Dental ImplantNCT03872687
The Effectiveness of Single Tufted Brush in the Management of Peri-implant Mucositis
A study testing single tufted brush with IDB and interdental brushes in people with Dental Implant, run by National University Health System, Singapore.
Trial summary
The study aims to investigate and compare the reduction in (1) soft tissue inflammation and (2) amount of plaque accumulation at implant sites with (test) or without (control) patient administered use of single tufted brush. Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Implant
- What is being tested?
- single tufted brush with IDB and interdental brushes
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- 7 Jun 2019to 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 21-70 years old ii. Medically healthy (ASA I or II) iii. Presence of interdental spaces that will allow an interdental brush to pass through without soft tissue trauma iv. Single moderately rough 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 v. Implants should have peri-implant mucositis that is defined as (Renvert, et al., 2018)
- Presence of clinical signs of inflammation, which are redness, shininess of the soft tissue surface, local swelling, with or without increase in probing depth
- Bleeding on probing
- No progressive peri-implant bone loss beyond 2mm from implant platform (Rosen, et al., 2013) vi. Implants with at least 1mm of keratinized peri-implant mucosa
Who cannot join
- Embrasure space between the implant and adjacent tooth is non-existent or too small to permit the use of an interdental brush ii. Self declared pregnancy iii. Heavy smokers (1 pack a day) iv. Uncontrolled or poorly controlled medical conditions e.g. diabetes (HBA1c 8.5% and above) v. Untreated oral conditions e.g. active periodontitis vi. On medications that will cause gingival enlargement vii. Any hyperplastic interdental papilla that will hinder interdental cleaning viii. Antibiotics intake within the past 3 months ix. Parkinson's disease and other debilitating diseases x. Subjects who are unable to give consent e.g. mentally challenged
Trial locations and contacts
No sites are listed yet.
About this study
Official title: An Evaluation of the Effectiveness of Single Tufted Brush in the Management of Peri-implant Mucositis in Healthy Individuals: A Randomised Controlled Single Blinded Clinical Trial
The study aims to investigate and compare the reduction in (1) soft tissue inflammation and (2) amount of plaque accumulation at implant sites with (test) or without (control) patient administered use of single tufted brush.
Stratified randomized single blinded clinical controlled trial with 2 parallel arms is designed to achieve the aims of this research project. Study participants will be enrolled from NUH University Dental Cluster. They will be randomly assigned into the test (toothbrush, interdental brush, and single tufted brush) and control (toothbrush and interdental brush) groups and reviewed at 2 weeks (± 3 days), 4 weeks (± 3 days), 3 months (± 7 days), and 6 months (± 7 days).
Read the detailed description
There are two study phases during the whole course of the study. PHASE 1: EXAMINER CALIBRATION Examiner will be calibrated before the study period with 10 volunteers.
The intra-examiner reliability will be assessed using intraclass correlation coefficient. The volunteers will be recruited based on the inclusion and exclusion criteria.
Clinical Parameters:
- Probing pocket depths (PPD) at 6 sites per implant ii. mBI at 6 sites per implant iii. mPI at 8 sites per implant Clinical parameters (i) to (iii) will be performed at day 0 and day 7.
PHASE 2: STUDY INTERVENTION 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 inclusion and exclusion criteria.
Groups:
- Test: Subjects in this group will receive a single tufted brush and interdental brushes of an appropriate size that will fit the interdental spaces around the implant.
- Control: Subjects in this group will only receive interdental brushes.
Randomization:
Study subjects will be randomly assigned into either test or control group based on a computer generated randomization code after screening of inclusion and exclusion criteria and signing of 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.
Clinical Parameters:
- Probing pocket depths (PPD) (6 points per implant) ii. mBI (6 points per implant) iii. mPI (8 points per implant) iv. Characteristics of the implant and implant crown: tissue level or bone level, supraor submucosal margin, degree of overcontour as seen on periapical radiograph v. Peri-apical radiograph of implant taken with parallel technique Clinical parameters (i) to (iii) will be performed at baseline, 2-weeks, 1 month, 3 months, and 6 months post instrumentation.
Clinical parameter (iv) and (v) will be performed at baseline.
Radiographic Analysis:
Peri-apical radiographs will be taken with paralleling technique to determine that there is peri-implant bone loss beyond 2mm at baseline.
- Conditions
- Dental Implant
- Being tested
- single tufted brush with IDB, interdental brushes
- Keywords
- dental implants, tufted brush, IDB, mucositis, gingivitis
- Medical subject headings
- Mucositis, Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single tufted brush with IDBDevice
Subjects in this group will receive a single tufted brush and interdental brushes of an appropriate size that will fit the interdental spaces around the implant.
interdental brushesDevice
Subjects in this group will only receive interdental brushes
| Study group | Role | What they receive |
|---|---|---|
| single tufted brush with IDB | Experimental | Subjects in this group will receive a single tufted brush and interdental brushes of an appropriate size for 6 months. Receives: Device: single tufted brush with IDB |
| interdental brushes | Active comparator | Subjects in this group will only receive interdental brushes 6 months. Receives: Device: interdental brushes |
What is being measured
The primary outcome is the main question the study is designed to answer.
the reduction in bleeding tendency
The reduction in bleeding tendency as assessed by mBI at 6 sites per implant
Measured: baseline, 2-weeks, 1 month, 3 months, and 6 months post instrumentation
Secondary outcomes (1)
the reduction in plaque accumulation
The reduction in plaque accumulation with a modified Plaque Index (mPI) at 8 sites (mesiobuccal, mesial, mesiolingual, lingual, distolingual, distal, distobuccal, and buccal) per implant
Measured: baseline, 2-weeks, 1 month, 3 months, and 6 months post instrumentation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2019
- Study start7 Jun 2019 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 110 participants (estimated)
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
- NCT03872687
- Sponsor's protocol ID
- 2018/01174
- Other IDs
- 2018
- Status last verified
- Mar 2019
- First submitted
- 11 Mar 2019
- 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
- An Evaluation of the Effectiveness of Single Tufted Brush in the Management of Peri-implant Mucositis in Healthy Individuals: A Randomised Controlled Single Blinded Clinical Trial
- ClinicalTrials.gov ID
- NCT03872687
- Acronym / sponsor ID
- 2018/01174
- Conditions
- Dental Implant
- Keywords
- dental implants, tufted brush, IDB, mucositis, gingivitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- National University Health System, SingaporeUniversity, hospital or other
- Study start
- 7 Jun 2019 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 13 Mar 2019 (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.
The study aims to investigate and compare the reduction in (1) soft tissue inflammation and (2) amount of plaque accumulation at implant sites with (test) or without (control) patient administered use of single tufted brush.
Stratified randomized single blinded clinical controlled trial with 2 parallel arms is designed to achieve the aims of this research project. Study participants will be enrolled from NUH University Dental Cluster. They will be randomly assigned into the test (toothbrush, interdental brush, and single tufted brush) and control (toothbrush and interdental brush) groups and reviewed at 2 weeks (± 3 days), 4 weeks (± 3 days), 3 months (± 7 days), and 6 months (± 7 days).
Detailed description
There are two study phases during the whole course of the study. PHASE 1: EXAMINER CALIBRATION Examiner will be calibrated before the study period with 10 volunteers.
The intra-examiner reliability will be assessed using intraclass correlation coefficient. The volunteers will be recruited based on the inclusion and exclusion criteria.
Clinical Parameters:
- Probing pocket depths (PPD) at 6 sites per implant ii. mBI at 6 sites per implant iii. mPI at 8 sites per implant Clinical parameters (i) to (iii) will be performed at day 0 and day 7.
PHASE 2: STUDY INTERVENTION 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 inclusion and exclusion criteria.
Groups:
- Test: Subjects in this group will receive a single tufted brush and interdental brushes of an appropriate size that will fit the interdental spaces around the implant.
- Control: Subjects in this group will only receive interdental brushes.
Randomization:
Study subjects will be randomly assigned into either test or control group based on a computer generated randomization code after screening of inclusion and exclusion criteria and signing of 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.
Clinical Parameters:
- Probing pocket depths (PPD) (6 points per implant) ii. mBI (6 points per implant) iii. mPI (8 points per implant) iv. Characteristics of the implant and implant crown: tissue level or bone level, supraor submucosal margin, degree of overcontour as seen on periapical radiograph v. Peri-apical radiograph of implant taken with parallel technique Clinical parameters (i) to (iii) will be performed at baseline, 2-weeks, 1 month, 3 months, and 6 months post instrumentation.
Clinical parameter (iv) and (v) will be performed at baseline.
Radiographic Analysis:
Peri-apical radiographs will be taken with paralleling technique to determine that there is peri-implant bone loss beyond 2mm at baseline.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| single tufted brush with IDB | Experimental | Device: single tufted brush with IDBSubjects in this group will receive a single tufted brush and interdental brushes of an appropriate size for 6 months. |
| interdental brushes | Active comparator | Device: interdental brushesSubjects in this group will only receive interdental brushes 6 months. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 21-70 years old ii. Medically healthy (ASA I or II) iii. Presence of interdental spaces that will allow an interdental brush to pass through without soft tissue trauma iv. Single moderately rough 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 v. Implants should have peri-implant mucositis that is defined as (Renvert, et al., 2018)
- Presence of clinical signs of inflammation, which are redness, shininess of the soft tissue surface, local swelling, with or without increase in probing depth
- Bleeding on probing
- No progressive peri-implant bone loss beyond 2mm from implant platform (Rosen, et al., 2013) vi. Implants with at least 1mm of keratinized peri-implant mucosa
Key exclusion criteria (1 listed)
- Embrasure space between the implant and adjacent tooth is non-existent or too small to permit the use of an interdental brush ii. Self declared pregnancy iii. Heavy smokers (1 pack a day) iv. Uncontrolled or poorly controlled medical conditions e.g. diabetes (HBA1c 8.5% and above) v. Untreated oral conditions e.g. active periodontitis vi. On medications that will cause gingival enlargement vii. Any hyperplastic interdental papilla that will hinder interdental cleaning viii. Antibiotics intake within the past 3 months ix. Parkinson's disease and other debilitating diseases x. Subjects who are unable to give consent e.g. mentally challenged
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 |
|---|---|---|
| single tufted brush with IDBSubjects in this group will receive a single tufted brush and interdental brushes of an appropriate size that will fit the interdental spaces around the implant. | Device | single tufted brush with IDB |
| interdental brushesSubjects in this group will only receive interdental brushes | Device | interdental brushes |
Primary outcome
the reduction in bleeding tendency
Time frame: baseline, 2-weeks, 1 month, 3 months, and 6 months post instrumentation
The reduction in bleeding tendency as assessed by mBI at 6 sites per implant
1 secondary outcome
the reduction in plaque accumulation
Time frame: baseline, 2-weeks, 1 month, 3 months, and 6 months post instrumentation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2019.
- 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, Master principal investigator
National University Health System, Singapore
Questions about this trial
What is this clinical trial studying?
A study testing single tufted brush with IDB and interdental brushes in people with Dental Implant, 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 4 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: status not confirmed, 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jia Hui Fu, Master (65-6779 5555 ext. 1649, denfjh@nus.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the reduction in bleeding tendency (time frame: baseline, 2-weeks, 1 month, 3 months, and 6 months post instrumentation). 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.