Dental Implants, Single-Tooth Clinical Trial
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
Verified date | March 2019 |
Source | National University Health System, Singapore |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 31, 2020 |
Est. primary completion date | December 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 80 Years |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 - Any hyperplastic interdental papilla that will hinder interdental cleaning - Antibiotics intake within the past 3 months - Parkinson's disease and other debilitating diseases |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
National University Health System, Singapore |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Baseline, 2-week and 4-week |
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