GingivitisNCT03471325
A Comparison of the Outcomes of Two Existing Routine Clinical Therapies for Dental Prophylaxis
A study testing Plaque disclosed with air flow, Plaque disclosed with rubber cup and Non plaque disclosed air flow in people with Gingivitis, run by National University Health System, Singapore.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingivitis
- What is being tested?
- Plaque disclosed with air flow, Plaque disclosed with rubber cup and Non plaque disclosed air flow
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 89 participants
- Where
- No sites listed yet
- Study dates
- 8 Dec 2016to 14 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 1) Smoker
- 2) Pregnant or lactating females
- 3) Unable to speak/read/write/communicate in English
- 4) With dentures or bridges or braces
About this study
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.
Read the 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
- Being tested
- Plaque disclosed with air flow, Plaque disclosed with rubber cup, Non plaque disclosed air flow, Non plaque disclosed rubber cup
- Keywords
- plaque removal
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plaque disclosed with air flowProcedure or surgery
Also called EMS
air polishing with prior plaque disclosing
Plaque disclosed with rubber cupProcedure or surgery
Also called Slow speed handpiece
rubber cup polishing with prior plaque disclosing
Non plaque disclosed air flowProcedure or surgery
Also called EMS
air polishing with no prior plaque disclosing
Non plaque disclosed rubber cupProcedure or surgery
Also called Slow speed handpiece
rubber cup polishing with no prior plaque disclosing
| Study group | Role | What they receive |
|---|---|---|
| Plaque Disclosed with Air Flow (PDAF) | Experimental | Plaque will be disclosed prior to polishing with the air flow system. Receives: 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. Receives: Procedure: Plaque disclosed with rubber cup |
| Non Plaque Disclosed Air Flow (NPD-AF) | Experimental | Air polishing system will be used to remove the plaque Receives: Procedure: Non plaque disclosed air flow |
| Non Plaque Disclosed Rubber Cup (NPD-RC) | Placebo comparator | Rubber Cup polishing to remove plaque. Receives: Procedure: Non plaque disclosed rubber cup |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Secondary outcomes (1)
Treatment duration
Time taken to complete the polishing by the air flow system or rubber cup polishing
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2018
- Study start8 Dec 2016
- Primary completion30 Sep 2017
- Study completion14 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GingivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University Health System, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jia Hui Fu, National University Health System, Singapore
- Investigators
- Jia Hui Fu, Principal investigator, National University Health System, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03471325
- Sponsor's protocol ID
- 2016/00916
- Other IDs
- 2016
- Status last verified
- Mar 2018
- First submitted
- 7 Mar 2018
- Last updated
- 21 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Outcomes of Two Existing Routine Clinical Therapies for Dental Prophylaxis
- ClinicalTrials.gov ID
- NCT03471325
- Acronym / sponsor ID
- 2016/00916
- Conditions
- Gingivitis
- Keywords
- plaque removal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- National University Health System, SingaporeUniversity, hospital or other
- Study start
- 8 Dec 2016 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 14 Dec 2017 (actual)
- First posted
- 20 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- 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).
| Arm | Type | Receives |
|---|---|---|
| Plaque Disclosed with Air Flow (PDAF) | Experimental | Procedure: Plaque disclosed with air flowPlaque will be disclosed prior to polishing with the air flow system. |
| Plaque Disclosed with Rubber Cup (PD-RC) | Experimental | Procedure: Plaque disclosed with rubber cupPlaque will be disclosed prior to polishing with the rubber cup and fine grit prophylaxis paste. |
| Non Plaque Disclosed Air Flow (NPD-AF) | Experimental | Procedure: Non plaque disclosed air flowAir polishing system will be used to remove the plaque |
| Non Plaque Disclosed Rubber Cup (NPD-RC) | Placebo comparator | Procedure: Non plaque disclosed rubber cupRubber Cup polishing to remove plaque. |
Who may qualify
- Ages
- 21 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 1) Smoker
- 2) Pregnant or lactating females
- 3) Unable to speak/read/write/communicate in English
- 4) With dentures or bridges or braces
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plaque disclosed with air flowAlso: EMSair polishing with prior plaque disclosing | Procedure or surgery | Plaque Disclosed with Air Flow (PDAF) |
| Plaque disclosed with rubber cupAlso: Slow speed handpiecerubber cup polishing with prior plaque disclosing | Procedure or surgery | Plaque Disclosed with Rubber Cup (PD-RC) |
| Non plaque disclosed air flowAlso: EMSair polishing with no prior plaque disclosing | Procedure or surgery | Non Plaque Disclosed Air Flow (NPD-AF) |
| Non plaque disclosed rubber cupAlso: Slow speed handpiecerubber cup polishing with no prior plaque disclosing | Procedure or surgery | Non Plaque Disclosed Rubber Cup (NPD-RC) |
Primary outcome
post treatment plaque score
Time frame: 1 day
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 secondary outcome
Treatment duration
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jia Hui Fu principal investigator
National University Health System, Singapore
Questions about this trial
What is this clinical trial studying?
A study testing Plaque disclosed with air flow, Plaque disclosed with rubber cup and Non plaque disclosed air flow in people with Gingivitis, run by National University Health System, Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post treatment plaque score (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2018.