| CTRI Number |
CTRI/2025/07/091659 [Registered on: 24/07/2025] Trial Registered Prospectively |
| Last Modified On: |
23/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Bamboo vs. Plastic Toothbrushes in adults |
|
Scientific Title of Study
|
ASSESSING THE EFFECTIVENESS OF
BAMBOO AND PLASTIC
TOOTHBRUSHES IN ENHANCING
PLAQUE CONTROL AND GINGIVAL
HEALTH: A RANDOMIZED
CONTROLLED TRIAL |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aruhi Sinha |
| Designation |
Post graduate student |
| Affiliation |
Government Dental College & Hospital Raipur, Chhattisgarh |
| Address |
Department of Public Health Dentistry, Government Dental College Raipur, Chhattisgarh, India, 492001
Department of Public Health Dentistry, Government Dental College Raipur, Chhattisgarh, India, 492001
Raipur
CHHATTISGARH
492001
India |
| Phone |
7033688832 |
| Fax |
0771-2222990 |
| Email |
aruhi.sinha1708@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ramakrishna Chevvuri |
| Designation |
Associate Professor |
| Affiliation |
Government Dental College & Hospital Raipur, Chhattisgarh |
| Address |
Department of Public Health Dentistry, Government Dental College Raipur, Chhattisgarh, India, 492001
Department of Public Health Dentistry, Government Dental College Raipur, Chhattisgarh, India, 492001
Raipur
CHHATTISGARH
492001
India |
| Phone |
9826177279 |
| Fax |
0771-2222990 |
| Email |
drrkc15@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aruhi Sinha |
| Designation |
Post graduate student |
| Affiliation |
Government Dental College & Hospital Raipur, Chhattisgarh |
| Address |
Department of Public Health Dentistry, Government Dental College Raipur, Chhattisgarh, India, 492001
Department of Public Health Dentistry, Government Dental College Raipur, Chhattisgarh, India, 492001
Raipur
CHHATTISGARH
492001
India |
| Phone |
7033688832 |
| Fax |
0771-2222990 |
| Email |
aruhi.sinha1708@gmail.com |
|
|
Source of Monetary or Material Support
|
| Primary Investigator, Department of Public Health Dentistry, Government Dental College Raipur, Chhattisgarh, India, 492001 |
|
|
Primary Sponsor
|
| Name |
Dr. Aruhi Sinha |
| Address |
Government Dental College, Raipur, Chhattisgarh |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Aruhi Sinha |
Government Dental College |
room No. 13,Department of Public Health Dentistry, Government Dental College Raipur, Chhattisgarh, India, 492001
Raipur
CHHATTISGARH |
9470652267
aruhi.sinha1708@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Dental College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
U00-U85 |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bamboo Toothbrush |
A manual toothbrush made of bamboo with soft nylon bristles, used twice daily for toothbrushing as per standard oral hygiene recommendations. |
| Comparator Agent |
Plastic Toothbrush |
A manual toothbrush made of plastic with soft nylon bristles, used twice daily for toothbrushing as per standard oral hygiene recommendations. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
44.00 Year(s) |
| Gender |
Both |
| Details |
Individuals aged between 18 and 44 years who have at least 20 natural teeth will be included in the study. Participants must be willing to provide informed consent and demonstrate a commitment to complying with the study protocol. They should also agree to follow the prescribed oral hygiene instructions and attend all scheduled follow-up visits as required. |
|
| ExclusionCriteria |
| Details |
Individuals with systemic conditions that may affect oral health, those taking medications known to influence oral health or microbial flora such as antibiotics or corticosteroids, those undergoing orthodontic treatment or using oral appliances will be excluded from the study. Pregnant or lactating women and individuals with active periodontal disease requiring treatment beyond routine oral prophylaxis will also not be eligible to participate. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Plaque Index Score (Silness and Löe Index) – Mean reduction in plaque accumulation from baseline to 2 weeks and 4 weeks.
Gingival Index Score (Löe and Silness Index) – Mean reduction in gingival inflammation from baseline to 2 weeks and 4 weeks. |
Plaque Index Score (Silness and Löe Index) – Mean reduction in plaque accumulation from baseline to 2 weeks and 4 weeks.
Gingival Index Score (Löe and Silness Index) – Mean reduction in gingival inflammation from baseline to 2 weeks and 4 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Toothbrush Wear Assessment – Evaluation of bristle wear and deformation using a standardized wear index at 4 weeks.
Microbial Analysis – Quantitative assessment of oral microbial load (e.g., Streptococcus mutans and Lactobacillus spp.) using saliva samples at baseline, 2 weeks, 4 weeks. |
2 and 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="88"
Sample Size from India="88"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [aruhi.sinha1708@gmail.com].
- For how long will this data be available start date provided 16-03-2025 and end date provided 16-03-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Oral health is crucial for overall well-being, impacting functions like eating, speaking, and social interactions. Poor
oral health is linked to systemic diseases such as cardiovascular disease, diabetes, and respiratory illnesses.
Toothbrushes play a vital role in oral hygiene, but plastic toothbrushes contribute significantly to environmental
pollution. With an estimated 400 million toothbrushes discarded annually in the United States alone, plastic waste
poses a major ecological concern due to its non-biodegradable nature. Bamboo toothbrushes have emerged as an
eco-friendly alternative, offering biodegradable handles and comparable effectiveness in plaque removal and
gingival health.
This randomized controlled trial (RCT) aims to compare bamboo and plastic toothbrushes in terms of plaque removal,
gingival health improvement, and microbial contamination. The study will recruit 88 healthy adults (aged 18–44
years) from the Outpatient Department (OPD) of Government Dental College and Hospital, Raipur, Chhattisgarh.
Participants will be randomly assigned to Group A (bamboo toothbrush) or Group B (plastic toothbrush).
The study objectives include evaluating plaque removal using plaque indices, assessing gingival health through
gingival indices, and analyzing microbial contamination post-use. Ethical approval will be obtained, and informed
consent will be taken from participants.
Previous studies indicate that bamboo toothbrushes may initially harbor more bacteria but show a significant
reduction over time. This study will contribute valuable evidence on their effectiveness and hygienic conditions,
guiding recommendations for sustainable oral hygiene practices. |