Comparing the treatment of deciduous teeth in children with the Er:YAG laser to the traditional method
| ISRCTN | ISRCTN12447217 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12447217 |
| Secondary identifying numbers | KB-547/21 |
- Submission date
- 26/06/2024
- Registration date
- 20/07/2024
- Last edited
- 19/07/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Various working methods are used in children's dental treatment. Among the standard treatment methods, among others, the classic mechanical development of caries defects using rotational instruments and the possibility of using a dental laser. The use of classical methods is associated with a high probability . The use of dental lasers, despite the sometimes longer duration of the procedure, is conducive to lowering pain and perception of dental visit as less traumatic.
The purpose of the study is to assess the parameters of the dental laser which constitute a standard in the preparation of caries defects in milk teeth in children.
Who can participate?
The study may participate in the developmental period corresponding to the period of deciduous teeth inhabited in the Polish Lower Silesian Voivodship.
What does the study involve?
Participants will be covered by an examination and conservative treatment of milk dentition using the proposed method of using dental lasers.
What are the possible benefits and risks of participating?
The expected benefits of participation in the project are minimizing the frequency of caries in the treatment of children along with minimizing stress related to dental visits.
Where is the study run from?
Wroclaw Medical University the Department of Dental Surgery (Poland)
When is the study starting and how long is it expected to run for?
November 2021 to August 2024
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Jacek Kotuła, j_kotula@poczta.onet.pl
Contact information
Public, Scientific, Principal Investigator
Wróblewskiego 4
Zielona Góra
65-012
Poland
 ORCID ID |
0000-0002-5781-6540 |
|---|---|
| Phone | +48 698680831 |
| j_kotula@poczta.onet.pl |
Study information
| Study design | Single-center interventional double-blinded randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Dental clinic, University/medical school/dental school |
| Study type | Diagnostic, Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | A randomized and split-mouth clinical trial conducted to compare the treatment of deciduous teeth in children with the Er:YAG laser to the traditional method |
| Study objectives | The study aimed to determine the optimal Er:YAG laser settings for carious lesions in the enamel and dentine of primary teeth on occlusal, tangential, and smooth surfaces |
| Ethics approval(s) |
Approved 25/11/2021, Local Ethics Committee of the Medical University of Wroclaw, Faculty of Dentistry (Passteura 1, Wroclaw, 50-361, Poland; +48 71 784 10 14; bioetyka@umw.edu.pl), ref: KB - 547/2021 |
| Health condition(s) or problem(s) studied | Treatment of carious lesions of primary teeth in children using lasers |
| Intervention | The randomized clinical split-mouth trial involved 66 teeth with deep caries in 33 subjects (female and male; age: 3–8 years). Each tooth on the test side (n=33) of the maxilla or mandible was treated with the Er:YAG laser, while the teeth on the opposite side (n=33) served as a control group (conventional treatment) . Following the administration of an adaptive visit, a dental examination was conducted using the DIAGNOcam caries diagnostic device (KaVo, Biberach, Germany) to identify occlusal and proximal caries of primary teeth. Patients presenting with carious lesions in unicuspidal teeth of similar severity were eligible for inclusion in the study. The decision as to which tooth would be treated with the conventional method and which with the laser method was determined through computerized randomization. Similarly, the method of first cavity preparation was selected by computer randomization. The computer program determined whether the first preparation would be conducted using conventional methods or with the Er:YAG laser. The initial visit did not include any form of caries treatment. Instead, the children were immediately taken through a series of adaptive visits, which were conducted following their age and individual needs. This was followed by a comprehensive dental examination, which included oral hygiene instruction, dietary guidelines, and a procedure to clean all teeth of plaque. At the subsequent visit, the children were treated with a conservative approach to the management of their milk teeth. Treatment procedures One group of patients was treated with the Er:YAG laser (MORITA AdvErL Evo, Kyoto, Japan), while the other group was treated with a turbine with diamond drills, water and air cooling, and a slow-speed tip with rose drills and air cooling. Characteristics of the conventional method In the traditional method, a turbine with blue-coated diamond drills 19 mm long in sizes 012 – 018 with water and air cooling was employed to create the cavities and work on the enamel. A slow-speed carbide tip 22 mm long in sizes 018 – 021 with air cooling was used for dentin preparation. The restorative material was glass ionomer. Characteristics of the laser settings A summary of the settings of the laser utilized for each group of cavities is presented in Table 3. The following Er:YAG laser parameters were employed in the enamel on all surfaces: a frequency of 10 Hz for cavity opening and 20 Hz for enamel modification; a pulse of energy of 160 mJ with a 400 μm diameter applicator and 230 mJ. The 600 μm diameter applicator was used to develop cavities on proximal and chewing surfaces, while on smooth surfaces (palatal and labial) of anterior teeth, 150 mJ – 600 μm and 180 mJ – 800 μm were applied. In the surface modification procedure, the energy pulse was 50 mJ and 70 mJ for 400 μm and 600 μm diameter applicators, respectively. The liquid water values oscillated between 2.5 - 3 mL/min, and the air cooling was set to 7 on a scale of 1 to 10. The parameters employed in dentin across all cavity classes were as follows: frequency 10 Hz, a pulse of energy 120 mJ with a 600 μm diameter applicator, and 150 mJ with an 800 μm diameter applicator, respectively. The liquid water was used at a rate of 2–2.5 mL/min with air cooling at 7 on a scale of 1 to 10. The pulse duration was maintained at 300 μs throughout the enamel and dentin treatment. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 1. Pulp reaction to treatment. The Pulp Vitality Tester was employed to assess dental pulp vitality. The device quantifies pulp vitality on a scale of 0 to 80 μA (0–40 μA – vital pulp; 40–80 μA – pulpitis; over 80 μA – necrotic pulp). The pulp responses of deciduous teeth were studied using both traditional and laser methods following the treatment 2. The working time for conventional and laser method for each method was recorded using a stopwatch 3. Following the conventional and laser treatment visit, patients were asked to rate their pain sensations using emoticons according to the VAS scale |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 25/11/2021 |
| Completion date | 30/08/2024 |
Eligibility
| Participant type(s) | Patient, Health professional |
|---|---|
| Age group | Child |
| Lower age limit | 3 Years |
| Upper age limit | 8 Years |
| Sex | Both |
| Target number of participants | 47 |
| Total final enrolment | 97 |
| Key inclusion criteria | 1. Children who had visited a dental office for the first time in their lives for a dental examination and possible conservative treatment 2. The patients in the study were healthy children who were not taking any medication 3. They also did not report any pain when coming to the office 4. The patients were aged between 3 and 8 years 5. The patients exhibited unicuspidal deciduous teeth with deep caries |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 25/11/2021 |
| Date of final enrolment | 26/06/2024 |
Locations
Countries of recruitment
- Poland
Study participating centre
Wroclaw
50-367
Poland
Sponsor information
University/education
Department and Department of Dental Surgery
Krakowska 26
Wroclaw
50-425
Poland
| Phone | +48 71 784 02 51 |
|---|---|
| chir.stom@umw.edu.pl | |
| Website | https://en.umw.edu.pl |
"ROR" |
https://ror.org/01qpw1b93 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 25/12/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | We planned the publication in the JCM Journal |
| IPD sharing plan | The datasets generated during the curent study will be available upon request from DSS Agnieszka Milc agnieszka.milc@dens-albus.pl |
Editorial Notes
19/07/2024: Trial's existence confirmed by Bioethics Committee of the Wrocław Medical University.
