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Trial registered on ANZCTR


Registration number
ACTRN12625000213448
Ethics application status
Approved
Date submitted
27/12/2024
Date registered
21/02/2025
Date last updated
21/02/2025
Date data sharing statement initially provided
21/02/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness of three manual toothbrushes with different bristle designs in terms of plaque removal and gingival inflammation-A Randomized Controlled Trial
Scientific title
Effectiveness of three manual toothbrushes with different bristle designs in terms of plaque removal and gingival inflammation-A Randomized Controlled Trial
Secondary ID [1] 313614 0
(npctr.nhrc.gov.np) Nepal clinical Trial Registry (Ref no. 2021/04/000069) and Trial No.: NPCTR2021000616.
Secondary ID [2] 313615 0
B.P. Koirala Institute of Health Sciences, Dharan Nepal (Ref. No. 278/077/078-IRC) with Code no. of IRC/1864/020
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gingival inflammation 336160 0
plaque 336161 0
Condition category
Condition code
Oral and Gastrointestinal 332712 332712 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 332908 332908 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In this study three manual toothbrushes were distributed to each individual on baseline( day 0 )
The toothbrushes were of same company i; e Oral B and all were of soft bristle type. The toothbrushes were:
i) Oral B Pro Health- Crisscross bristle designed toothbrush
ii) Oral B Shiny Clean - Zigzag bristle designed toothbrush
iii) Oral-B-Sensitive Care - Flat bristle designed toothbrush
With toothbrushes a fluoridated toothpaste was also distributed i.e., Closeup
Triple formula anti-germ gel toothpaste red hot-80 gm at the baseline of the study. The overall mean scores of Plaque Index and Gingival index were measured at baseline, 7, 14 and 21 days.
Participants were separated in three groups and each group had only received one of the three toothbrush.
Participants were instructed to use one type of toothbrush for 21 days, twice a day for 2 minutes. for the adherence or compliance, participants were monitored time to time in brushing time by an individual other than the researcher herself.
Intervention code [1] 330211 0
Prevention
Intervention code [2] 330353 0
Treatment: Devices
Comparator / control treatment
Oral-B-Sensitive Care - Flat bristle designed toothbrush is control group
Control group
Active

Outcomes
Primary outcome [1] 340436 0
1. Mean score of plague
Timepoint [1] 340436 0
After randomization, all 105 participants were divided into 7 groups(7*15) so that data collection would be easier. Fifteen participants were called and baseline (day 0) data collection done and toothbrushes were distributed. Same was done for remaining participant on the remaining days of week. Next week after 7 days, same 15 participants were recalled on the same day for data collection. This was done for every 15 participants of the other 6 groups also. Again after 14 and 21 days data was collected.
Primary outcome [2] 340437 0
2. mean score in Gingival inflammation
Timepoint [2] 340437 0
After randomization, all 105 participants were divided into 7 groups(7*15) so that data collection would be easier. Fifteen participants were called and baseline (day 0) data collection done and toothbrushes were distributed. Same was done for remaining participant on the remaining days of week. Next week after 7 days, same 15 participants were recalled on the same day for data collection. This was done for every 15 participants of the other 6 groups also. Again after 14 and 21 days data was collected.
Secondary outcome [1] 443454 0
nil
Timepoint [1] 443454 0
nil

Eligibility
Key inclusion criteria
1. Individual having Plaque and Gingival score at least 1
2. Individual having at least 5 teeth (excluding third molar) in each
quadrant with facial and lingual scorable surfaces
Minimum age
18 Years
Maximum age
27 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Individual with systemic illness
2. Individual with orthodontic appliances
3. Individual requiring any emergency dental treatment
4. Individual not willing to participate in the study
5. Individual with advanced periodontal disease
6. Individual with a history of antibiotic usage or using antibiotic
7. Individual taking any oral prophylactic agents.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
An assistant, not participating in the study prepared sequentially numbered, opaque, sealed envelopes and participants picked the envelope according to the sequence. Based on assigned group, respective treatment was carried out as described in the procedure.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The total of 105 students eligible for study were selected. Subjects were assigned in a ratio of 1:1:1 in three groups based on computer generated random numbers and each student was assigned to a group A, B and C for Oral B Shiny Clean Toothbrush, Oral B Pro Health and Oral B Sensitive Care, respectively
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive analysis:
Mean, Standard Deviation, Median, Range and Proportion were calculated for baseline characteristics of participants and presented in tabulated form.
Inferential analysis:
Friedman’s test was used to assess the association of plaque and gingival scores in different follow up. For Pairwise PI and GI score differences between follow up data collection were assessed from Wilcoxon Signed Rank test and intergroup comparison of plaque and gingival scores were calculated from Kruskal Wallis test. One way ANOVA and Chi-square test were used to see the association of demographic variables between the three groups at baseline.
#About the sample size
Sample size was calculated by taking pooled standard deviation (0.07271),mean difference between gingival indices of both Crisscross and Flat toothbrush was 0.1717 were taken from study done by Narang et al.
Considering 95% of confidence interval, 80% of the power of the study and taking 1:1:1 sample ratio unit, these values were put into software nMaster 2.0 to calculate sample size. The sample size determined was 31.Considering 10% attrition rate, the total sample size became 35 in each group.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
8/04/2021
Date of last participant enrolment
Anticipated
Actual
8/04/2021
Date of last data collection
Anticipated
Actual
28/04/2021
Sample size
Target
105
Accrual to date
Final
105
Recruitment outside Australia
Country [1] 26804 0
Nepal
State/province [1] 26804 0
BPKIHS, Dharan

Funding & Sponsors
Funding source category [1] 318084 0
Self funded/Unfunded
Name [1] 318084 0
Country [1] 318084 0
Primary sponsor type
Individual
Name
principal author [ Dr. Ratna Mishal], Madan Bhandari hospital and trauma center, Urlabari
Address
Country
Nepal
Secondary sponsor category [1] 320440 0
None
Name [1] 320440 0
none
Address [1] 320440 0
Country [1] 320440 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316731 0
Institutional Review Committee (IRC), B.P. Koirala Institute of Health Sciences, Dharan Nepal (Ref. No. 278/077/078-IRC) obtained Code no. of IRC/1864/020
Ethics committee address [1] 316731 0
BPKIHS,Dharan-18, Ghopa Camp, Sunsari , Koshi province, Nepal postcode: 56700
Ethics committee country [1] 316731 0
Nepal
Date submitted for ethics approval [1] 316731 0
12/11/2020
Approval date [1] 316731 0
15/12/2020
Ethics approval number [1] 316731 0
Ethics committee name [2] 316732 0
Nepal Health Research Council (NHRC), Ram Shah Path Kathmandu, Ethical Review Board Protocol No. 813/2020 MT
Ethics committee address [2] 316732 0
NHRC, Ramshah Path, Kathmandu, Bagmati province, postcode : 44600,PO Box No 7626
Ethics committee country [2] 316732 0
Nepal
Date submitted for ethics approval [2] 316732 0
17/12/2020
Approval date [2] 316732 0
10/02/2021
Ethics approval number [2] 316732 0

Summary
Brief summary
The purpose of the study was to compare the effectiveness of plaque control and reduction in gingival inflammation of three different toothbrush bristle design.
Hypothesis: Advanced bristle designed toothbrushes (Crisscross and Zigzag) are effective in plaque control and gingival inflammation than that of conventional (Flat) bristle designed toothbrush.
Trial website
Trial related presentations / publications
Public notes
The study was approved from Institutional Review Committee (IRC), B.P. Koirala Institute of Health Sciences, Dharan Nepal (Ref. No. 278/077/078-IRC) and from Nepal Health Research Council (NHRC), Ram Shah Path Kathmandu (Ref. No. 2239) and obtained Ethical Review Board Protocol No. 813/2020 MT.
The study was registered as a clinical trial by (npctr.nhrc.gov.np) Nepal
clinical Trial Registry (Ref no. 2021/04/000069) and the Trial No. is NPCTR2021000616.

Contacts
Principal investigator
Name 138826 0
Dr Ratna Mishal
Address 138826 0
Madan Bhandari Hospital and Trauma Center, Urlabari. postal code: 56604, province-1, Damak-5 ,Jhapa
Country 138826 0
Nepal
Phone 138826 0
+9779863804206
Fax 138826 0
Email 138826 0
[email protected]
Contact person for public queries
Name 138827 0
Ratna Mishal
Address 138827 0
Madan Bhandari Hospital and Trauma Center, Urlabari. postal code: 56604, province-1, Damak-5, Jhapa
Country 138827 0
Nepal
Phone 138827 0
+9779863804206
Fax 138827 0
Email 138827 0
[email protected]
Contact person for scientific queries
Name 138828 0
Ratna Mishal
Address 138828 0
Madan Bhandari Hospital and Trauma Center, Urlabari. postal code: 56604, province-1,Damak-5, Jhapa
Country 138828 0
Nepal
Phone 138828 0
+9779863804206
Fax 138828 0
Email 138828 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24475Othernone   Abstract 388942-(Uploaded-02-02-2025-20-29-12)-Abstract.docx



Results publications and other study-related documents

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