DenturePhase 4NCT03522272
Effectiveness of an Ultrasonic Denture Hygiene Intervention Program Among Community-dwelling Elders
A Phase 4 study testing Ultrasonic cleaning and Conventional denture hygiene in people with Denture and Removable Partial Denture, run by The University of Hong Kong.
Trial summary
Objectives: The objective of this study was to assess prospectively the effectiveness of ultrasonic denture hygiene interventions in improving denture cleanliness among community-dwelling elders. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Denture, Removable Partial Denture, Denture Cleansers
- What is being tested?
- Ultrasonic cleaning and Conventional denture hygiene
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- 20 Jun 2016to 20 Jun 2017
- Phase
- Phase 4
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- previously provided with cobalt chromium metal framework removable partial dentures (RPDs) within the past five years at Prince Philip Dental Hospital
Who cannot join
- -
About this study
Objectives: The objective of this study was to assess prospectively the effectiveness of ultrasonic denture hygiene interventions in improving denture cleanliness among community-dwelling elders. Methods: A randomized clinical trial was conducted among community-dwelling elders, in which a total of 66 subjects who received upper metal framework removable partial dentures in the past five years were recruited randomly from a computerized database. They were randomly allocated into three denture hygiene intervention groups: group 1 (mechanical cleaning with a toothbrush and ultrasonic cleaning with cetylpyridinium chloride mouthrinse), group 2 (mechanical cleaning with a toothbrush and ultrasonic cleaning with distilled water) and control (mechanical cleaning with a toothbrush only). Denture cleanliness was assessed at baseline and one month review using: i) Denture Cleanliness Index (DCI) scores; ii) plaque coverage percentage; and (iii) microbiological tests. Results: There were significantly greater reductions in mean DCI scores and mean percentage of plaque coverage area in group 1 and group 2 compared to the control group for both CoCr and acrylic fitting surfaces (p<0.001). Group 1 had significant reductions in the viable counts of bacteria (CoCr and acrylic) and yeast (CoCr only) (p<0.05), while only significant reductions in bacterial viable counts (CoCr and acrylic) (p<0.05) were documented in Group 2. No significant differences were detected between groups 1 and 2 with regards to all clinical and microbiological outcomes. When comparing these parameters for CoCr and acrylic surfaces, no significant differences were observed following the intervention period. Conclusions: The ultrasonic cleaner was significantly more effective than the control in the reduction of biofilm coverage on metal framework removable partial dentures during the one month intervention period. The adjunctive use of cetylpyridinium chloride with ultrasonic cleaning did not yield improved outcomes compared to water.
- Being tested
- Ultrasonic cleaning, Conventional denture hygiene
- Keywords
- denture, removable partial denture, denture cleansers, ultrasonics, cetylpyridinium chloride, Staphylococcus aureus, Gram negative bacilli, Candida, yeast
- Medical subject headings
- Staphylococcal Infections, Torulopsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonic cleaningDevice
Ultrasonic cleaning (frequency 42kHz) (for 7 minutes 30 seconds) with cetylpyridinium chloride
Ultrasonic cleaningDevice
Ultrasonic cleaning (frequency 42kHz) (for 7 minutes 30 seconds) with water
Conventional denture hygieneOther
Mechanical cleaning of denture with a soft toothbrush and liquid detergent
| Study group | Role | What they receive |
|---|---|---|
| Ultrasonic cleaning with cetylpyridinium chloride | Experimental | Mechanical cleaning of the RPD with a soft toothbrush and liquid detergent, and ultrasonic cleaning (frequency 42kHz) (for 7 minutes 30 seconds) of the denture with 0.07% cetylpyridinium chloride mouthrinse Receives: Device: Ultrasonic cleaning |
| Ultrasonic cleaning with water | Active comparator | Mechanical cleaning of the RPD with a soft toothbrush and liquid detergent, and ultrasonic cleaning (frequency 42kHz) (for 7 minutes 30 seconds) of the denture with distilled water Receives: Device: Ultrasonic cleaning |
| Conventional denture hygiene | Active comparator | Mechanical cleaning of the RPD with a soft toothbrush and liquid detergent (Control group) Receives: Other: Conventional denture hygiene |
What is being measured
The primary outcome is the main question the study is designed to answer.
Denture hygiene (visual assessment)
Denture Cleanliness Index (visual assessment)
Measured: one month
Secondary outcomes (4)
Denture hygiene (planimetric assessment)
Quantitative analysis of denture cleanliness was determined by obtaining photographic images and planimetric assessment
Measured: one month
Gram negative bacilli
Viable counts of aerobic and facultatively anaerobic bacteria
Measured: one month
Yeasts
Viable counts of yeasts
Measured: one month
Staphylococcus aureus
Viable counts of Staphylococcus aureus
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2018
- Study start20 Jun 2016
- Primary completion20 Jun 2017
- Study completion20 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DentureStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Otto Lok-Tao Lam, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03522272
- Sponsor's protocol ID
- UW16-266
- Status last verified
- Apr 2018
- First submitted
- 30 Apr 2018
- Last updated
- 11 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Ultrasonic Denture Hygiene Intervention Program Among Community-dwelling Elders
- ClinicalTrials.gov ID
- NCT03522272
- Acronym / sponsor ID
- UW16-266
- Keywords
- denture, removable partial denture, denture cleansers, ultrasonics, cetylpyridinium chloride, Staphylococcus aureus, Gram negative bacilli, Candida
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 20 Jun 2016 (actual)
- Primary completion
- 20 Jun 2017 (actual)
- Study completion
- 20 Jun 2017 (actual)
- First posted
- 11 May 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.
Objectives: The objective of this study was to assess prospectively the effectiveness of ultrasonic denture hygiene interventions in improving denture cleanliness among community-dwelling elders. Methods: A randomized clinical trial was conducted among community-dwelling elders, in which a total of 66 subjects who received upper metal framework removable partial dentures in the past five years were recruited randomly from a computerized database. They were randomly allocated into three denture hygiene intervention groups: group 1 (mechanical cleaning with a toothbrush and ultrasonic cleaning with cetylpyridinium chloride mouthrinse), group 2 (mechanical cleaning with a toothbrush and ultrasonic cleaning with distilled water) and control (mechanical cleaning with a toothbrush only). Denture cleanliness was assessed at baseline and one month review using: i) Denture Cleanliness Index (DCI) scores; ii) plaque coverage percentage; and (iii) microbiological tests. Results: There were significantly greater reductions in mean DCI scores and mean percentage of plaque coverage area in group 1 and group 2 compared to the control group for both CoCr and acrylic fitting surfaces (p<0.001). Group 1 had significant reductions in the viable counts of bacteria (CoCr and acrylic) and yeast (CoCr only) (p<0.05), while only significant reductions in bacterial viable counts (CoCr and acrylic) (p<0.05) were documented in Group 2. No significant differences were detected between groups 1 and 2 with regards to all clinical and microbiological outcomes. When comparing these parameters for CoCr and acrylic surfaces, no significant differences were observed following the intervention period. Conclusions: The ultrasonic cleaner was significantly more effective than the control in the reduction of biofilm coverage on metal framework removable partial dentures during the one month intervention period. The adjunctive use of cetylpyridinium chloride with ultrasonic cleaning did not yield improved outcomes compared to water.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ultrasonic cleaning with cetylpyridinium chloride | Experimental | Device: Ultrasonic cleaningMechanical cleaning of the RPD with a soft toothbrush and liquid detergent, and ultrasonic cleaning (frequency 42kHz) (for 7 minutes 30 seconds) of the denture with 0.07% cetylpyridinium chloride mouthrinse |
| Ultrasonic cleaning with water | Active comparator | Device: Ultrasonic cleaningMechanical cleaning of the RPD with a soft toothbrush and liquid detergent, and ultrasonic cleaning (frequency 42kHz) (for 7 minutes 30 seconds) of the denture with distilled water |
| Conventional denture hygiene | Active comparator | Other: Conventional denture hygieneMechanical cleaning of the RPD with a soft toothbrush and liquid detergent (Control group) |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- previously provided with cobalt chromium metal framework removable partial dentures (RPDs) within the past five years at Prince Philip Dental Hospital
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Ultrasonic cleaningUltrasonic cleaning (frequency 42kHz) (for 7 minutes 30 seconds) with cetylpyridinium chloride | Device | Ultrasonic cleaning with cetylpyridinium chloride |
| Ultrasonic cleaningUltrasonic cleaning (frequency 42kHz) (for 7 minutes 30 seconds) with water | Device | Ultrasonic cleaning with water |
| Conventional denture hygieneMechanical cleaning of denture with a soft toothbrush and liquid detergent | Other | Conventional denture hygiene |
Primary outcome
Denture hygiene (visual assessment)
Time frame: one month
Denture Cleanliness Index (visual assessment)
4 secondary outcomes
Denture hygiene (planimetric assessment)
Time frame: one month
Gram negative bacilli
Time frame: one month
Yeasts
Time frame: one month
Staphylococcus aureus
Time frame: one month
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 11 May 2018.
Related trials for Denture
Active, not recruiting
Clinical Evaluation of a New Printable Denture Base Material
Edentulous Mouth
Recruiting
Comparison of Conventional and Face Scan in Recording the Vertical Dimension of Completely Edentulous Patients
Edentulous Complete Denture Wearers
Not yet recruitingObservational study
Digital and Conventional Clasp-retained Partial Dentures (DIGICLASP)
Partial Edentulism
Active, not recruiting
Single-implant Versus Two-implant Mandibular Overdentures
Edentulism
Not yet recruiting
Comparison Between Neutral Zone and Admixed Impression Techniques for Atrophic Mandibular Ridges
Atrophic Mandibular Ridge in Edentulous Patients
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ultrasonic cleaning and Conventional denture hygiene in people with Denture and Removable Partial Denture, run by The University of Hong Kong.
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 1 inclusion and 1 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 11 May 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Denture hygiene (visual assessment) (time frame: one month). 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 11 May 2018.