Evaluation of Plaque Removal Efficacy and Patient Acceptability of Knotted Floss Technique in Type I Gingival Embrasures

• Register: ClinicalTrials.gov
• Last refreshed on: 24 October 2016
• Main ID: NCT02931994
• Date of registration: 06/10/2016
• Prospective Registration: No
• Primary sponsor: Uttaranchal Dental & Medical Research Institute
• Public title: Evaluation of Plaque Removal Efficacy and Patient Acceptability of Knotted Floss Technique in Type I Gingival Embrasures Knotfloss-1
• Scientific title: Comparative Evaluation of the Plaque Removal Efficacy and Patient Acceptability of the Knotted Floss Technique With Conventional Flossing Technique in Type I Gingival Embrasures
• Date of first enrolment: April 2015
• Target sample size: 30
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02931994
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
• Phase: N/A

Countries of recruitment

India

Contacts

• Name: Aaron F Gomes, MDS
• Affiliation: Uttaranchal Dental and Medical Research Institute

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Complication of Personal Oral Hygiene

Intervention(s)

Other: Knotted floss technique

Primary Outcome(s)

Barnett's Modified Papillary Bleeding Index - 6weeks [Time Frame: 6 weeks]

Gingival Trauma Index (as described by Carter-Hanson et al 1996)- 6weeks [Time Frame: 6 weeks]

Rustogi modification of Navy Plaque Index - 6weeks [Time Frame: 6 weeks]

Lobene's Modified Gingival Index - 6weeks [Time Frame: 6 weeks]

Secondary Outcome(s)

Gingival Trauma Index (as described by Carter-Hanson et al 1996) - 2 weeks [Time Frame: 2 weeks]

Gingival Trauma Index (as described by Carter-Hanson et al 1996) - baseline [Time Frame: baseline]

Lobene's Modified Gingival Index - 2 weeks [Time Frame: 2 weeks]

Lobene's Modified Gingival Index - baseline [Time Frame: baseline]

Rustogi modification of Navy Plaque Index - 4 weeks [Time Frame: 4 weeks]

Barnett's Modified Papillary Bleeding Index - 4 weeks [Time Frame: 4 weeks]

Gingival Trauma Index (as described by Carter-Hanson et al 1996) - 4 weeks [Time Frame: 4 weeks]

Lobene's Modified Gingival Index - 4 weeks [Time Frame: 4 weeks]

Rustogi modification of Navy Plaque Index - baseline [Time Frame: baseline]

Barnett's Modified Papillary Bleeding Index - baseline [Time Frame: baseline]

Rustogi modification of Navy Plaque Index - 2 weeks [Time Frame: 2 weeks]

Barnett's Modified Papillary Bleeding Index - 2 weeks [Time Frame: 2 weeks]

Secondary ID(s)

UTN U1111-1188-4175

UttaranchalDMRI

Source(s) of Monetary Support

Please refer to primary and secondary sponsors