The Effectiveness of Single Tufted Brush in the Management of Peri-implant Mucositis
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|ClinicalTrials.gov Identifier: NCT03872687|
Recruitment Status : Not yet recruiting
First Posted : March 13, 2019
Last Update Posted : March 13, 2019
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).
|Condition or disease||Intervention/treatment||Phase|
|Dental Implant||Device: single tufted brush with IDB Device: interdental brushes||Not Applicable|
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.
i. 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.
- 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.
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.
i. 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.
Peri-apical radiographs will be taken with paralleling technique to determine that there is peri-implant bone loss beyond 2mm at baseline.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||110 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
|Estimated Study Start Date :||June 7, 2019|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2020|
Experimental: single tufted brush with IDB
Subjects in this group will receive a single tufted brush and interdental brushes of an appropriate size for 6 months.
Device: single tufted brush with IDB
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.
Active Comparator: interdental brushes
Subjects in this group will only receive interdental brushes 6 months.
Device: interdental brushes
Subjects in this group will only receive interdental brushes
- 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
- the reduction in plaque accumulation [ Time Frame: baseline, 2-weeks, 1 month, 3 months, and 6 months post instrumentation ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03872687
|Contact: Jia Hui Fu, Master||65-6779 5555 ext firstname.lastname@example.org|
|Principal Investigator:||Jia Hui Fu, Master||National University Health System, Singapore|