CTRI Number |
CTRI/2020/04/024652 [Registered on: 15/04/2020] Trial Registered Prospectively |
Last Modified On: |
21/08/2024 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Dentistry |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
Comparison between Cleaning Efficiency of Natural toothbrush and Artificial toothbrush in Children of 8-10 Years of Age |
Scientific Title of Study
|
Comparing Plaque Removal Efficacy of Biodegradable Toothbrush and Non-Biodegradable Toothbrush in Children of 8-10 Years of Age: A Randomized Clinical Double Blinded Study |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr AROHI DESAI |
Designation |
Post graduate student |
Affiliation |
K M Shah Dental College and Hospital Sumandeep Vidyapeeth |
Address |
Dept of Pediatric and Preventive Dentistry K M Shah Dental College and Hospital Sumandeep Vidyapeeth Deemed To Be University Campus At Post Piparia Tal Waghodia Vadodara Gujarat
Vadodara GUJARAT 391760 India |
Phone |
7768982731 |
Fax |
|
Email |
drarohi23@yahoo.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Pratik Kariya |
Designation |
Reader |
Affiliation |
K M Shah Dental College and Hospital Sumandeep Vidyapeeth |
Address |
Dept of Pediatric and Preventive Dentistry K M Shah Dental College and Hospital Sumandeep Vidyapeeth Deemed To Be University Campus At Post Piparia Tal Waghodia Vadodara Gujarat
Vadodara GUJARAT 391760 India |
Phone |
9558330199 |
Fax |
|
Email |
prateek.kariya@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Pratik Kariya |
Designation |
Reader |
Affiliation |
K M Shah Dental College and Hospital Sumandeep Vidyapeeth |
Address |
Dept of Pediatric and Preventive Dentistry K M Shah Dental College and Hospital Sumandeep Vidyapeeth Deemed To Be University Campus At Post Piparia Tal Waghodia Vadodara Gujarat
Vadodara GUJARAT 391760 India |
Phone |
9558330199 |
Fax |
|
Email |
prateek.kariya@gmail.com |
|
Source of Monetary or Material Support
|
Dept of Pediatric and Preventive Dentistry K M Shah Dental College and Hospital Sumandeep Vidyapeeth Deemed To Be University Campus At Post Piparia Tal Waghodia Vadodara Gujarat |
|
Primary Sponsor
|
Name |
Dr Arohi Desai |
Address |
Dept of Pediatric and Preventive Dentistry K M Shah Dental College and Hospital Sumandeep Vidyapeeth Deemed To Be University Campus At Post Piparia Tal Waghodia Vadodara Gujarat |
Type of Sponsor |
Other [Self Funded ] |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 3 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Arohi Desai |
Bal Gokulam Children Home |
1, Arya Kanya Road, Karelibaug
390001 Vadodara GUJARAT |
7768982731
drarohi23@yahoo.com |
Dr Arohi Desai |
C H Vidyalaya |
Gotri Road, Behind TB hospital, Chanadra Nagar, Gotri
390015 Vadodara GUJARAT |
7768982731
drarohi23@yahoo.com |
Dr Arohi Desai |
Nutan Vidyalaya |
Ward No, 10, High tension Road, Subhanpura
390023 Vadodara GUJARAT |
7768982731
drarohi23@yahoo.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Sumandeep Vidyapeeth Institutional Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
healthy oral hygiene |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Bamboo toothbrush |
Handle made up of bamboo and bristles made up of corn fiber and nylon 4. |
Intervention |
Bamboo toothbrush |
Handle made up of Indian bamboo and bristles made are bisphenol A free. |
Comparator Agent |
Plastic toothbrush |
Handle and bristles made up of plastic and nylon 6. |
|
Inclusion Criteria
|
Age From |
8.00 Year(s) |
Age To |
10.00 Year(s) |
Gender |
Both |
Details |
Children with a Plaque score of more than or equal to 1.75 according to Turesky modification of the Quigley–Hein index (TQHI) plaque index. |
|
ExclusionCriteria |
Details |
Children who were regularly on antibiotics or other drugs.
Children with any oral soft tissue lesions.
Children with crowded teeth.
Children with more than 3 carious lesions at the time of screening.
Children with special health care needs.
Children with gingival or periodontal inflammation.
Children with pre-shedding mobility.
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Investigator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Plaque removal efficacy |
Plaque removal efficacy on 1st, 3rd and 7th day. |
|
Secondary Outcome
|
Outcome |
TimePoints |
Bamboo toothbrush is equally effective in plaque removal. |
Plaque removal efficacy on 1st, 3rd and 7th day. |
|
Target Sample Size
|
Total Sample Size="90" Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "86"
Final Enrollment numbers achieved (India)="86" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
15/06/2020 |
Date of Study Completion (India) |
23/10/2021 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
23/10/2021 |
Estimated Duration of Trial
|
Years="1" Months="3" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Kariya PB, Desai A, Singh S, Bansal B, Shah Y. Comparing plaque removal efficacy of biodegradable toothbrush and nonbiodegradable toothbrush in children of 8-10 years of age: A randomized clinical study. J Indian Soc Pedod Prev Dent. 2024 Apr 1;42(2):112-118. doi: 10.4103/jisppd.jisppd_61_24. Epub 2024 Jun 28. PMID: 38957908. |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Oral cavity is considered as the mirror of body; thus, maintenance of good oral hygiene is important so as to have healthy body. Good oral hygiene is achieved by effective plaque removal using a toothbrush, along with correct brushing technique and duration of brushing. Manual toothbrush is the most widely used cleaning aid, as it is easily available and economical. As every coin has two sides, manual toothbrushes also have disadvantage of being made of plastic which is not recyclable and stays on land and ocean till many years, electric toothbrushes have rechargeable battery which leaks and causes land pollution. Hence, we should return back to using natural or biodegradable toothbrush. We can use recyclable and biodegradable toothbrush instead of conventional brush which is made up of plastic which is not recyclable. On searching the literature till 22nd Oct’19 with the keys words like biodegradable, non-biodegradable toothbrushes on search engines like Pubmed, Medline and Google Scholar gave very scanty results, thus the need of the study to compare plaque removal efficacy of biodegradable and non-biodegradable toothbrushes in 8-10 years old children arises. It is hypothesised that there is no difference in plaque removal efficacy between biodegradable (Bamboo India kids toothbrush and PaletteTM India) and non-biodegradable toothbrushes in 8-10 years old children. The aim of the study was to evaluate and compare plaque removal efficacy of biodegradable toothbrush and non-biodegradable toothbrush in children of 8-10 years of age. To evaluate plaque removal efficacy of biodegradable toothbrushes (Bamboo India kids toothbrush and PaletteTM India) and non-biodegradable toothbrush (Colgate kids toothbrush with soft bristles) on day 0, 3 and 7 using the Turesky modification of the Quigley Hein Index and to compare plaque removing efficacy of both biodegradable and non-biodegradable toothbrushes. After receiving an approval from the SVIEC (SVIEC/ON/DENT/BNPG-18/D19050) and respective school authority the study was started. From schools in Vadodara, 3 schools were contacted from different areas of the city. Subsequently, oral screening under natural light was done using sterilised instruments by principal investigator for the children of 8-10 years old. After screening, plaque disclosing agent (DPI Alphaplac, DPI Benefit India PVT. LTD.) was applied to record the baseline plaque score using a swab and Turesky modification of Quigley Hein index was used. Children with a plaque score of ≥1.75, meeting other inclusion criteria and whose parents / guardian were give written informed consent, were included in the study. All the information related to the study was given to them prior to start of study. All the participating children and the care taker / teacher were together given demonstration of tooth brushing (Modified Bass Technique) with the help of a brushing model by the principal investigator. The care taker will be calibrated to supervise brushing. Children were provided with a chart in which care taker / teacher will mark in a box after every brushing. The children were then taken to common brushing area and were asked to brush for two minutes using Modified Bass Technique under supervision of care taker and co-investigator. The participants were instructed to brush their teeth twice daily using given toothbrushes during the study period. Toothpaste (Colgate Strong Teeth Toothpaste, Colgate- Pamolive India Limited) was also provided by the principal Investigator along with the toothbrush to reduce the bias. They were asked to refrain from all oral hygiene procedures for 12 hours prior to each measurement appointment. During the study period, use of mouth rinses, gels or chewing gums were prohibited. Plaque score were recorded again after brushing, following the application of disclosing agent by principal investigator. Plaque score was evaluated three times during the study, firstly before the start of study to check for inclusion criteria (baseline score on Day 1), then on the first visit (Day 7) after supervised brushing and lastly on 14th day after brushing. Photographs of the clinical intraoral examination and the procedure of recording index in the children were taken for record purpose. The Principal investigator visited the school on Day 7 and reinforced the technique of brushing to children given on day 1 and after that plaque score were recorded by the principal investigator following the same regimen. On day 14 the same procedure which was carried out on day 7 and 14 was carried out and final plaque score were recorded. TQHI scores were recorded from the buccal and lingual surfaces of all gradable teeth, and the average scores were calculated for each subject. Plaque score at day 1 showed that Biodegradable toothbrush, Palette TM had highest score of 3.56 and Non-biodegradable toothbrush, Colgate lowest score of 3.31 which was not statistically significant. Plaque score at day 7 showed that group C had highest value of 3.43 and Biodegradable toothbrush, Bamboo India has the least value of 3.3 which was not statistically significant. Plaque score at Day 14 shows that Biodegradable toothbrush, Palette TM has the highest value of 3.29 and Biodegradable toothbrush, Bamboo India has the least value of 2.75. When comparing the mean values of Plaque score of Biodegradable toothbrush, Bamboo India at Day 7 and Plaque score at Day 14, the mean values of Plaque score at Day 7 is higher with a difference of 0.50 which is statistically significant with a p value of <0.001. According to results, it can be concluded that biodegradable toothbrush has adequate plaque removal efficacy and reduces plaque score in comparison to non-biodegradable toothbrush. Therefore, use of biodegradable toothbrush can be recommended which will reduce plastic waste. |