A Comparison of the Outcomes of Two Existing Routine Clinical Therapies for Dental Prophylaxis

NCT03471325 | Completed

• 1 other identifier: 2016/00916
• Study Type: interventional
• Target: 89
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background: In most practices, conventional in-office prophylaxis starts immediately with scaling and polishing. Therefore, this project was designed to challenge tradition by comparing plaque removal efficacy of rubber cup and air polishing in two scenarios, one where plaque was disclosed prior to treatment and the other where plaque was not disclosed. Methods: In this randomized, single blind, split-mouth design clinical trial, healthy, non-smoking participants with poor oral hygiene were recruited. Quadrants in each participant were randomly assigned to 4 treatment groups, which were plaque disclosure with rubber cup polishing, no plaque disclosure with rubber cup polishing, plaque disclosure with air polishing, and no plaque disclosure with air polishing. Examiners were calibrated and masked to the treatment rendered in each quadrant. Post treatment satisfaction questionnaires for both participants and operators were completed. Plaque scores for each quadrant and treatment time were the recorded outcome measures.

Conditions

Gingivitis

Keywords

plaque removal

Outcome Measures

Primary Outcomes (1)

• post treatment plaque score

  plaque score based on Loe and Silness 1963. Minimum score is 0. Maximum score is 1. It is a categorical scale of 0 or 1 and is not a continuous scale. 0 is a good outcome and 1 is a poor outcome. Each side of the tooth will be recorded as either a 0 or a 1. It will be added up and averaged out by the number of tooth sides multiple by 100% to get a percentage total score. The higher the percentage, the worser the outcome.

  1 day

Secondary Outcomes (1)

• Treatment duration

  1 day

Study Arms (4)

Plaque Disclosed with Air Flow (PDAF)

EXPERIMENTAL

Plaque will be disclosed prior to polishing with the air flow system.

Procedure: Plaque disclosed with air flow

Plaque Disclosed with Rubber Cup (PD-RC)

EXPERIMENTAL

Plaque will be disclosed prior to polishing with the rubber cup and fine grit prophylaxis paste.

Procedure: Plaque disclosed with rubber cup

Non Plaque Disclosed Air Flow (NPD-AF)

EXPERIMENTAL

Air polishing system will be used to remove the plaque

Procedure: Non plaque disclosed air flow

Non Plaque Disclosed Rubber Cup (NPD-RC)

PLACEBO COMPARATOR

Rubber Cup polishing to remove plaque.

Procedure: Non plaque disclosed rubber cup

Interventions

Plaque disclosed with air flow PROCEDURE

air polishing with prior plaque disclosing

Also known as: EMS

Plaque Disclosed with Air Flow (PDAF)

Plaque disclosed with rubber cup PROCEDURE

rubber cup polishing with prior plaque disclosing

Also known as: Slow speed handpiece

Plaque Disclosed with Rubber Cup (PD-RC)

Non plaque disclosed air flow PROCEDURE

air polishing with no prior plaque disclosing

Also known as: EMS

Non Plaque Disclosed Air Flow (NPD-AF)

Non plaque disclosed rubber cup PROCEDURE

rubber cup polishing with no prior plaque disclosing

Also known as: Slow speed handpiece

Non Plaque Disclosed Rubber Cup (NPD-RC)

Eligibility Criteria

• Age: 21 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \) Age 21 to 35 years old
• \) Healthy
• \) Non-smoker
• \) With gingivitis and poor oral hygiene (plaque score of at least 50%)
• \) English literate

You may not qualify if:

• \) Smoker
• \) Pregnant or lactating females
• \) Unable to speak/read/write/communicate in English
• \) With dentures or bridges or braces

Sponsors & Collaborators

• National University Health System, Singapore: lead

MeSH Terms

Conditions

Gingivitis

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Jia Hui Fu

  National University Health System, Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The examiner, who chart the plaque score is blinded to the treatment assignment.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: In each subject, his/her right and left dentition will be randomized into Plaque Disclosed (PD) and Non Plaque Disclosed (NPD) groups. Subsequently, the upper and lower jaws will be randomized into Air Flow (AF) and Rubber Cup (RC).

Study Record Dates

• First Submitted: March 7, 2018
• First Posted: March 20, 2018
• Study Start: December 8, 2016
• Primary Completion: September 30, 2017
• Study Completion: December 14, 2017
• Last Updated: March 21, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share