Comparative Evaluation of the Plaque Removal Efficacy and Patient Acceptability of the Knotted Floss Technique With Conventional Flossing Technique and Interdental Brushing in Type II Gingival Embrasures - A Clinical Crossover Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Barnett's Modified Papillary Bleeding Index - 4 Weeks
Study Overview
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.
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 removing plaque on many tooth surfaces, research has shown that it cannot completely clean the interdental surfaces when used without other interproximal aids. Dental flossing is useful in cleaning interproximal surfaces of teeth from the contact point to the sulcus especially in Type I interdental embrasures. Interdental brushes are used by patients with sufficient space between their teeth or the Type II interdental embrasures. To make the dental floss effective in wide embrasure areas Gomes et al, have recently presented a modification in the technique of flossing and called it the 'Knotted Floss Technique'. Unpublished data by the same authors in a crossover study shows that knotted floss technique is equally safe and effective method for reducing plaque, inflammation and bleeding when compared to conventional finger flossing in Type I gingival embrasures.
The purpose of this study is to compare the reduction of the clinical signs of plaque accumulation, gingival inflammation and gingival trauma in type II gingival embrasures that the knotted floss technique has been used with similar embrasures that a conventional flossing technique has been used, as well as with identical type embrasures wherein an inter-dental brush has been utilized. Patients' acceptability of the knotted flossing technique will also be evaluated.
Materials and Methods:
Criteria for Sample Selection: For this triple phase, examiner blind, crossover clinical trial, a sample size of thirty individuals who were eighteen years and above will be randomly selected from the outpatients of the Department of Periodontology and Oral Implantology at the college hospital. The inclusion and exclusion criteria will be as described later. The trial will be conducted as per the guidelines in the WHO-Handbook for Good Clinical Practice and the research protocol is approved by the Institutional Ethics Committee of the college.
Design of Study: A sample size of thirty subjects will be selected based on the criteria above. Prior to commencement of the actual study, each volunteer will receive written and verbal instructions on the two techniques. Investigator 1 & 3 will demonstrate to the volunteers all 3-techniques on models, for ½hour counseling session, for 3 consecutive days. Each counseling session will have not more than 10 participants. The techniques demonstrated on models will be conventional finger flossing, knotted floss technique and cleaning of interdental area with interdental brush. The conventional finger flossing technique will be demonstrated to the volunteers as follows: to 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. For the knotted floss technique, the volunteers 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. When using the interdental brush, the volunteers will be demonstrated to 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. On the 4th day, after both investigators will be separately satisfied with the volunteer's proficiency on models, with respect to each of the three techniques demonstrated, an informed consent will be taken and the volunteer will be enrolled as a subject into the 16-week, 3-phase crossover, single (examiner) blind study protocol with washout phases of 2-weeks each in-between the intervention phases. Failure by the volunteer to perform the techniques as instructed will mean another counseling session of 1-hour, followed by another check of proficiency by volunteer on models by the above investigators on subsequent day. If the investigators are not satisfied with the ability of the volunteer to perform any one of the 3 demonstrated techniques of interdental cleansing even after an extra counselling session, then the volunteer will not be recruited into the study protocol.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Masking Description
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
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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 Criteria
- •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.
Arms & Interventions
Group A Phase 1
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.
Intervention: Conventional flossing technique (Device)
Group B Phase 1
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.
Intervention: Knotted floss technique (Device)
Group C Phase 1
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.
Intervention: Conventional Interdental Brushing (Device)
Group A Phase 2
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.
Intervention: Knotted floss technique (Device)
Group B Phase 2
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.
Intervention: Conventional Interdental Brushing (Device)
Group C Phase 2
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.
Intervention: Conventional flossing technique (Device)
Group A Phase 3
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.
Intervention: Conventional Interdental Brushing (Device)
Group B Phase 3
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.
Intervention: Conventional flossing technique (Device)
Group C Phase 3
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.
Intervention: Knotted floss technique (Device)
Outcomes
Primary Outcomes
Barnett's Modified Papillary Bleeding Index - 4 Weeks
Time Frame: 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
Lobene's Modified Gingival Index - 4-weeks
Time Frame: 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
Rustogi modification of Navy Plaque Index - 4-weeks
Time Frame: 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
Gingival Trauma Index (as Described by Carter-Hanson et al 1996) - 4-weeks
Time Frame: 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
Secondary Outcomes
- Lobene's Modified Gingival Index - 2-weeks(2 weeks)
- Rustogi modification of Navy Plaque Index - Baseline(Baseline)
- Gingival Trauma Index (as Described by Carter-Hanson et al 1996) - 2-weeks(2 weeks)
- Rustogi Modification of Navy Plaque Index - 2 Weeks(2 weeks)
- 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)
- Barnett's Modified Papillary Bleeding Index - 2 Weeks(2 weeks)
Investigators
Aaron Gomes
Prof & Head, Dept of Periodontics & Oral Implantology
Uttaranchal Dental & Medical Research Institute