Children, AdultNCT06541743
Efficacy of Regular, Musical and Electric Toothbrushes in Plaque Removal in Children
A study testing Regular Toothbrush, Musical toothbrush and Electric toothbrush in people with Children, Adult and Plaque, run by Jouf University at 1 site in Saudi Arabia.
Trial summary
Tooth brushing is essential for maintaining oral hygiene, especially in children, who are at a critical stage for developing lifelong oral health habits. Establishing effective tooth brushing behaviors for school-aged children (6-12 years) is vital for long-term dental health. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Children, Adult, Plaque
- What is being tested?
- Regular Toothbrush, Musical toothbrush and Electric toothbrush
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Jan 2024to 1 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 6-12 years;
- Cooperative children; and
- Children with a minimum of twenty teeth
Who cannot join
- Children with poor oral hygiene characterized by extrinsic stains or calculus deposits;
- Presence of any oral lesions;
- Presence of malocclusion; and
- Medically compromised patients
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
College of Dentistry, Jouf University
Sakakah, Al Jawf Region, 75432
About this study
Official title: Efficacy of Regular, Musical and Electric Toothbrushes in Plaque Removal in Children - A Randomized Clinical Trial
Tooth brushing is essential for maintaining oral hygiene, especially in children, who are at a critical stage for developing lifelong oral health habits. Establishing effective tooth brushing behaviors for school-aged children (6-12 years) is vital for long-term dental health. Consistent and effective tooth brushing is crucial for reducing supragingival plaque, which is key to preventing periodontal diseases and ensuring good oral hygiene. Despite the availability of various plaque control methods, tooth brushing remains the most effective and safest approach.
However, young children, particularly those under ten, often struggle with the dexterity and motivation needed for proper tooth brushing, resulting in inadequate plaque removal. Manual tooth brushing, though effective, can become monotonous and fail to engage children, making it difficult to establish regular brushing habits. Studies have shown that regular removal of supragingival plaque can significantly reduce both supra- and subgingival pathogenic species, underscoring the importance of effective plaque control.
Innovative solutions such as electric and musical toothbrushes have been developed to address these challenges.
Read the detailed description
Electric toothbrushes enhance plaque removal through mechanical action, while musical toothbrushes aim to boost motivation and compliance by incorporating interactive elements like music and colorful designs. Musical toothbrushes play music for two minutes, encouraging children to brush for the recommended duration and making the activity more enjoyable. Previous research has shown varying levels of success with these advanced toothbrushes. For example, one of the recent study have found that musical toothbrushes significantly improved plaque control compared to regular ones. Similarly, other studies have reported substantial plaque reduction with musical toothbrushes. Furthermore, it has been observed that while both manual and powered toothbrushes improved clinical parameters, powered toothbrushes had a more significant impact on gingival health.
Despite these promising results, there is a lack of comprehensive comparative studies on the efficacy of regular, electric, and musical toothbrushes in children. This study aimed to address this gap by conducting a randomized clinical trial to evaluate and compare the effectiveness of these three types of toothbrushes in removing supragingival plaque in children aged 6-12 years.
To the best of our knowledge, this is the first clinical study wherein the comparisons had been made between regular, musical and electric toothbrushes. The findings will provide valuable insights into the most effective tools for promoting oral hygiene in children, potentially shaping future recommendations and practices in pediatric dentistry.
- Conditions
- Children, Adult, Plaque
- Being tested
- Regular Toothbrush, Musical toothbrush, Electric toothbrush
- Keywords
- Children, Oral Health, Toothbrush, Plaque Removal
- Medical subject headings
- Plaque, Amyloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regular ToothbrushDevice
Participants and their guardians will be instructed in the horizontal scrub technique and asked to adhere to a brushing regimen of two minutes, twice daily, for 45 days. Standard fluoride toothpaste and a diary for recording brushing experiences will also provided. Guardians will be supervised brushing to ensure compliance and prevent the use of other oral hygiene measures.
Musical toothbrushDevice
Participants and their guardians will be instructed in the horizontal scrub technique and asked to adhere to a brushing regimen of two minutes, twice daily, for 45 days. Standard fluoride toothpaste and a diary for recording brushing experiences will also provided. Guardians will be supervised brushing to ensure compliance and prevent the use of other oral hygiene measures.
Electric toothbrushDevice
Participants and their guardians will be instructed in the horizontal scrub technique and asked to adhere to a brushing regimen of two minutes, twice daily, for 45 days. Standard fluoride toothpaste and a diary for recording brushing experiences will also provided. Guardians will be supervised brushing to ensure compliance and prevent the use of other oral hygiene measures.
| Study group | Role | What they receive |
|---|---|---|
| Regular Toothbrush | Active comparator | Oral-B Chhota Bheem Toothbrush. Receives: Device: Regular Toothbrush |
| Musical Toothbrush | Active comparator | Aqua White Musical Chhota Bheem Toothbrush. Receives: Device: Musical toothbrush |
| Electric Toothbrush | Active comparator | Oral-B Star Wars Kids Electric Toothbrush. Receives: Device: Electric toothbrush |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque Index (Quigley and Hein)
Plaque assessments was conducted at baseline (day 0) and on days 15, 30, and 45. Participants were refrain from oral hygiene for 24 hours before each recall visit. During each visit, they were supposed to brush under supervision for two minutes with their assigned toothbrush and toothpaste. Plaque disclosure was achieved using a 5 mL disclosing solution for 15 seconds, followed by rinsing with 10 mL water for 10 seconds.
Quigley-Hain plaque index
0
No plaque
1
Isolated flecks of plaque at the gingival margin
2
A continuous band of plaque up to 1mm at the gingival margin
3
Plaque greater than 1mm in width and covering up to one third of the tooth surface
4
Plaque covering from one thirds to two thirds of the tooth surface
5
Plaque covering more than two thirds of the tooth surface
Measured: 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start1 Jan 2024
- Primary completion1 Mar 2024
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Children, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- * (Regular Toothbrush): Oral-B Chhota Bheem Toothbrush. * (Musical Toothbrush): Aqua White Musical Chhota Bheem Toothbrush. * (Electric Toothbrush): Oral-B Star Wars Kids Electric Toothbrush
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jouf University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rakhi Issrani, Jouf University
- Investigators
- Namdeo Prabhu, MDS, Study chair, College of Dentistry, Jouf University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06541743
- Sponsor's protocol ID
- (DGSSR-2023-01-02524)
- Status last verified
- Aug 2024
- First submitted
- 17 Jul 2024
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kitsaras G, Goodwin M, Kelly MP, Pretty IA. Bedtime Oral Hygiene Behaviours, Dietary Habits and Children's Dental Health. Children (Basel). 2021 May 19;8(5):416. doi: 10.3390/children8050416.
PubMed 34069504Axe A, Mueller WD, Rafferty H, Lang T, Gaengler P. Impact of manual toothbrush design on plaque removal efficacy. BMC Oral Health. 2023 Oct 25;23(1):796. doi: 10.1186/s12903-023-03518-6.
PubMed 37880662Feres M, Gursky LC, Faveri M, Tsuzuki CO, Figueiredo LC. Clinical and microbiological benefits of strict supragingival plaque control as part of the active phase of periodontal therapy. J Clin Periodontol. 2009 Oct;36(10):857-67. doi: 10.1111/j.1600-051X.2009.01471.x. Epub 2009 Aug 23.
PubMed 19703236Mateu FA, Boneta AE, DeVizio W, Stewart B, Proskin HM. A clinical investigation of the efficacy of two dentifrices for controlling established supragingival plaque and gingivitis. J Clin Dent. 2008;19(3):85-94.
PubMed 193015145. Liu L. The impact of innovation of electric toothbrush. 2022. https://doi.org/10.2991/aebmr.k.220307.295
Prendergast V, Chapple KM. Evaluation and Acceptance of an Electric Toothbrush Designed for Dependent Patients. Cureus. 2021 Jun 1;13(6):e15372. doi: 10.7759/cureus.15372. eCollection 2021 Jun.
PubMed 34249525Lee J, Park HM, Kim YW. Comparative Analysis of Plaque Removal and Wear between Electric-Mechanical and Bioelectric Toothbrushes. Bioengineering (Basel). 2024 May 9;11(5):474. doi: 10.3390/bioengineering11050474.
PubMed 38790341Vargas CM, Arevalo O. How dental care can preserve and improve oral health. Dent Clin North Am. 2009 Jul;53(3):399-420. doi: 10.1016/j.cden.2009.03.011.
PubMed 19482119Ganesh M, Shah S, Parikh D, Choudhary P, Bhaskar V. The effectiveness of a musical toothbrush for dental plaque removal: a comparative study. J Indian Soc Pedod Prev Dent. 2012 Apr-Jun;30(2):139-45. doi: 10.4103/0970-4388.99988.
PubMed 2291809910. Pillay R, Mathur A, Jain M, Singh A, Gupta V. Comparative efficacy of musical and regular toothbrush in children. Int J Curr Res Rev. 2021;13(14):142-7.
Subburaman N, Madan Kumar PD, Iyer K. Effectiveness of musical toothbrush on oral debris and gingival bleeding among 6-10-year-old children: A randomized controlled trial. Indian J Dent Res. 2019 Mar-Apr;30(2):196-199. doi: 10.4103/ijdr.IJDR_128_17.
PubMed 31169149Haffajee AD, Thompson M, Torresyap G, Guerrero D, Socransky SS. Efficacy of manual and powered toothbrushes (I). Effect on clinical parameters. J Clin Periodontol. 2001 Oct;28(10):937-46. doi: 10.1034/j.1600-051x.2001.028010937.x.
PubMed 11686812
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Regular, Musical and Electric Toothbrushes in Plaque Removal in Children - A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06541743
- Acronym / sponsor ID
- (DGSSR-2023-01-02524)
- Conditions
- Children, Adult, Plaque
- Keywords
- Children, Oral Health, Toothbrush, Plaque Removal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Jouf UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 7 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Tooth brushing is essential for maintaining oral hygiene, especially in children, who are at a critical stage for developing lifelong oral health habits. Establishing effective tooth brushing behaviors for school-aged children (6-12 years) is vital for long-term dental health. Consistent and effective tooth brushing is crucial for reducing supragingival plaque, which is key to preventing periodontal diseases and ensuring good oral hygiene. Despite the availability of various plaque control methods, tooth brushing remains the most effective and safest approach.
However, young children, particularly those under ten, often struggle with the dexterity and motivation needed for proper tooth brushing, resulting in inadequate plaque removal. Manual tooth brushing, though effective, can become monotonous and fail to engage children, making it difficult to establish regular brushing habits. Studies have shown that regular removal of supragingival plaque can significantly reduce both supra- and subgingival pathogenic species, underscoring the importance of effective plaque control.
Innovative solutions such as electric and musical toothbrushes have been developed to address these challenges.
Detailed description
Electric toothbrushes enhance plaque removal through mechanical action, while musical toothbrushes aim to boost motivation and compliance by incorporating interactive elements like music and colorful designs. Musical toothbrushes play music for two minutes, encouraging children to brush for the recommended duration and making the activity more enjoyable. Previous research has shown varying levels of success with these advanced toothbrushes. For example, one of the recent study have found that musical toothbrushes significantly improved plaque control compared to regular ones. Similarly, other studies have reported substantial plaque reduction with musical toothbrushes. Furthermore, it has been observed that while both manual and powered toothbrushes improved clinical parameters, powered toothbrushes had a more significant impact on gingival health.
Despite these promising results, there is a lack of comprehensive comparative studies on the efficacy of regular, electric, and musical toothbrushes in children. This study aimed to address this gap by conducting a randomized clinical trial to evaluate and compare the effectiveness of these three types of toothbrushes in removing supragingival plaque in children aged 6-12 years.
To the best of our knowledge, this is the first clinical study wherein the comparisons had been made between regular, musical and electric toothbrushes. The findings will provide valuable insights into the most effective tools for promoting oral hygiene in children, potentially shaping future recommendations and practices in pediatric dentistry.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- * (Regular Toothbrush): Oral-B Chhota Bheem Toothbrush. * (Musical Toothbrush): Aqua White Musical Chhota Bheem Toothbrush. * (Electric Toothbrush): Oral-B Star Wars Kids Electric Toothbrush
| Arm | Type | Receives |
|---|---|---|
| Regular Toothbrush | Active comparator | Device: Regular ToothbrushOral-B Chhota Bheem Toothbrush. |
| Musical Toothbrush | Active comparator | Device: Musical toothbrushAqua White Musical Chhota Bheem Toothbrush. |
| Electric Toothbrush | Active comparator | Device: Electric toothbrushOral-B Star Wars Kids Electric Toothbrush. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children aged 6-12 years;
- Cooperative children; and
- Children with a minimum of twenty teeth
Key exclusion criteria (4 listed)
- Children with poor oral hygiene characterized by extrinsic stains or calculus deposits;
- Presence of any oral lesions;
- Presence of malocclusion; and
- Medically compromised patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Regular ToothbrushParticipants and their guardians will be instructed in the horizontal scrub technique and asked to adhere to a brushing regimen of two minutes, twice daily, for 45 days. Standard fluoride toothpaste and a diary for recording brushing experiences will also provided. Guardians will be supervised brushing to ensure compliance and prevent the use of other oral hygiene measures. | Device | Regular Toothbrush |
| Musical toothbrushParticipants and their guardians will be instructed in the horizontal scrub technique and asked to adhere to a brushing regimen of two minutes, twice daily, for 45 days. Standard fluoride toothpaste and a diary for recording brushing experiences will also provided. Guardians will be supervised brushing to ensure compliance and prevent the use of other oral hygiene measures. | Device | Musical Toothbrush |
| Electric toothbrushParticipants and their guardians will be instructed in the horizontal scrub technique and asked to adhere to a brushing regimen of two minutes, twice daily, for 45 days. Standard fluoride toothpaste and a diary for recording brushing experiences will also provided. Guardians will be supervised brushing to ensure compliance and prevent the use of other oral hygiene measures. | Device | Electric Toothbrush |
Primary outcome
Plaque Index (Quigley and Hein)
Time frame: 45 days
Plaque assessments was conducted at baseline (day 0) and on days 15, 30, and 45. Participants were refrain from oral hygiene for 24 hours before each recall visit. During each visit, they were supposed to brush under supervision for two minutes with their assigned toothbrush and toothpaste. Plaque disclosure was achieved using a 5 mL disclosing solution for 15 seconds, followed by rinsing with 10 mL water for 10 seconds. Quigley-Hain plaque index 0 No plaque 1 Isolated flecks of plaque at the gingival margin 2 A continuous band of plaque up to 1mm at the gingival margin 3 Plaque greater than 1mm in width and covering up to one third of the tooth surface 4 Plaque covering from one thirds to two thirds of the tooth surface 5 Plaque covering more than two thirds of the tooth surface
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Background: PubMed 34069504Kitsaras G, Goodwin M, Kelly MP, Pretty IA. Bedtime Oral Hygiene Behaviours, Dietary Habits and Children's Dental Health. Children (Basel). 2021 May 19;8(5):416. doi: 10.3390/children8050416.
- Background: PubMed 37880662Axe A, Mueller WD, Rafferty H, Lang T, Gaengler P. Impact of manual toothbrush design on plaque removal efficacy. BMC Oral Health. 2023 Oct 25;23(1):796. doi: 10.1186/s12903-023-03518-6.
- Background: PubMed 19703236Feres M, Gursky LC, Faveri M, Tsuzuki CO, Figueiredo LC. Clinical and microbiological benefits of strict supragingival plaque control as part of the active phase of periodontal therapy. J Clin Periodontol. 2009 Oct;36(10):857-67. doi: 10.1111/j.1600-051X.2009.01471.x. Epub 2009 Aug 23.
- Background: PubMed 19301514Mateu FA, Boneta AE, DeVizio W, Stewart B, Proskin HM. A clinical investigation of the efficacy of two dentifrices for controlling established supragingival plaque and gingivitis. J Clin Dent. 2008;19(3):85-94.
- Background5. Liu L. The impact of innovation of electric toothbrush. 2022. https://doi.org/10.2991/aebmr.k.220307.295
- Background: PubMed 34249525Prendergast V, Chapple KM. Evaluation and Acceptance of an Electric Toothbrush Designed for Dependent Patients. Cureus. 2021 Jun 1;13(6):e15372. doi: 10.7759/cureus.15372. eCollection 2021 Jun.
- Background: PubMed 38790341Lee J, Park HM, Kim YW. Comparative Analysis of Plaque Removal and Wear between Electric-Mechanical and Bioelectric Toothbrushes. Bioengineering (Basel). 2024 May 9;11(5):474. doi: 10.3390/bioengineering11050474.
- Background: PubMed 19482119Vargas CM, Arevalo O. How dental care can preserve and improve oral health. Dent Clin North Am. 2009 Jul;53(3):399-420. doi: 10.1016/j.cden.2009.03.011.
- Background: PubMed 22918099Ganesh M, Shah S, Parikh D, Choudhary P, Bhaskar V. The effectiveness of a musical toothbrush for dental plaque removal: a comparative study. J Indian Soc Pedod Prev Dent. 2012 Apr-Jun;30(2):139-45. doi: 10.4103/0970-4388.99988.
- Background10. Pillay R, Mathur A, Jain M, Singh A, Gupta V. Comparative efficacy of musical and regular toothbrush in children. Int J Curr Res Rev. 2021;13(14):142-7.
- Background: PubMed 31169149Subburaman N, Madan Kumar PD, Iyer K. Effectiveness of musical toothbrush on oral debris and gingival bleeding among 6-10-year-old children: A randomized controlled trial. Indian J Dent Res. 2019 Mar-Apr;30(2):196-199. doi: 10.4103/ijdr.IJDR_128_17.
- Background: PubMed 11686812Haffajee AD, Thompson M, Torresyap G, Guerrero D, Socransky SS. Efficacy of manual and powered toothbrushes (I). Effect on clinical parameters. J Clin Periodontol. 2001 Oct;28(10):937-46. doi: 10.1034/j.1600-051x.2001.028010937.x.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Namdeo Prabhu, MDS study chair
College of Dentistry, Jouf University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regular Toothbrush, Musical toothbrush and Electric toothbrush in people with Children, Adult and Plaque, run by Jouf University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plaque Index (Quigley and Hein) (time frame: 45 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06541743, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2024.