Testing a laser tool for finding cavities in kids' molars
| ISRCTN | ISRCTN97265287 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN97265287 |
- Submission date
- 22/07/2024
- Registration date
- 29/07/2024
- Last edited
- 29/07/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Dental caries, or tooth decay, is a common problem that affects many people worldwide, especially on the chewing surfaces of the back teeth (molars). Early and accurate detection of caries is crucial for effective treatment and preventing further damage. This study aims to evaluate a tool called DIAGNOdent, which uses laser technology to detect caries on the chewing surfaces of teeth. The researchers want to see if this tool is as good as or better than traditional methods of visual examination in detecting different stages of caries.
Who can participate?
Children who are 7 years old and have first permanent molars that do not have any existing restorations or fissure sealants can participate. Participants must be generally healthy and have not had fluoride varnish treatment in the past 6 months.
What does the study involve?
Participants will have their teeth examined using both traditional visual methods and the DIAGNOdent laser tool. The DIAGNOdent tool will measure how much the teeth fluoresce (glow) under a laser light, which helps in detecting caries. The researchers will compare the results from both methods to see how well DIAGNOdent works in identifying carious lesions.
What are the possible benefits and risks of participating?
The benefits of participating include early detection of carious lesions, which can help in planning effective treatments and potentially preventing more serious dental issues. The risks are minimal but may include slight discomfort during the examinations or the need for additional dental visits.
Where is the study run from?
Kalamoun University (Syria)
When is the study starting and how long is it expected to run for?
February 2015 to March 2015
Who Is funding the study?
University of Kalamoon (Syria)
Who Is the main contact?
Dr Massa Mahayni, massa1.mahayni@damascusuniveristy.edu.sy
Contact information
Public, Scientific, Principal Investigator
Mezzah
Damascus
445
Syria
 ORCID ID |
0009-0002-2037-1514 |
|---|---|
| Phone | +963 (0)941113368 |
| massa1.mahayni@damascusuniversity.edu.sy |
Study information
| Study design | Clinical diagnostic study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Comparative diagnostic study |
| Study setting(s) | Dental clinic, University/medical school/dental school |
| Study type | Diagnostic, Efficacy |
| Participant information sheet | 45820_PIS.pdf |
| Scientific title | Evaluating the efficacy of DIAGNOdent laser fluorescence in detecting occlusal caries: a clinical study |
| Study acronym | EDL-FIND |
| Study objectives | The DIAGNOdent laser fluorescence method is more effective than traditional visual examination in detecting occlusal caries in permanent molars of children, particularly at different thresholds for caries severity. |
| Ethics approval(s) | Ethics approval not required |
| Ethics approval additional information | The study titled “Evaluating the Efficacy of DIAGNOdent Laser Fluorescence in Detecting Occlusal Caries: A Clinical Study” does not require formal ethics approval based on the following reasons: Non-Invasive and Routine Procedures: The research involves the use of the DIAGNOdent laser fluorescence device to detect occlusal caries, which is a non-invasive diagnostic procedure commonly used in dental practice. No new or experimental interventions are being tested. Standard Clinical Practice: The study utilizes standard diagnostic tools and procedures that are already part of routine clinical practice. It does not involve experimental treatments or procedures that would warrant additional ethical scrutiny. No Risk of Harm: The study does not pose any physical, psychological, or emotional risk to participants. The diagnostic procedures are safe, and the study does not involve any invasive or potentially harmful interventions. Use of Existing Data: The research does not involve the collection of sensitive personal data beyond what is typically collected in a standard dental diagnostic setting. Any data collected is anonymized and used solely for the purpose of evaluating the efficacy of the diagnostic tool. Informed Consent: All participants were provided with clear information about the study and provided with informed consent before participating. This ensures transparency and respects participants’ rights. Compliance with Regulations: The study complies with relevant regulations and guidelines for clinical research. It follows standard practices and does not deviate from accepted procedures that are already ethically vetted in routine clinical settings. In summary, because the study involves standard diagnostic procedures without introducing new risks or interventions, and since informed consent is obtained, it does not necessitate formal ethics approval. |
| Health condition(s) or problem(s) studied | Occlusal caries |
| Intervention | The study will evaluate the efficacy of the DIAGNOdent laser fluorescence method for detecting occlusal caries compared to visual examination. The methodology involves: 1. Participant Selection: A total of 120 first permanent molars from 30 children aged 7 years will be examined. Participants will be selected from the clinics of the Faculty of Dentistry at Kalamoun University. 2. Diagnostic Procedures: 2.1. Visual Examination: The occlusal surfaces will be examined using a dental mirror and a World Health Organization (WHO) periodontal probe. Lesions will be classified into three grades: sound (Grade 0), white/brown spot lesions (Grade 1), and cavitated caries lesions (Grade 2). 2.2. DIAGNOdent Examination: The DIAGNOdent laser fluorescence device will be used to assess the fluorescence levels on the same occlusal surfaces. Readings will be classified into three categories based on the manufacturer's cut-off points: sound (0-5), histological enamel caries (6-14), and histological dentinal caries (≥15). 3. Data Collection: The results from both diagnostic methods will be recorded. Sensitivity, specificity, accuracy, and inter-method agreement will be analyzed to determine the performance of DIAGNOdent compared to visual examination. 4. Analysis: The study will compare the DIAGNOdent readings with visual examination results using statistical methods, including sensitivity, specificity, and Cohen’s kappa coefficient to assess inter-method reliability. |
| Intervention type | Other |
| Primary outcome measure | Occlusal caries detection is measured using DIAGNOdent laser fluorescence and visual examination at baseline |
| Secondary outcome measures | 1. Sensitivity and specificity of DIAGNOdent measured using the DIAGNOdent laser fluorescence device and visual examination at baseline 2. Accuracy of DIAGNOdent measured by comparing DIAGNOdent readings with visual examination results at baseline 3. Inter-method agreement between DIAGNOdent and visual examination measured using Cohen's kappa coefficient at baseline |
| Overall study start date | 23/02/2015 |
| Completion date | 29/03/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 7 Years |
| Upper age limit | 7 Years |
| Sex | Both |
| Target number of participants | 120 first permanent molars from 30 children |
| Total final enrolment | 120 |
| Key inclusion criteria | 1. Children aged 7 years 2. Participants must have first permanent molars without occlusal restorations or fissure sealants 3. Participants must have visible occlusal caries or be in need of evaluation for caries 4. Participants must be in generally good health with no significant systemic diseases 5. Participants must not have received fluoride varnish treatment within the past 6 months |
| Key exclusion criteria | 1. Participants with significant systemic diseases that could affect the study's outcomes or procedures 2. Participants who have received fluoride varnish treatment within the past 6 months 3. Participants with occlusal restorations, fissure sealants, or hypoplastic pits on the first permanent molars 4. Participants whose guardians are unable or unwilling to provide informed consent 5. Participants who are unable to cooperate with the study procedures or examinations |
| Date of first enrolment | 01/03/2015 |
| Date of final enrolment | 03/03/2015 |
Locations
Countries of recruitment
- Syria
Study participating centre
Damascus
222
Syria
Sponsor information
University/education
Deit Attiyeh
damascus
222
Syria
| Phone | +963 (0)999 33 78 (11) |
|---|---|
| info@uok.edu.sy | |
| Website | http://www.uok.edu.sy/ |
"ROR" |
https://ror.org/02g847680 |
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | 02/08/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Dr Massa Mahayni (massa.mahayni@gmail.com). Type of data shared: anonymized diagnostic test results and demographic information Participant consent: informed consent was obtained from all participants, ensuring their awareness of data usage. Data anonymization: all participant data will be fully anonymized to protect personal information. Ethical/legal restrictions: there are no ethical or legal restrictions anticipated for sharing the anonymized data. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 23/07/2024 | No | Yes | ||
| Protocol file | 26/07/2024 | No | No | ||
| Statistical Analysis Plan | 26/07/2024 | No | No |
Additional files
Editorial Notes
29/07/2024: Study's existence confirmed by the Syrian Private University.
