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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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