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

NCT ID: NCT03471325

Last Updated: 2018-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 89 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-08
• Study Completion Date: 2017-12-14

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.

Detailed Description

According to the literature search, there was no preceding study, which compared the efficacy of conventional routine of rubber cup or air powder polishing with or without prior plaque disclosure. Therefore, this study was designed to test the hypotheses that (1) disclosing plaque prior to dental polishing was more effective than dental polishing alone, (2) air polishing was more efficient than rubber cup polishing, and (3) operators and patients prefer air polishing to rubber cup polishing.

In order to evaluate the hypotheses raised, a single blind, randomised controlled clinical trial with a split mouth design was conducted. The control groups had conventional dental prophylaxis regime of mechanical plaque removal with either fine air powder polishing or rubber cup polishing using fine grit prophylaxis paste. The test groups had plaque disclosure prior to mechanical plaque removal as described for the control groups. In total, there were 4 study groups: (1) rubber cup polishing without prior plaque disclosure (RC-NPD) (negative control), (2) rubber cup polishing with prior plaque disclosure (RC-PD) (positive control), (3) air polishing without prior plaque disclosure (AF-NPD) (negative test), and (4) air polishing with prior plaque disclosure (AF-PD) (positive test).

The quadrant that was assigned to receive RC-NPD was treated first followed by the quadrant assigned to receive AF-NPD. Plaque was disclosed in all 4 quadrants and the assigned calibrated examiner proceeded to chart the FMPS. Next, the quadrant assigned to receive RC-PD was treated, followed by the quadrant assigned to receive AF-PD; subsequently FMPS was charted. Any aberrant findings in occlusion, tooth alignment, extra/missing teeth were also noted. A digital stopwatch was used to time the treatment duration for each quadrant. Both participant and clinician completed a post prophylaxis satisfaction questionnaire. The treatment workflow used in this study was illustrated in figure 1. The primary outcome measure was the post treatment FMPS and the secondary outcomes measures were the treatment duration.

Descriptive statistics (mean and standard deviations) was used to summarize the plaque score and treatment duration for each study group. Two-way repeated measure ANOVA test was employed to examine the study hypotheses that air polishing was more effective in removing plaque compared to rubber cup polishing and disclosing plaque prior to prophylaxis increased the thoroughness of the prophylaxis. Two-way repeated measure ANOVA test was also performed to study the treatment duration between the 2 polishing methods and treatment regimens of with or without plaque disclosure prior to prophylaxis. In a secondary analysis, interactions were tested to study if there were differences among the 4 operators. Paired T-test and Pearson's Chi-Square tests were used to study the participant's and operator's preference for each treatment modality based on various yardsticks and overall, respectively. The level of significance was set at p-value<0.05. All statistical analyses were carried out using a statistical package.

Conditions

Gingivitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Plaque Disclosed with Air Flow (PDAF)

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

Group Type: EXPERIMENTAL

Plaque disclosed with air flow

Intervention Type: PROCEDURE

air polishing with prior plaque disclosing

Plaque Disclosed with Rubber Cup (PD-RC)

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

Group Type: EXPERIMENTAL

Plaque disclosed with rubber cup

Intervention Type: PROCEDURE

rubber cup polishing with prior plaque disclosing

Non Plaque Disclosed Air Flow (NPD-AF)

Air polishing system will be used to remove the plaque

Group Type: EXPERIMENTAL

Non plaque disclosed air flow

Intervention Type: PROCEDURE

air polishing with no prior plaque disclosing

Non Plaque Disclosed Rubber Cup (NPD-RC)

Rubber Cup polishing to remove plaque.

Group Type: PLACEBO_COMPARATOR

Non plaque disclosed rubber cup

Intervention Type: PROCEDURE

rubber cup polishing with no prior plaque disclosing

Interventions

Plaque disclosed with air flow

air polishing with prior plaque disclosing

Intervention Type: PROCEDURE

Plaque disclosed with rubber cup

rubber cup polishing with prior plaque disclosing

Intervention Type: PROCEDURE

Non plaque disclosed air flow

air polishing with no prior plaque disclosing

Intervention Type: PROCEDURE

Non plaque disclosed rubber cup

rubber cup polishing with no prior plaque disclosing

Intervention Type: PROCEDURE

Other Intervention Names

EMS; Slow speed handpiece; EMS; Slow speed handpiece

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National University Health System, Singapore

OTHER

Sponsor Role: lead

Responsible Party

Jia Hui Fu

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jia Hui Fu

Role: PRINCIPAL_INVESTIGATOR

National University Health System, Singapore

Other Identifiers

2016/00916

Identifier Type: -

Identifier Source: org_study_id