Trial Outcomes & Findings for Comparison of Modified Circular and Natural Tooth Brushing Methods in Effectiveness of Dental Plaque Removal (NCT NCT03547531)

Results Overview

Plaque level is examined using "Turesky Modification of Quigley-Hein Index". The scale is ranged from 0 to 5. 0 means no dental plaque existed on the tooth surface. 5 means all of the tooth surface is covered by dental plaque from the area that is closest to gingival to the occlusal area. The higher number of scores means worse. This index examines the buccal and lingual/palatal surfaces of the teeth (each teeth examined in 2 surfaces).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

124 participants

Primary outcome timeframe

Baseline

Results posted on

2019-08-05

Participant Flow

All of the participants were fifth graders from 2 elementary schools in Yogyakarta, Indonesia. These two schools have the similar characteristics in social-economy, number of students, and the type of school based on the data and recommendation from Education and Culture Office of Sleman District, Yogyakarta, Indonesia.

Each school had 62 fifth graders (total participants of both school was 124 fifth graders). No participants were excluded. Random group assignment was done by coin flipping to choose one school as control group and the other as intervention group.

Participant milestones

Participant milestones
Measure	Natural Tooth Brushing Method Natural tooth brushing method is the method that is naturally used by the people with horizontal, rotary, or simple up and down motions and any position of the brush without any instruction of particular tooth brushing method. Natural Tooth Brushing Method: Natural tooth brushing method is the method that is naturally used by the people with horizontal, rotary, or simple up and down motions and any position of the brush without any instruction of particular tooth brushing method.	Modified Circular Tooth Brushing Method Modified Circular tooth brushing method is a combination of small circular motion of brushing with the position of the brush slightly reach underneath the gingival that are applied for each jaw in all facial surfaces and posterior lingual of tooth arches. Modified Circular Tooth Brushing Method: Modified Circular tooth brushing method is a combination of small circular motion of brushing with the position of the brush slightly reach underneath the gingival that are applied for each jaw in all facial surfaces and posterior lingual of tooth arches.
Overall Study STARTED	62	62
Overall Study COMPLETED	60	58
Overall Study NOT COMPLETED	2	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Natural Tooth Brushing Method Natural tooth brushing method is the method that is naturally used by the people with horizontal, rotary, or simple up and down motions and any position of the brush without any instruction of particular tooth brushing method. Natural Tooth Brushing Method: Natural tooth brushing method is the method that is naturally used by the people with horizontal, rotary, or simple up and down motions and any position of the brush without any instruction of particular tooth brushing method.	Modified Circular Tooth Brushing Method Modified Circular tooth brushing method is a combination of small circular motion of brushing with the position of the brush slightly reach underneath the gingival that are applied for each jaw in all facial surfaces and posterior lingual of tooth arches. Modified Circular Tooth Brushing Method: Modified Circular tooth brushing method is a combination of small circular motion of brushing with the position of the brush slightly reach underneath the gingival that are applied for each jaw in all facial surfaces and posterior lingual of tooth arches.
Overall Study not coming in data collection : sick	2	2
Overall Study having family occasion	0	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Natural Tooth Brushing Method n=1326 Number of teeth Natural tooth brushing method is the method that is naturally used by the people with horizontal, rotary, or simple up and down motions and any position of the brush without any instruction of particular tooth brushing method. Natural Tooth Brushing Method: Natural tooth brushing method is the method that is naturally used by the people with horizontal, rotary, or simple up and down motions and any position of the brush without any instruction of particular tooth brushing method.	Modified Circular Tooth Brushing Method n=1328 Number of teeth Modified Circular tooth brushing method is a combination of small circular motion of brushing with the position of the brush slightly reach underneath the gingival that are applied for each jaw in all facial surfaces and posterior lingual of tooth arches. Modified Circular Tooth Brushing Method: Modified Circular tooth brushing method is a combination of small circular motion of brushing with the position of the brush slightly reach underneath the gingival that are applied for each jaw in all facial surfaces and posterior lingual of tooth arches.	Total n=2654 Number of teeth Total of all reporting groups
Age, Customized Age of participants	10.9 years STANDARD_DEVIATION 0.379 • n=62 Participants	10.8 years STANDARD_DEVIATION 0.342 • n=62 Participants	10.8 years STANDARD_DEVIATION 0.365 • n=124 Participants
Sex: Female, Male Female	36 Participants n=62 Participants	34 Participants n=62 Participants	70 Participants n=124 Participants
Sex: Female, Male Male	26 Participants n=62 Participants	28 Participants n=62 Participants	54 Participants n=124 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Indonesia	62 Participants n=62 Participants	62 Participants n=62 Participants	124 Participants n=124 Participants

PRIMARY outcome

Timeframe: Baseline

Plaque level is examined using "Turesky Modification of Quigley-Hein Index". The scale is ranged from 0 to 5. 0 means no dental plaque existed on the tooth surface. 5 means all of the tooth surface is covered by dental plaque from the area that is closest to gingival to the occlusal area. The higher number of scores means worse. This index examines the buccal and lingual/palatal surfaces of the teeth (each teeth examined in 2 surfaces).

Outcome measures

Outcome measures
Measure	Natural Tooth Brushing Method n=2652 Number of teeth surfaces Natural tooth brushing method is the method that is naturally used by the people with horizontal, rotary, or simple up and down motions and any position of the brush without any instruction of particular tooth brushing method. Natural Tooth Brushing Method: Natural tooth brushing method is the method that is naturally used by the people with horizontal, rotary, or simple up and down motions and any position of the brush without any instruction of particular tooth brushing method.	Modified Circular Tooth Brushing Method n=2656 Number of teeth surfaces Modified Circular tooth brushing method is a combination of small circular motion of brushing with the position of the brush slightly reach underneath the gingival that are applied for each jaw in all facial surfaces and posterior lingual of tooth arches. Modified Circular Tooth Brushing Method: Modified Circular tooth brushing method is a combination of small circular motion of brushing with the position of the brush slightly reach underneath the gingival that are applied for each jaw in all facial surfaces and posterior lingual of tooth arches.
Baseline Plaque Level	2.25 plaque index Standard Deviation 0.65	2.28 plaque index Standard Deviation 1.68

PRIMARY outcome

Timeframe: Baseline

The examination of gingival condition was using the Gingival Index by Silness and Loe. A score between 0 and 3 was given based on the criteria: 0= Normal gingiva. 1. Mild inflammation - slight change in color, slight edema. No bleeding on probing. 2. Moderate inflammation - redness, edema and glazing. Bleeding on probing. 3. Severe inflammation - marked redness and edema. Ulceration. Tendency to spontaneous bleeding. This scale examine each teeth in 4 surfaces (mesial, distal, buccal, lingual/palatal).

Outcome measures

Outcome measures
Measure	Natural Tooth Brushing Method n=5304 Number of teeth surfaces Natural tooth brushing method is the method that is naturally used by the people with horizontal, rotary, or simple up and down motions and any position of the brush without any instruction of particular tooth brushing method. Natural Tooth Brushing Method: Natural tooth brushing method is the method that is naturally used by the people with horizontal, rotary, or simple up and down motions and any position of the brush without any instruction of particular tooth brushing method.	Modified Circular Tooth Brushing Method n=5312 Number of teeth surfaces Modified Circular tooth brushing method is a combination of small circular motion of brushing with the position of the brush slightly reach underneath the gingival that are applied for each jaw in all facial surfaces and posterior lingual of tooth arches. Modified Circular Tooth Brushing Method: Modified Circular tooth brushing method is a combination of small circular motion of brushing with the position of the brush slightly reach underneath the gingival that are applied for each jaw in all facial surfaces and posterior lingual of tooth arches.
Baseline Gingival Condition	0.51 gingival index Standard Deviation 0.28	0.49 gingival index Standard Deviation 0.40

PRIMARY outcome

Timeframe: one month after baseline data collection

Plaque level is examined using "Turesky Modification of Quigley-Hein Index". The scale is ranged from 0 to 5. 0 means no dental plaque existed on the tooth surface. 5 means all of the tooth surface is covered by dental plaque from the area that is closest to gingival to the occlusal area. The higher number of scores means worse. This index examines the buccal and lingual/palatal surfaces of the teeth (each teeth examined in 2 surfaces).

Outcome measures

Outcome measures
Measure	Natural Tooth Brushing Method n=2564 Number of teeth surfaces Natural tooth brushing method is the method that is naturally used by the people with horizontal, rotary, or simple up and down motions and any position of the brush without any instruction of particular tooth brushing method. Natural Tooth Brushing Method: Natural tooth brushing method is the method that is naturally used by the people with horizontal, rotary, or simple up and down motions and any position of the brush without any instruction of particular tooth brushing method.	Modified Circular Tooth Brushing Method n=2488 Number of teeth surfaces Modified Circular tooth brushing method is a combination of small circular motion of brushing with the position of the brush slightly reach underneath the gingival that are applied for each jaw in all facial surfaces and posterior lingual of tooth arches. Modified Circular Tooth Brushing Method: Modified Circular tooth brushing method is a combination of small circular motion of brushing with the position of the brush slightly reach underneath the gingival that are applied for each jaw in all facial surfaces and posterior lingual of tooth arches.
Plaque Level at 1 Month	2.28 plaque index Standard Deviation 1.19	1.68 plaque index Standard Deviation 1.08

PRIMARY outcome

Timeframe: one month after baseline data collection

The examination of gingival condition was using the Gingival Index by Silness and Loe. A score between 0 and 3 was given based on the criteria: 0= Normal gingiva. 1. Mild inflammation - slight change in color, slight edema. No bleeding on probing. 2. Moderate inflammation - redness, edema and glazing. Bleeding on probing. 3. Severe inflammation - marked redness and edema. Ulceration. Tendency to spontaneous bleeding. This scale examine each teeth in 4 surfaces (mesial, distal, buccal, lingual/palatal).

Outcome measures

Outcome measures
Measure	Natural Tooth Brushing Method n=5128 number of teeth surfaces Natural tooth brushing method is the method that is naturally used by the people with horizontal, rotary, or simple up and down motions and any position of the brush without any instruction of particular tooth brushing method. Natural Tooth Brushing Method: Natural tooth brushing method is the method that is naturally used by the people with horizontal, rotary, or simple up and down motions and any position of the brush without any instruction of particular tooth brushing method.	Modified Circular Tooth Brushing Method n=4976 number of teeth surfaces Modified Circular tooth brushing method is a combination of small circular motion of brushing with the position of the brush slightly reach underneath the gingival that are applied for each jaw in all facial surfaces and posterior lingual of tooth arches. Modified Circular Tooth Brushing Method: Modified Circular tooth brushing method is a combination of small circular motion of brushing with the position of the brush slightly reach underneath the gingival that are applied for each jaw in all facial surfaces and posterior lingual of tooth arches.
Gingival Condition at 1 Month	0.49 gingival index Standard Deviation 0.40	0.28 gingival index Standard Deviation 0.33

Adverse Events

Natural Tooth Brushing Method

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Modified Circular Tooth Brushing Method

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

istiyanti Hapsari

Prince of Songkla University

Phone: +66980493996

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place