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

randomized controlled trail

Registration number: NPCTR2021000016
Register By : Ratna Mishal
Registered Date : 2021/05/05
Email : ratnamishal53@gmail.com
Titles & IDs
Refrence Number : REF/2021/05/000069
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
Trial Acronyms : randomized controlled trail
Registration Type : Prospective
Secondary Id : ratnamishal53@gmail.com
Recruitment Country : Nepal

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 (Trail coordinator for multi centric study)

Principal Investigator ( 1 )

Name
Ratna Mishal
Email
ratnamishal18@gmail.com
Contact No
9863804206
Designation
junior resident
Orgnizational Affilation
B.P. Koirala Institute Of Health Science
Address
Dharan, Nepal
Country
Nepal

Contact person (scientific query)
Name
Ratna Mishal
Email
ratnamishal18@gmail.com
Contact No
9863804206
Designation
junior resident
Orgnizational Affilation
B.P. Koirala Institute Of Health Science
Address
Dharan, Nepal
Country
Nepal

Contact person (Public Query)
Name
Ratna Mishal
Email
ratnamishal18@gmail.com
Contact No
9863804206
Designation
junior resident
Orgnizational Affilation
B.P. Koirala Institute Of Health Science
Address
Dharan, Nepal
Country
Nepal

Contact person (Public Query)
Name
Ratna Mishal
Email
ratnamishal18@gmail.com
Contact No
9863804206
Designation
junior resident
Orgnizational Affilation
B.P. Koirala Institute Of Health Science
Address
Dharan, Nepal
Country
Nepal

Sponsor
Type
Others (Please specify)
Name
Ratna Mishal
Email
ratnamishal53@gmail.com
Contact
9821122882
Address
B.P koirala institute of Health Sciences

Recruitment Country
Country
Nepal

Site(s) of study
Site Address
Ramhah Path, Kathmandu
Contact Person Name
Nepal Health Research Council
Contact Person Email
nhrc@nh rc.gov. np
Contact Person Contact
014254220

Ethics Committees Informations
Ethics Committee
Nepal Health Research Council
Ethics Committee Contact
014254220
Ethics Committee Address
Ramhah Path, Kathmandu
Ethics Committee Email
nhrc@nhrc.gov.np

Approvals
Status
Approved
Date
2021-02-12

Health condition(s)
Status
Healthy human volunteers

Study type
Thesis
Yes
Type of trial
Interventional
Study Type
Preventive, Preventive,

Study Design
Allocation
randomized controlled trial
Masking
blinded (masking used)
Control
active
Assignment
parallel
purpose
prevention
Trial Phase
N/A

Intervention and comparison
Intervention name
criss-cross and zig-zag bristle designed toothbrush
Intervention details
  • a.Oral B pro health (criss-cross)-soft
  • b.Oral B shiny clean toothbrush (zig-zag)-soft
Comparison name
flat bristle designed toothbrush
Comparison details
  • a.Oral B sensitive care toothbrush( flat)-soft

Eligibility (Inclusion criteria)
Age Group
20 years - 25 years
Gender
Female
Detail

  • Individual having GI and PI score atleast 1
  • At least 5 teeth (excluding third molar) in each quardant with facial and lingual scorable surfaces
Exclusion Detail
  • 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.
Sample Size
Considering 95% confidence interval, 80% power of study and mean score of gingival index of both criss-cross and flat toothbrush taking from study done by Narang et al.18 Putting above values in following formula, n = 2σ2(z1-α+z1-β)2
Enrollment Date
2021-02-01
Completion Date
2021-03-31
Enrollment Status

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