search
Back to results

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
National University Health System, Singapore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingivitis focused on measuring plaque removal

Eligibility Criteria

21 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    March 7, 2018
    Last Updated
    March 20, 2018
    Sponsor
    National University Health System, Singapore
    search

    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

    We'll reach out to this number within 24 hrs