EFFECTIVENESS OF THREE MANUAL TOOTHBRUSHES WITH DIFFERENT BRISTLE DESIGNS IN TERMS OF PLAQUE REMOVAL AND GINGIVAL INFLAMMATION- A RANDOMIZED CONTROLLED TRIAL

1. Study title: Effectiveness of three manual toothbrushes with different bristle designs in terms of plaque removal and gingival inflammation-A Randomized controlled trial

2. Name of the student: Dr. Ratna Mishal

3. Department: Public Health Dentistry

4. Name of Chief guide : Dr. Ashish Shrestha, Professor, Head, Department of Public Health Dentistry

5. Name of Co-guide/s & Department/s:

a. Dr. Tarakant Bhagat, Associate Professor, Department of Public Health Dentistry

b. Dr. Santosh Kumari Agrawal,Assistant Professor ,Department of Public Health Dentistry

6. Email ID of the Candidate & Guide:

ratnamishal18@gmail.com (Candidate)

shrestha.ashish@bpkihs.edu (Chief-guide)

7. Rationale of the research: Brushing method is the most commonly used mechanical method to remove plaque and reduce gingival inflammation .Plaque removal is mainly determined by technique of brushing, time of brushing. Considering these factors as constant, bristle design can also determine the amount of plaque removal. New bristle designs have also been incorporated into manual brushes to better reach proximal and other hard-to-reach areas. There is paucity of published literature which shows effect of bristle designs in removing plaque removal. According to search on internate sites, there is no studies has been conducted in Nepal regarding effectiveness of bristle designs in removing plaque. The result obtained can be used for patient education about bristle designs and further investigation in advanced toothbrushes.

8. Primary objective: To compare the effectiveness of three different designs of manual toothbrushes in plaque control and gingival inflammation among undergraduate girl students.

9. Research Hypothesis/research question:

a) Null hypothesis : All three bristle designed toothbrushes are effective in plaque control and reduction in gingival inflammation.

b) Alternate hypothesis :Advanced bristle designs (crisscross and zigzag) is effective in plaque control and gingival inflammation than that of conventional (flat) bristle designed toothbrush.

10. Materials & Methods:

a) Whether study involves Human/animals or both: Human only

b) Population/ participants: Undergraduate girl students of BPKIHS

c) Type of study design: Randomized controlled parallel study

d) Setting: Undergraduate girls hostel,BPKIHS

e) Sample Selection criteria:

• (i) Inclusion Criteria:
• Individual having GI and PI score atleast 1
• At least 5 teeth (excluding third molar) in each quardant with facial and lingual scorable surfaces

(ii) Exclusion Criteria:

• Individual with systemic illness
• Individual with orthodontic appliances
• Individual requiring any emergency dental treatment
• Individual not willing to participate in the study
• Individual with advanced periodontal disease
• Individual with a history of antibiotic usage or using antibiotic
• Individual taking any oral prophylactic agents.

(iii) Sampling method: Simple random sampling

(iv)Expected sample size: 105 (35 in each group)

f) Control group(s): Groups with flat bristle designed (conventional) toothbrush

g) Probable duration of study: One year

h) Parameter(s)/Variables to be measured:

Dependent variables: plaque control and gingival inflammation

Independent variable: Age and academic year

i) Outcome measures: mean score of plaque index and mean score of gingival index.

j) Statistical methods to be employed: Descriptive Analysis

Mean, Standard Deviation,median,propotion, interquartile Range, will be calculated along with graphical and tabulation presentation will be made.

Inferential Statistics

Paired t-test, wilcoxson sign-rank test , Repeated measures ANOVA, Friedmans test.

k) Ethical clearance: Will be obtained from Institutional Review committee, BPKIHS

i)Permission to use copyright protected questionnaire/ Proforma: not applicable

11. For intervention trial:

A. permission from Drug controller of Nepal: not applicable

B. safety measure: Not applicable

C. Plan to withdraw: Not applicable

12. Maintain the confidentiality of subject: yes

13. References: Attached

14. Whether available resources are adequate: yes

15. Other resources needed: not required

16. Cost involved (Approx. in NRS): 50000

a. stationary: 5,000

b. instruments: 40,000

c. Miscellaneous: 5,000

17. Who will bear the cost of the requirements: : The main examiner will bear the whole cost which will around NRS 50,000 and the cost details is included in the cost involved section of summary.

18. ANNEXURE: Attached

a. Participants record form: Attached

b. Participant Information sheets

i. Attached English

ii. Attached Nepali

c. Participant informed consent forms

i. Attached English

ii. Attached Nepali

d. Abbreviations

Principal Investigator ( 1 )