Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 12:01 AM
NCT ID:
NCT03575858
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
80 Years
Study:
NCT03575858
Study Brief:
Protocol Section:
NCT03575858