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 @ 1:45 AM
Ignite Modification Date:
2025-12-25 @ 1:45 AM
NCT ID:
NCT02931994
Eligibility Criteria:
Inclusion Criteria:
* have one type I gingival embrasure in the premolar first molar area.
* full mouth Plaque Index score ≥1.8 (Silness and Loe 1964)
* full mouth Gingival Index ≥ 1.0 (Loe and Silness 1963)
* good general health,
* have all teeth present in quadrant being tested and opposing quadrant
* be available for a 14 week study period,
* be ready to abide with the study criteria,
* minimum education of grade 12
Exclusion Criteria:
* have used in previous 2months oral hygiene aids other than tooth-brushing like dental flossing, mouthwashes and water jet irrigating systems
* habit of unilateral mastication for ≥2 months,
* medical history of diabetes mellitus, hepatitis, pregnancy or requiring any antibiotic prophylaxis,
* having drug history in preceding two months of use of antibiotics, hormonal supplements, steroids, non steroidal anti-inflammatory medications, oral contraceptives or any drug that influence gingival tissue,
* taking part in any other clinical or drug trial including taking part in other study groups related to the evaluation of knotted floss technique,
* having physical handicap limiting the ability for oral hygiene and effective use of dental floss,
* had orthodontic treatment
* having gross dental caries
* having advanced periodontitis (more than one pocket ≥ 6mm),
* had active periodontal treatment like scaling, root planing, curettage, periodontal surgery in the previous 8weeks,
* had any adverse oral habit like smoking, tobacco chewing or habits of self gingival mutilation,
* had history of trauma or surgery to the jaws.
* teeth adjacent to the embrasure area selected are having proximal caries or gross occlusal caries, or having proximal restorations, crowns, onlays or inlays.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02931994
Study Brief:
Protocol Section:
NCT02931994