Status:

COMPLETED

Evaluation of Plaque Removal Efficacy & Patient Acceptability of Knotted Floss Technique in Type II Gingival Embrasures

Lead Sponsor:

Uttaranchal Dental & Medical Research Institute

Conditions:

Oral Hygiene

Dental Devices, Home Care

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

Removal and prevention of formation of dental plaque biofilms is the cornerstone of current hygiene regimens to prevent, reduce or even reverse the gingival and periodontal disease condition. In such ...

Detailed Description

Substantial evidence exists that show that effective plaque control leads to reduction in prevalence and severity of gingival inflammation. Use of toothbrush with dentifrice is a common mean for remov...

Eligibility Criteria

Inclusion

  • have one Type II 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 16 week study period,
  • be ready to abide with the study criteria,
  • minimum education of grade 12

Exclusion

  • have used in previous 2-months 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 8-weeks,
  • 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.

Key Trial Info

Start Date :

February 5 2018

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 24 2018

Estimated Enrollment :

45 Patients enrolled

Trial Details

Trial ID

NCT03414073

Start Date

February 5 2018

End Date

June 24 2018

Last Update

December 6 2018

Active Locations (1)

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1

Dept of Periodontics & Oral Implantology; Uttaranchal Dental and Medical Reserach Institute

Dehradun, Uttarakhand, India, 248140