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

NCT03414073 | Completed DMC

• 1 other identifier: UttaranchalDMRI_KF-II
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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 endeavors of mechanical plaque removal, tooth-brushing and use of dental floss play an important role. Gomes et al have presented a modification in the use of knotted floss in wider embrasure areas. The modification in the dental floss has been done so as to increase the effective width of the floss. The purpose of this study is to compare the reduction of the clinical signs of plaque accumulation, gingival inflammation, gingival bleeding and gingival trauma in the area the knotted floss technique has been utilized versus the area where conventional flossing or interdental brush has been utilized in Type II gingival embrasures. Patients' acceptability of the knotted flossing technique will also be evaluated.

Conditions

Oral Hygiene; Dental Devices, Home Care

Keywords

dental floss; gingival embrasure; oral hygiene; interdental brush

Outcome Measures

Primary Outcomes (4)

• Rustogi modification of Navy Plaque Index - 4-weeks

  Rustogi modification of Navy Plaque Index will be assessed at 4-weeks for all subjects in Group A Phase 1, Group B Phase 1, Group C Phase 1, Group A Phase 2, Group B Phase 2, Group C Phase 2, Group A Phase 3, Group B Phase 3 and Group C Phase 3

  4 weeks

• Lobene's Modified Gingival Index - 4-weeks

  Lobene's Modified Gingival Index will be assessed at 4-weeks for all subjects in Group A Phase 1, Group B Phase 1, Group C Phase 1, Group A Phase 2, Group B Phase 2, Group C Phase 2, Group A Phase 3, Group B Phase 3 and Group C Phase 3

  4 weeks

• Barnett's Modified Papillary Bleeding Index - 4 Weeks

  Barnett's Modified Papillary Bleeding Index will be assessed at 4-weeks for all subjects in Group A Phase 1, Group B Phase 1, Group C Phase 1, Group A Phase 2, Group B Phase 2, Group C Phase 2, Group A Phase 3, Group B Phase 3 and Group C Phase 3

  4 weeks

• Gingival Trauma Index (as Described by Carter-Hanson et al 1996) - 4-weeks

  Gingival Trauma Index (as Described by Carter-Hanson et al 1996) will be assessed at 4-weeks for all subjects in Group A Phase 1, Group B Phase 1, Group C Phase 1, Group A Phase 2, Group B Phase 2, Group C Phase 2, Group A Phase 3, Group B Phase 3 and Group C Phase 3

  4 weeks

Secondary Outcomes (8)

• Rustogi modification of Navy Plaque Index - Baseline

  Baseline

• Lobene's Modified Gingival Index - baseline

  baseline

• Barnett's Modified Papillary Bleeding Index - baseline

  baseline

• Gingival Trauma Index (as Described by Carter-Hanson et al 1996) - baseline

  baseline

• Rustogi Modification of Navy Plaque Index - 2 Weeks

  2 weeks

Study Arms (9)

Group A Phase 1

SHAM COMPARATOR

Conventional flossing technique using commercially available Reach® Floss One third of sample are randomly assigned to Group A and are to utilise conventional finger flossing technique in the first phase of 4-weeks. For the conventional flossing technique the subjects will wrap the floss around their middle or index finger and gently slide the floss between the teeth and move it along the gum margin, curved into "C" shape. After this, they will have to move the floss up and down several times between each tooth without using excessive pressure, finally allowing it out through embrasure.

Device: Conventional flossing technique

Group B Phase 1

ACTIVE COMPARATOR

Knotted floss technique using an improvised flossing technique by putting a knot in commercially available Reach® Floss One third of sample are randomly assigned to Group B and are to utilise knotted floss technique in the first phase of 4-weeks, twice daily. The subjects will use the supplied floss lengths having a simple knot in the middle and will perform the same way as the conventional finger flossing technique, except that the insertion of floss will have to be in the non-knotted area and during the to and fro movements the knotted area of the floss will have to be engaged in the interdental area.

Device: Knotted floss technique

Group C Phase 1

SHAM COMPARATOR

Conventional interdental brushing technique using Thermoseal® Proxa ns interdental brushes One third of sample are randomly assigned to Group C and are to utilise conventional interdental brushing technique in the first phase of 4-weeks twice daily. The subjects will gently insert the brush into the interdental area with an inclination akin to the angle of the interdental gums (gingiva), and perform to and fro buccal to lingual movements and a little apico-coronal movement such that the gingiva is not impinged, and finally removing the brush out buccally.

Device: Conventional Interdental Brushing

Group A Phase 2

ACTIVE COMPARATOR

Knotted floss technique using an improvised flossing technique by putting a knot in commercially available Reach® Floss After a washout period of 2 weeks, those from Group A will use the knotted floss technique in the second phase for a period of 4 weeks, twice daily. The subjects will use the supplied floss lengths having a simple knot in the middle and will perform the same way as the conventional finger flossing technique, except that the insertion of floss will have to be in the non-knotted area and during the to and fro movements the knotted area of the floss will have to be engaged in the interdental area.

Device: Knotted floss technique

Group B Phase 2

SHAM COMPARATOR

Conventional interdental brushing technique using Thermoseal® Proxa ns interdental brushes After a washout period of 2 weeks, those from Group B will use the conventional interdental brushing technique in the second phase for a period of 4 weeks, twice daily. The subjects will gently insert the brush into the interdental area with an inclination akin to the angle of the interdental gums (gingiva), and perform to and fro buccal to lingual movements and a little apico-coronal movement such that the gingiva is not impinged, and finally removing the brush out buccally.

Device: Conventional Interdental Brushing

Group C Phase 2

SHAM COMPARATOR

Conventional flossing technique using commercially available Reach® Floss After a washout period of 2 weeks, those from Group C will use the conventional finger flossing technique in the second phase for a period of 4 weeks, twice daily. For the conventional flossing technique the subjects will wrap the floss around their middle or index finger and gently slide the floss between the teeth and move it along the gum margin, curved into "C" shape. After this, they will have to move the floss up and down several times between each tooth without using excessive pressure, finally allowing it out through embrasure.

Device: Conventional flossing technique

Group A Phase 3

SHAM COMPARATOR

Conventional interdental brushing technique using Thermoseal® Proxa ns interdental brushes After a washout period of 2 weeks, those from Group A will use the conventional interdental brushing technique in the third phase for a period of 4 weeks, twice daily. The subjects will gently insert the brush into the interdental area with an inclination akin to the angle of the interdental gums (gingiva), and perform to and fro buccal to lingual movements and a little apico-coronal movement such that the gingiva is not impinged, and finally removing the brush out buccally.

Device: Conventional Interdental Brushing

Group B Phase 3

SHAM COMPARATOR

Conventional flossing technique using commercially available Reach® Floss After a washout period of 2 weeks, those from Group B will use the conventional finger flossing technique in the third phase for a period of 4 weeks, twice daily. For the conventional flossing technique the subjects will wrap the floss around their middle or index finger and gently slide the floss between the teeth and move it along the gum margin, curved into "C" shape. After this, they will have to move the floss up and down several times between each tooth without using excessive pressure, finally allowing it out through embrasure.

Device: Conventional flossing technique

Group C Phase 3

ACTIVE COMPARATOR

Knotted floss technique using an improvised flossing technique by putting a knot in commercially available Reach® Floss After a washout period of 2 weeks, those from Group C will use the knotted floss technique in the third phase for a period of 4 weeks, twice daily. The subjects will use the supplied floss lengths having a simple knot in the middle and will perform the same way as the conventional finger flossing technique, except that the insertion of floss will have to be in the non-knotted area and during the to and fro movements the knotted area of the floss will have to be engaged in the interdental area.

Device: Knotted floss technique

Interventions

Knotted floss technique DEVICE

The subjects use the knotted floss technique. In this modification of conventional flossing technique, a knot is tied in the floss at any distance in the middle third of the floss length. The floss is inserted past the interdental contact point by the conventional finger flossing technique in the non-knotted area and then during the 'to and fro movement' on the tooth surface cervical to contact point, the knotted area is engaged through the embrasure (Gomes et al 2016)

Group A Phase 2; Group B Phase 1; Group C Phase 3

Conventional flossing technique DEVICE

The subject will wrap the floss around their middle or index finger and gently slide the floss between the teeth and move it along the gum margin, curved into "C" shape. After this, they will have to move the floss up and down several times between each tooth without using excessive pressure, finally allowing it out through embrasure.

Also known as: Finger Flossing, Conventional finger flossing technique

Group A Phase 1; Group B Phase 3; Group C Phase 2

Conventional Interdental Brushing DEVICE

The subject will gently insert the interdental brush into the interdental area with an inclination akin to the angle of the interdental gums (gingiva), and perform to and fro buccal to lingual movements and a little apico-coronal movement such that the gingiva is not impinged, and finally removing the brush out buccally.

Also known as: Interdental Brushes for interproximal cleaning

Group A Phase 3; Group B Phase 2; Group C Phase 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Uttaranchal Dental & Medical Research Institute: lead

Study Sites (1)

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

Dehradun, Uttarakhand, 248140, India

Location

Related Publications (24)

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  PMID: 5289846 BACKGROUND

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• Anerud A, Loe H, Boysen H, Smith M. The natural history of periodontal disease in man. Changes in gingival health and oral hygiene before 40 years of age. J Periodontal Res. 1979 Nov;14(6):526-40. doi: 10.1111/j.1600-0765.1979.tb00255.x. No abstract available.

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  BACKGROUND

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• Schmid M. Plaque control. In: Carranza F, editor. Glickman's clinical periodontology. 6th ed. Philadelphia: W.B Saunders Company; 1984:689-690.

  BACKGROUND

• Carr MP, Rice GL, Horton JE. Evaluation of floss types for interproximal plaque removal. Am J Dent. 2000 Aug;13(4):212-4.

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  BACKGROUND

• Gomes AF, Meru S, Rekhi A. Knotted floss technique. J Advanced Res Dent Oral Health 2016;1(1):6-7.

  BACKGROUND

• Gomes AF, Rekhi A, Meru S, Chahal G. Evaluation of plaque removal efficacy and patient acceptability of knotted floss technique in type I gingival embrasures. U.S. National Library of Medicine. ClinicalTrials.gov identifier: NCT02931994. Available at: https://clinicaltrials.gov/ct2/show/NCT02931994.htm.

  BACKGROUND

• SILNESS J, LOE H. PERIODONTAL DISEASE IN PREGNANCY. II. CORRELATION BETWEEN ORAL HYGIENE AND PERIODONTAL CONDTION. Acta Odontol Scand. 1964 Feb;22:121-35. doi: 10.3109/00016356408993968. No abstract available.

  PMID: 14158464 BACKGROUND

• LOE H, SILNESS J. PERIODONTAL DISEASE IN PREGNANCY. I. PREVALENCE AND SEVERITY. Acta Odontol Scand. 1963 Dec;21:533-51. doi: 10.3109/00016356309011240. No abstract available.

  PMID: 14121956 BACKGROUND

• Adwazi K, Crawley F, Idänpään-Heikkilä JE, et al. World Health Organization. Handbook for good clinical research practice (GCP): guidance for implementation. WHO Library Cataloguing-in-Publication Data. France. 2005. Available at http://apps.who.int/medicinedocs/pdf/whozip13e/whozip13e.pdf. Accessed April 6, 2015.

  BACKGROUND

• Rustogi KN, Curtis JP, Volpe AR, Kemp JH, McCool JJ, Korn LR. Refinement of the Modified Navy Plaque Index to increase plaque scoring efficiency in gumline and interproximal tooth areas. J Clin Dent. 1992;3(Suppl C):C9-12.

  PMID: 1306676 BACKGROUND

• Lobene RR, Weatherford T, Ross NM, Lamm RA, Menaker L. A modified gingival index for use in clinical trials. Clin Prev Dent. 1986 Jan-Feb;8(1):3-6. No abstract available.

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• Barnett M, Ciancio S, Mather M. The modified papillary bleeding index: comparison with gingival index during the resolution of gingivitis. J Prev Dent 1980; 6:135-138.

  BACKGROUND

• Gomes AF, S M, Rekhi A. Letter to the Editor: Re: Reducing Dental Plaque and Gingivitis With 0.6% Cortex Ilicis Rotundae Toothpaste: A Randomized, Double-Masked Clinical Trial. J Periodontol. 2017 Jan;88(1):1. doi: 10.1902/jop.2016.160513. Epub 2016 Nov 4. No abstract available.

  PMID: 27809632 BACKGROUND

Study Officials

• Aaron F Gomes, MDS

  Uttaranchal Dental & Medical Research Institute, Dehradun, India

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Only the Principal investigator will know the intervention being done by subject. The outcome investigator(assessor) will be unaware (blinded) to which intervention the subject is undertaken
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof & Head, Dept of Periodontics & Oral Implantology

Model Details: Subjects will be randomly allotted to three groups. each group will undergo three treatment phases with an in-between washout phase.In each treatment phase the group subjects will test a different intervention

Study Record Dates

• First Submitted: January 20, 2018
• First Posted: January 29, 2018
• Study Start: February 5, 2018
• Primary Completion: March 20, 2018
• Study Completion: June 24, 2018
• Last Updated: December 6, 2018

Record last verified: 2018-12

Locations

IN (1)