A Comparison of the Outcomes of Two Existing Routine Clinical Therapies for Dental Prophylaxis
Primary Purpose
Gingivitis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Plaque disclosed with air flow
Plaque disclosed with rubber cup
Non plaque disclosed air flow
Non plaque disclosed rubber cup
Sponsored by
About this trial
This is an interventional treatment trial for Gingivitis focused on measuring plaque removal
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
Plaque Disclosed with Air Flow (PDAF)
Plaque Disclosed with Rubber Cup (PD-RC)
Non Plaque Disclosed Air Flow (NPD-AF)
Non Plaque Disclosed Rubber Cup (NPD-RC)
Arm Description
Plaque will be disclosed prior to polishing with the air flow system.
Plaque will be disclosed prior to polishing with the rubber cup and fine grit prophylaxis paste.
Air polishing system will be used to remove the plaque
Rubber Cup polishing to remove plaque.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Treatment duration
Time taken to complete the polishing by the air flow system or rubber cup polishing
Full Information
NCT ID
NCT03471325
First Posted
March 7, 2018
Last Updated
March 20, 2018
Sponsor
National University Health System, Singapore
1. Study Identification
Unique Protocol Identification Number
NCT03471325
Brief Title
A Comparison of the Outcomes of Two Existing Routine Clinical Therapies for Dental Prophylaxis
Official Title
A Comparison of the Outcomes of Two Existing Routine Clinical Therapies for Dental Prophylaxis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
December 8, 2016 (Actual)
Primary Completion Date
September 30, 2017 (Actual)
Study Completion Date
December 14, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National University Health System, Singapore
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingivitis
Keywords
plaque removal
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
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).
Masking
ParticipantOutcomes Assessor
Masking Description
The examiner, who chart the plaque score is blinded to the treatment assignment.
Allocation
Randomized
Enrollment
89 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Plaque Disclosed with Air Flow (PDAF)
Arm Type
Experimental
Arm Description
Plaque will be disclosed prior to polishing with the air flow system.
Arm Title
Plaque Disclosed with Rubber Cup (PD-RC)
Arm Type
Experimental
Arm Description
Plaque will be disclosed prior to polishing with the rubber cup and fine grit prophylaxis paste.
Arm Title
Non Plaque Disclosed Air Flow (NPD-AF)
Arm Type
Experimental
Arm Description
Air polishing system will be used to remove the plaque
Arm Title
Non Plaque Disclosed Rubber Cup (NPD-RC)
Arm Type
Placebo Comparator
Arm Description
Rubber Cup polishing to remove plaque.
Intervention Type
Procedure
Intervention Name(s)
Plaque disclosed with air flow
Other Intervention Name(s)
EMS
Intervention Description
air polishing with prior plaque disclosing
Intervention Type
Procedure
Intervention Name(s)
Plaque disclosed with rubber cup
Other Intervention Name(s)
Slow speed handpiece
Intervention Description
rubber cup polishing with prior plaque disclosing
Intervention Type
Procedure
Intervention Name(s)
Non plaque disclosed air flow
Other Intervention Name(s)
EMS
Intervention Description
air polishing with no prior plaque disclosing
Intervention Type
Procedure
Intervention Name(s)
Non plaque disclosed rubber cup
Other Intervention Name(s)
Slow speed handpiece
Intervention Description
rubber cup polishing with no prior plaque disclosing
Primary Outcome Measure Information:
Title
post treatment plaque score
Description
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.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Treatment duration
Description
Time taken to complete the polishing by the air flow system or rubber cup polishing
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jia Hui Fu
Organizational Affiliation
National University Health System, Singapore
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Comparison of the Outcomes of Two Existing Routine Clinical Therapies for Dental Prophylaxis
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