque scoring after applying staining agent on the taken images with FluoreCam

  Dental plaque of the volunteer's anterior teeth were scored on the images taken with FluoreCam to Turesky Modified Quigley Hein Plaque Index

  45 minutes

• 4. Dental plaque scoring after applying staining agent on the taken images with Digital Camera

  Dental plaque of the volunteer's anterior teeth were scored on the images taken with FluoreCam to Turesky Modified Quigley Hein Plaque Index

  45 minutes

• 5. Dental plaque scoring after applying staining agent on the taken images with Intraoral Scanner

  Dental plaque of the volunteer's anterior teeth were scored on the images taken with Intraoral Scanner to Turesky Modified Quigley Hein Plaque Index

  1 hour

Study Arms (3)

1. Signal Expert Protection

After scoring clinically and with dental plaque imaging methods, Signal Expert Protection toothpaste was given to 10 volunteers.

Combination Product: Toothpastes

2. Colgate Hemp Seed Oil

After scoring clinically and with dental plaque imaging methods, Colgate Hemp Seed Oil toothpaste was given to 10 volunteers.

Combination Product: Toothpastes

3. Gumgumix

After scoring clinically and with dental plaque imaging methods, Gumgumix toothpaste was given to 10 volunteers.

Combination Product: Toothpastes

Interventions

Toothpastes COMBINATION_PRODUCT

Signal Expert Protection: Conventional toothpaste including Sodium Lauryl Sulphate and fluoride. Colgate Hemp Seed Oil: Herbal toothpaste including hemp seed oil and also fluoride. Gumgumix: Herbal toothpaste including ginger extract (no fluoride).

Also known as: Signal Expert Protection, Colgate Hemp Seed Oil, Gumgumix

1. Signal Expert Protection; 2. Colgate Hemp Seed Oil; 3. Gumgumix

Eligibility Criteria

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

Study Population

The study was performed with 30 adult male and female patients aged between 18-35, recruited from among the outpatients who visited the Marmara University, Faculty of Dentistry, Restorative Dentistry Department, agreed to the terms of the experiment, had a DMFT score 3 or lower, and had relatively even teeth arrangement. Among patients, those with orthodontic bracket placed, severe crowding of teeth not visually verified in the photograph, fixed or implant restoration installed, more than 3 DMFT score, and serious systemic diseases were excluded from the study.

You may qualify if:

• The volunteers between the ages of 18-35, No systemic disease, Teeth that do not contain hereditary, morphological, drug-induced structural changes, Not using orthodontic wires and appliances, Having a DMFT score of 3 and less than 3, Have not received antibiotic treatment in the last 6 weeks, Not using mouthwash in the last 6 weeks, Without dental calculus, Oral hygiene habits are similar to each other, University student or graduate, Thirty volunteers who were conscious of being able to understand and apply the guidelines set forth in the study were included.

You may not qualify if:

• Among volunteers, those with orthodontic bracket placed, severe crowding of teeth not visually verified in the photograph, fixed or implant restoration installed, more than 3 DMFT score, and serious systemic diseases were excluded from the study.

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University Department of Restorative Dentistry

Istanbul, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

dental plaque samples of volunteers

MeSH Terms

Conditions

Dental Plaque

Interventions

Toothpastes

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dentifrices; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

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

Study Record Dates

• First Submitted: November 3, 2022
• First Posted: November 10, 2022
• Study Start: May 17, 2021
• Primary Completion: July 2, 2021
• Study Completion: August 27, 2021
• Last Updated: November 10, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: data will be available in 2 years.
• Access Criteria: all researchers may access the data of this study

Locations

TU (1)