Wear of electric toothbrush heads in adolescents with fixed orthodontic appliances
| ISRCTN | ISRCTN11860621 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11860621 |
| Secondary identifying numbers | 2013012 |
- Submission date
- 10/11/2022
- Registration date
- 21/12/2022
- Last edited
- 14/02/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Plaque promotes the development of caries, gingivitis and periodontitis. It must be removed regularly and mechanically to prevent this. Patients with fixed orthodontic appliances have an increased risk of caries, as more plaque is accumulated through brackets, arches and other appliance components. These patients often have two to three times more plaque on their teeth than patients without multibracket appliances and a higher risk of white spot lesion development. Due to multibracket appliances increasing the difficulty of achieving a thorough oral hygiene routine, gingivitis is more frequent and usually persists throughout the treatment period. Current research and literature show that there are controversial results on toothbrush wear and its influence on the effectiveness of plaque removal.
The primary objective of this study was to evaluate the degree of wear on electric toothbrush heads used by 12 to 15-year-old subjects with fixed orthodontic appliances over a period of 12 weeks using the wear index. The secondary objective was to examine the development of oral hygiene over time and to clarify to what extent the wear index affects the plaque index.
Who can participate?
Healthy adolescents aged between 12 and 15 years old with generally good oral hygiene and fixed conventional brackets on all eight anterior teeth.
What does the study involve?
At baseline, every test person received the same oral hygiene products. All test persons were instructed to clean their teeth twice a day (morning/evening) for three months for two minutes each, using exclusively the products they received. The study was designed to assess if the participants in the test group experience an improvement in oral health. Plaque index measurements are taken at baseline, and weeks 4, 8 and 12 visits. Subjects are instructed to abstain from any oral hygiene for 12 hours prior to all visits. Only after the plaque index had been collected did the test persons perform their next oral hygiene routine. During the visit, the electric toothbrush head is evaluated and photographed with an assigned number. The papillary bleeding index and the modified plaque index are collected on-site before and after brushing the teeth. If a subject's toothbrush head reaches wear-index grade 4, the study is regarded as finished for the subject at this time for ethical reasons.
What are the possible benefits and risks of participating?
Participation will help with the evaluation of products and their longevity independent of the instructions by the developer to improve oral health in patients with fixed appliances. There are no notable risks involved with participating. This study involves the use of toothbrushes as part of a normal oral hygiene routine. No behaviour with increased risk is requested from participants. The toothpaste provided in this study is currently marketed. The risk from a chemical hazard is negligible, or no greater than what would have been encountered during daily life. Toothbrushes are not anticipated to cause any serious or long-term effects on oral tissue including gum recession.
Where is the study run from?
University Medical Center of the Johannes Gutenberg University (Germany)
When is the study starting and how long is it expected to run for?
August 2013 to June 2014
Who is funding the study?
University Medical Center of the Johannes Gutenberg University (Germany)
Who is the main contact?
Prof. Dr. Christina Erbe, erbe@uni-mainz.de
Contact information
Principal Investigator
Augustusplatz 2
2nd floor, building 901
1.OG Dental clinic
Mainz
55131
Germany
| Phone | +49 (0)6131 17 3024 |
|---|---|
| erbe@uni-mainz.de |
Study information
| Study design | Single-center 12-week 1-treatment study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case series |
| Study setting(s) | Dental clinic, Home |
| Study type | Prevention |
| Participant information sheet | 42747 PIS_Ethikantrag original.pdf |
| Scientific title | A clinical trial to evaluate the wear index of electric toothbrush heads and the correlation of the wear index and the plaque reduction among a population with fixed orthodontic appliances |
| Study objectives | The null hypothesis of this study states that all toothbrush heads remove the same amount of plaque regardless of their wear. The alternative hypothesis states that varying degrees of wear on the toothbrush heads lead to varying degrees of plaque reduction. |
| Ethics approval(s) | Approved, 27/02/2014, The Ethics Committee of the Rhineland-Palatinate Medical Association (Deutschhausplatz 3, 55116 Mainz, Germany; +49 (0)6131 288220; kammer@laek-rlp.de), ref: (9178-F) |
| Health condition(s) or problem(s) studied | Evidence of plaque due to the wear of the toothbrush heads in adolescents with fixed orthodontic appliances |
| Intervention | At baseline, every test person (64 adolescents aged 12-15 years old) received the same oral hygiene products (electric toothbrushes) free of charge. All test persons were instructed to clean their teeth twice a day (morning/evening) for three months for two minutes each, using exclusively the products they received and a prescribed brushing technique. The patients receive a brushing schedule: Before: anamnesis, which takes place before any general dental treatment. During: regular plaque checks After: professional teeth cleaning The test persons returned to the practice after four, eight and twelve weeks with the toothbrush head received at the beginning. The last oral hygiene before a visit was performed on the evening of the previous day. Until the agreed date on the following day, the test persons had to refrain from cleaning their teeth. Only after the plaque index had been collected did the test persons perform their next oral hygiene routine. During the visit, the electric toothbrush head was evaluated and photographed with an assigned number. The papillary bleeding index and the modified plaque index were collected on-site before and after brushing the teeth. If a subject's toothbrush head had reached wear-index grade 4, the study was regarded as finished for the subject at that time for ethical reasons. Wear Index of electric brush heads: The Wear Index is divided into 5 grades that assess the wear of an electric toothbrush brush head. Plaque index based on Silness and Loë (1964): Plaque is assessed without staining on all four tooth surfaces (buccal, lingual, mesial, distal) by eye and probe. Papillary bleeding index (PBI): The PBI assesses local inflammation in the sulcus. PB I= sum of bleeding measuring points: total number of measuring points. With the PBI, it is possible to check whether the patient is practising good oral hygiene on a permanent basis or whether he or she is only practising good dental cleaning before the respective visit to the dentist, while simultaneously recording the plaque index. Screening methods Screening-Baseline Introduction to the clinical trial process Consent by sighing the consent form (by a legal guardian) Dental examination Determination of PI and PBI Independent tooth cleaning by the test subject according to cleaning instructions Oral Hygiene Instructions At Home Only use the electric toothbrush that has been provided Only use the toothpaste that has been provided Only use products according to the instructions twice daily 1st appointment, 4 weeks after baseline Bring the electric toothbrush with the brush head Determination of Wear Index Oral hygiene status (PI, PBI) Independent tooth cleaning of the test person according to brushing instructions Oral hygiene instruction 2nd appointment, 8 weeks after baseline Bring the electric toothbrush with the brush head Determination of Wear Index Oral hygiene status (PI, PBI) Independent tooth cleaning by the test person according to brushing instructions Oral hygiene instruction 3rd appointment, 12 weeks after baseline Bring the electric toothbrush with the brush head Determination of Wear Index Oral hygiene status (PI, PBI) Independent tooth cleaning by the test person according to brushing instructions Oral hygiene instruction Professional tooth cleaning Duration The examinations took place every 4 weeks, up until 12 weeks after baseline. Follow-up activity The patients received a free electric toothbrush. In addition, their oral hygiene was checked and they received instructions accordingly. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | Papillary bleeding after careful dental probing in the papillary region measured using the papillary bleeding index (PBI) at baseline and 4, 8 and 12 weeks |
| Secondary outcome measures | The secondary objective was to examine the development of oral hygiene over time and to clarify whether, if, and to what extent the wear index affects the plaque index. 1. Plaque quantity measured using the plaque index (PI) at baseline and 4, 8 and 12 weeks 2. Toothbrush head wear measured using the wear index (WI) at baseline and 4, 8 and 12 weeks |
| Overall study start date | 15/08/2013 |
| Completion date | 30/06/2014 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Child |
| Lower age limit | 12 Years |
| Upper age limit | 15 Years |
| Sex | Both |
| Target number of participants | 64 |
| Total final enrolment | 64 |
| Key inclusion criteria | 1. A signed informed consent from each subject and his/her legal guardian 2. Aged between 12 and 15 years old 3. No serious medical diseases 4. Total of at least 16 teeth 5. All eight anterior teeth present and orthodontic fixed appliances 6. General good oral hygiene |
| Key exclusion criteria | 1. No multibracket appliances in situ 2. Suffering from severe periodontal diseases or gingival recession 3. More than three carious defects 4. Active periodontal treatment 5. Use of antibiotics or anti-inflammatory drugs 6. Pregnancy 7. Unreliability, lack of cooperation or other objections with the opinions of the practitioner 8. Professional tooth cleaning had been performed in the past four weeks 9. The presence of any symptoms 10. Any health-related issues 11. Participation in any other study |
| Date of first enrolment | 20/12/2013 |
| Date of final enrolment | 14/03/2014 |
Locations
Countries of recruitment
- Germany
Study participating centre
Mainz
55131
Germany
Sponsor information
University/education
Polyclinic for orthodontics
Augustusplatz 2
2nd floor, building 901
Mainz
55131
Germany
| Phone | +49 (0)6131 17 3024 |
|---|---|
| wissenschaftlicher.vorstand.um@uni-mainz.de | |
| Website | http://www.unimedizin-mainz.de/home.html?L=1 |
"ROR" |
https://ror.org/00q1fsf04 |
Funders
Funder type
Hospital/treatment centre
Private sector organisation / Universities (academic only)
- Alternative name(s)
- University Medical Center Mainz, Universitätsmedizin Mainz
- Location
- Germany
Results and Publications
| Intention to publish date | 01/03/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal The study protocol, statistical analysis plan, and other additional documents are not intended to become available online. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available because if the raw data is available but not analyzed appropriately by qualified experts, it may lead to misinterpretation of the results. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 25/11/2022 | No | Yes | ||
| Protocol file | 25/11/2022 | No | No |
Additional files
Editorial Notes
14/02/2023: The study setting has been changed from ‘Other’.
12/12/2022: Trial's existence confirmed by the Ethics Committee of the Rhineland-Palatinate Medical Association.
