Dental Implants, Single-ToothNCT03575858
The Effect of Different Shapes of Interdental Brushes in the Management of Peri-implant Mucositis and Gingivitis
A study testing Barrel shaped interdental brush and Tapered interdental brush in people with Dental Implants, Single-Tooth, run by National University Health System, Singapore.
Trial summary
Rehabilitation of edentulous spaces with dental implants has become a routine treatment option as implants enjoy high survival rates over time. Accompanying this increase in implant use, epidemiological studies have also reported escalating incidences of peri-implant diseases. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Dental Implants, Single-Tooth
- What is being tested?
- Barrel shaped interdental brush and Tapered interdental brush
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2018to 31 Dec 2020
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 21-80 years old
- Medically healthy (ASA I or II)
- Baseline plaque score of at least 75%
- Probing depths of 4mm or less
- Presence of interdental spaces that will allow an interdental brush (Size SS 0.8mm for barrel-shaped interdental brush and 0.6mm tapered interdental brush) to pass through without soft tissue trauma
- Single moderately rough tissue level or bone level dental implants, which were restored with a single cement or screw-retained crown and in function for the past 2-5 years
- Implants should have peri-implant mucositis defined as bleeding on probing without peri-implant bone loss after physiological remodelling (Rosen, et al. 2013)
- Implants with at least 1mm of keratinized peri-implant mucosa
Who cannot join
- Embrasure space between the implant and adjacent tooth or between teeth is non-existent or too small to permit the use of an interdental brush
- Self-declared pregnancy
- Heavy smokers (1 pack a day)
- Uncontrolled or poorly controlled medical conditions e.g. diabetes (HBA1c 8.5% and above)
- Untreated oral conditions e.g. active periodontitis
- On medications that will cause gingival enlargement
Show all 9Show fewer
- Any hyperplastic interdental papilla that will hinder interdental cleaning
- Antibiotics intake within the past 3 months
- Parkinson's disease and other debilitating diseases
About this study
Official title: Comparison of Barrel Shaped and Tapered Interdental Brushes in the Management of Peri-implant Mucositis and Gingivitis in Healthy Individuals: A Randomized Controlled Single Blinded Clinical Trial
Rehabilitation of edentulous spaces with dental implants has become a routine treatment option as implants enjoy high survival rates over time. Accompanying this increase in implant use, epidemiological studies have also reported escalating incidences of peri-implant diseases. A recent meta-analysis reported that peri-implant mucositis and peri-implantitis had high estimated weighted mean prevalences of 43% and 22% respectively. It is common knowledge that gingivitis is the precursor of periodontitis. Similarly, peri-implant mucositis too precedes peri-implantitis, which is a very challenging condition to treat. Therefore, it is strongly recommended that peri-implant mucositis is managed effectively and in a timely manner.
In order to reduce the inflammatory burden within the periodontium, mechanical plaque removal is of utmost importance. Mechanical debridement alone, without any adjunctive aids e.g. chlorhexidine, was found to be effective in preventing per-implant mucositis in short-term clinical trials but did not always result in complete resolution of inflammation (Heitz-Mayfield, et al. 2011, Schwarz, et al. 2015). Therefore, it can be speculated that patient administered home care may play a role in eliminating soft tissue inflammation over time.
Read more
The study aims to investigate and compare the efficacy of the barrel shaped and tapered interdental brushes in reduction of soft tissue inflammation through removal of interproximal plaque at both tooth and implant sites in patients with moderately rough surface tissue level or bone level dental implants, which were restored with single screw or cement retained crowns and in function for the past 2- 5 years.
The hypothesis of the study is that The barrel shaped interdental brush can remove more supra- and sub-gingival plaque and thus have more reduction in soft tissue inflammation, compared to the tapered interdental brush.
Read the detailed description
There are two study phases during the whole course of the study.
- Examiner Calibration: 15 volunteers will be recruited for examiner calibration before the study period. The intra-examiner reliability will be assessed using intraclass correlation coefficient. The following clinical parameters will be collected at day 0 and day 7.
Clinical Parameters:
- Probing pocket depths (PPD) (6 points per tooth) ii. Full mouth bleeding score (FMBS) iii. Plaque at 8 sites (mesiobuccal, mesial, mesiolingual, lingual, distolingual, distal, distobuccal, and buccal) per implant
- Study phase: Stratified randomized single-blinded clinical controlled trial with 2 parallel arms is designed to achieve the aims of this research project. Study participants who are visiting University Dental Cluster or any other dental clinics or hospitals will be referred for this study. They will be enrolled at NUH University Dental Cluster if they fulfill the study inclusion and exclusion criteria. They will be randomly assigned into the barrel shaped (test) and tapered (control) interdental brushes groups and reviewed at 2 weeks (± 3 days) and 4 weeks (± 3 days).
Randomization:
Study subjects will be randomly assigned to either test or control group based on a computer generated randomization code after the screening of inclusion and exclusion criteria and signing of the informed consent form.
Blinding and Allocation Concealment:
The study examiner who will be doing the clinical examination and collecting the study data will be blinded to the group allocation; however, it is not possible to blind the study subjects to the group allocation. The clinician, who will be performing the treatment and providing oral hygiene instructions, will be given a sequentially numbered envelope containing the subject's group allocation after non-surgical periodontal therapy has been performed and before giving the oral hygiene instructions.
- Probing pocket depths (PPD) (6 points per tooth) ii. Full mouth bleeding score (FMBS) iii. Full mouth plaque score (FMPS) iv. Plaque at 8 sites (mesiobuccal, mesial, mesiolingual, lingual, distolingual, distal, distobuccal, and buccal) per implant v. Characteristics of the implant and implant crown: tissue level or bone level, supra- or submucosal margin, degree of overcontour as seen on periapical radiograph vi. Peri-apical radiograph of implant taken with parallel technique
Clinical parameters (i) to (iv) will be performed at baseline, 2-weeks and 4-weeks post instrumentation.
Clinical parameter (v) and (vi) will be performed at baseline.
Radiographic Analysis:
Peri-apical radiographs will be only taken with paralleling technique to determine that there is no peri-implant bone loss at baseline.
The sample size is calculated based on changes in mean bleeding on probing (BOP) (primary outcome measure) between baseline and at 2 weeks post instrumentation review. Based on a previous study (Larsen, et al. 2017), investigators calculated that 88 subjects (44 per group) would be needed with 5% significance level and 80% statistical power. If investigators expect an attrition rate of 20%, a total of 110 subjects (55 per group) will be needed.
Statistical Analysis:
Intention-to-treat analysis on the primary outcome variable (BOP) will be performed. Last-observation-carried-forward method will be used in the event of subjects lost to follow-up to the end of the study.
Descriptive statistics (mean and standard deviation for continuous variable; frequency and percentage for categorical variable) will be reported to summarize the baseline characteristics of study participants. Primary analysis will be patient-level analysis and secondary analysis will be implant-level analysis. One implant, will be randomly selected by computer generated random number, from each recruited subjects for patient-level analysis. All implants from the recruited subjects will be included in the implant-level analysis.
At patient-level analysis, to examine the effect of shape of interdental brush, difference-in-difference technique will be used for study the changes of outcomes (e.g. BOP, PPD, FMBS and FMPS) from baseline at 2-weeks. Two-way ANOVA test with adjusting for implant types will also be performed to study the effect of interdental brush shape in the form of changes in BOP, PPD, FMBS and FMPS, at 2-week. Similar analysis will be replicated for secondary study endpoint at 4-week. Generalized estimating equation (GEE) will be applied to incorporate repeated measures data collected at 2- and 4-weeks. Baseline data and types of implants will be adjusted in the model.
At implant-level analysis, to adjust for within-patient dependency, multilevel mixed effects model will be built to assess the effect of interdental brush shape on the study outcome variables (e.g. BOP, PPD, FMBS and FMPS) over time. A multilevel hierarchical three-level structure was chosen with three levels of analysis being: timing of follow-up measurements (level 1), implant (level 2), and patient (level 3). Baseline values of study outcome variables and types of implants will be adjusted in the model.
Significance level for all analysis is set at p-value <0.05. All statistical analysis will be carried out using STATA SE Version 15.0 (StataCorp. 2017. Stata Statistical Software: Release 15. College Station, TX: StataCorp LLC).
- Conditions
- Dental Implants, Single-Tooth
- Being tested
- Barrel shaped interdental brush, Tapered interdental brush
- Keywords
- Single dental implants, Barrel Shaped Interdental toothbrush, Tapered Interdental toothbrush, peri-implant mucositis and gingivitis
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Barrel shaped interdental brushDevice
Barrel shaped interdental brush Size SS 0.8mm
Tapered interdental brushDevice
Tapered interdental brush Size SS 0.6mm
| Study group | Role | What they receive |
|---|---|---|
| Barrel shaped interdental brushes | Experimental | test group Receives: Device: Barrel shaped interdental brush |
| Tapered interdental brushes | Active comparator | control group Receives: Device: Tapered interdental brush |
What is being measured
The primary outcome is the main question the study is designed to answer.
The changes in peri-implant tissue health as assessed by bleeding on probing (BOP).
The changes in BOP at 6 sites per implant at 3 time points - from baseline to 2-weeks and to 4-weeks.
Measured: Baseline, 2-week and 4-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2018
- Study start15 Dec 2018 (estimated)
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2020 (estimated)
Why it stopped: Barrel shaped interdental brush went out of production
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Implants, Single-ToothStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned into the barrel shaped (test) and tapered (control) interdental brushes groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 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, Master, Principal investigator, National University Health System, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03575858
- Sponsor's protocol ID
- 2017/01230
- Other IDs
- 2017
- Status last verified
- Mar 2019
- First submitted
- 6 Jun 2018
- Last updated
- 13 Mar 2019
- 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 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Barrel Shaped and Tapered Interdental Brushes in the Management of Peri-implant Mucositis and Gingivitis in Healthy Individuals: A Randomized Controlled Single Blinded Clinical Trial
- ClinicalTrials.gov ID
- NCT03575858
- Acronym / sponsor ID
- 2017/01230
- Conditions
- Dental Implants, Single-Tooth
- Keywords
- Single dental implants, Barrel Shaped Interdental toothbrush, Tapered Interdental toothbrush, peri-implant mucositis and gingivitis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Barrel shaped interdental brush went out of production
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National University Health System, SingaporeUniversity, hospital or other
- Study start
- 15 Dec 2018 (estimated)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 3 Jul 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.
Rehabilitation of edentulous spaces with dental implants has become a routine treatment option as implants enjoy high survival rates over time. Accompanying this increase in implant use, epidemiological studies have also reported escalating incidences of peri-implant diseases. A recent meta-analysis reported that peri-implant mucositis and peri-implantitis had high estimated weighted mean prevalences of 43% and 22% respectively. It is common knowledge that gingivitis is the precursor of periodontitis. Similarly, peri-implant mucositis too precedes peri-implantitis, which is a very challenging condition to treat. Therefore, it is strongly recommended that peri-implant mucositis is managed effectively and in a timely manner.
In order to reduce the inflammatory burden within the periodontium, mechanical plaque removal is of utmost importance. Mechanical debridement alone, without any adjunctive aids e.g. chlorhexidine, was found to be effective in preventing per-implant mucositis in short-term clinical trials but did not always result in complete resolution of inflammation (Heitz-Mayfield, et al. 2011, Schwarz, et al. 2015). Therefore, it can be speculated that patient administered home care may play a role in eliminating soft tissue inflammation over time.
The study aims to investigate and compare the efficacy of the barrel shaped and tapered interdental brushes in reduction of soft tissue inflammation through removal of interproximal plaque at both tooth and implant sites in patients with moderately rough surface tissue level or bone level dental implants, which were restored with single screw or cement retained crowns and in function for the past 2- 5 years.
The hypothesis of the study is that The barrel shaped interdental brush can remove more supra- and sub-gingival plaque and thus have more reduction in soft tissue inflammation, compared to the tapered interdental brush.
Detailed description
There are two study phases during the whole course of the study.
- Examiner Calibration: 15 volunteers will be recruited for examiner calibration before the study period. The intra-examiner reliability will be assessed using intraclass correlation coefficient. The following clinical parameters will be collected at day 0 and day 7.
Clinical Parameters:
- Probing pocket depths (PPD) (6 points per tooth) ii. Full mouth bleeding score (FMBS) iii. Plaque at 8 sites (mesiobuccal, mesial, mesiolingual, lingual, distolingual, distal, distobuccal, and buccal) per implant
- Study phase: Stratified randomized single-blinded clinical controlled trial with 2 parallel arms is designed to achieve the aims of this research project. Study participants who are visiting University Dental Cluster or any other dental clinics or hospitals will be referred for this study. They will be enrolled at NUH University Dental Cluster if they fulfill the study inclusion and exclusion criteria. They will be randomly assigned into the barrel shaped (test) and tapered (control) interdental brushes groups and reviewed at 2 weeks (± 3 days) and 4 weeks (± 3 days).
Randomization:
Study subjects will be randomly assigned to either test or control group based on a computer generated randomization code after the screening of inclusion and exclusion criteria and signing of the informed consent form.
Blinding and Allocation Concealment:
The study examiner who will be doing the clinical examination and collecting the study data will be blinded to the group allocation; however, it is not possible to blind the study subjects to the group allocation. The clinician, who will be performing the treatment and providing oral hygiene instructions, will be given a sequentially numbered envelope containing the subject's group allocation after non-surgical periodontal therapy has been performed and before giving the oral hygiene instructions.
- Probing pocket depths (PPD) (6 points per tooth) ii. Full mouth bleeding score (FMBS) iii. Full mouth plaque score (FMPS) iv. Plaque at 8 sites (mesiobuccal, mesial, mesiolingual, lingual, distolingual, distal, distobuccal, and buccal) per implant v. Characteristics of the implant and implant crown: tissue level or bone level, supra- or submucosal margin, degree of overcontour as seen on periapical radiograph vi. Peri-apical radiograph of implant taken with parallel technique
Clinical parameters (i) to (iv) will be performed at baseline, 2-weeks and 4-weeks post instrumentation.
Clinical parameter (v) and (vi) will be performed at baseline.
Radiographic Analysis:
Peri-apical radiographs will be only taken with paralleling technique to determine that there is no peri-implant bone loss at baseline.
The sample size is calculated based on changes in mean bleeding on probing (BOP) (primary outcome measure) between baseline and at 2 weeks post instrumentation review. Based on a previous study (Larsen, et al. 2017), investigators calculated that 88 subjects (44 per group) would be needed with 5% significance level and 80% statistical power. If investigators expect an attrition rate of 20%, a total of 110 subjects (55 per group) will be needed.
Statistical Analysis:
Intention-to-treat analysis on the primary outcome variable (BOP) will be performed. Last-observation-carried-forward method will be used in the event of subjects lost to follow-up to the end of the study.
Descriptive statistics (mean and standard deviation for continuous variable; frequency and percentage for categorical variable) will be reported to summarize the baseline characteristics of study participants. Primary analysis will be patient-level analysis and secondary analysis will be implant-level analysis. One implant, will be randomly selected by computer generated random number, from each recruited subjects for patient-level analysis. All implants from the recruited subjects will be included in the implant-level analysis.
At patient-level analysis, to examine the effect of shape of interdental brush, difference-in-difference technique will be used for study the changes of outcomes (e.g. BOP, PPD, FMBS and FMPS) from baseline at 2-weeks. Two-way ANOVA test with adjusting for implant types will also be performed to study the effect of interdental brush shape in the form of changes in BOP, PPD, FMBS and FMPS, at 2-week. Similar analysis will be replicated for secondary study endpoint at 4-week. Generalized estimating equation (GEE) will be applied to incorporate repeated measures data collected at 2- and 4-weeks. Baseline data and types of implants will be adjusted in the model.
At implant-level analysis, to adjust for within-patient dependency, multilevel mixed effects model will be built to assess the effect of interdental brush shape on the study outcome variables (e.g. BOP, PPD, FMBS and FMPS) over time. A multilevel hierarchical three-level structure was chosen with three levels of analysis being: timing of follow-up measurements (level 1), implant (level 2), and patient (level 3). Baseline values of study outcome variables and types of implants will be adjusted in the model.
Significance level for all analysis is set at p-value <0.05. All statistical analysis will be carried out using STATA SE Version 15.0 (StataCorp. 2017. Stata Statistical Software: Release 15. College Station, TX: StataCorp LLC).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned into the barrel shaped (test) and tapered (control) interdental brushes groups
| Arm | Type | Receives |
|---|---|---|
| Barrel shaped interdental brushes | Experimental | Device: Barrel shaped interdental brushtest group |
| Tapered interdental brushes | Active comparator | Device: Tapered interdental brushcontrol group |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 21-80 years old
- Medically healthy (ASA I or II)
- Baseline plaque score of at least 75%
- Probing depths of 4mm or less
- Presence of interdental spaces that will allow an interdental brush (Size SS 0.8mm for barrel-shaped interdental brush and 0.6mm tapered interdental brush) to pass through without soft tissue trauma
Key exclusion criteria (9 listed)
- Embrasure space between the implant and adjacent tooth or between teeth is non-existent or too small to permit the use of an interdental brush
- Self-declared pregnancy
- Heavy smokers (1 pack a day)
- Uncontrolled or poorly controlled medical conditions e.g. diabetes (HBA1c 8.5% and above)
- Untreated oral conditions e.g. active periodontitis
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 |
|---|---|---|
| Barrel shaped interdental brushBarrel shaped interdental brush Size SS 0.8mm | Device | Barrel shaped interdental brushes |
| Tapered interdental brushTapered interdental brush Size SS 0.6mm | Device | Tapered interdental brushes |
Primary outcome
The changes in peri-implant tissue health as assessed by bleeding on probing (BOP).
Time frame: Baseline, 2-week and 4-week
The changes in BOP at 6 sites per implant at 3 time points - from baseline to 2-weeks and to 4-weeks.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2019.
- Individual participant dataSharing planned: No
Related trials for Dental Implants, Single-Tooth
Not yet recruiting
Safety Assessment of Placing a Single Dental Implant Without Antibiotic Prophylaxis in Simple Cases: A Pilot Study
Tooth Loss and Rehabillitation, Dental Implant Failure
Active, not recruiting
L-PRF Block vs Composite Graft for Horizontal Ridge Augmentation
Alveolar Ridge Resorption After Extraction, Alveolar Bone Loss
Not yet recruiting
Immediate vs Conventional Loading With Different Crown Materials on Immediately Placed Single Implants
Partial Edentulism, Dental Implant
Not yet recruiting
Do Immediate Digital Workflows Increase Patient Value?
Dental Implant, Implant Therapy
Active, not recruiting
Enhancing Soft Tissues Around Inserted Implants by Two Different Methods
Missing Teeth
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, Master principal investigator
National University Health System, Singapore
Questions about this trial
What is this clinical trial studying?
A study testing Barrel shaped interdental brush and Tapered interdental brush in people with Dental Implants, Single-Tooth, 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 8 inclusion and 9 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: withdrawn, as of the sponsor's last update on 13 Mar 2019. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
The changes in peri-implant tissue health as assessed by bleeding on probing (BOP). (time frame: Baseline, 2-week and 4-week). 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 13 Mar 2019.