Removing caries with chemical agents
| ISRCTN | ISRCTN21124259 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN21124259 |
| Secondary identifying numbers | DUUS-1634-08062023 |
- Submission date
- 09/10/2024
- Registration date
- 22/10/2024
- Last edited
- 22/10/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Chemomechanical caries removal (CMCR) is a non-invasive dental procedure that uses chemicals to soften and remove decayed tooth tissue. Numerous CMCR agents have been developed and recent studies have investigated the use of bromelain in CMCR. The aim of this study was to compare the effectiveness of bromelain enzyme-based gels in three concentrations (10, 15 and 20%) with 2.4% sodium hypochlorite gel in CMCR.
Who can participate?
Children aged 6 to 10 years with caries
What does the study involve?
The bromelain gels were freshly prepared using different concentrations of bromelain (10, 15 and 20%), and the bromelain gel or sodium hypochlorite was applied to the cavity and left for 60 seconds. Once the gel turned cloudy, it was carefully scraped away with a spoon excavator, avoiding pressure. This procedure was repeated with all gels until the gel applied in the cavity remained clear. The number of applications required for complete caries removal and the total time taken were recorded. Finally, the cavities were restored using glass-ionomer cement.
What are the possible benefits and risks of participating?
This study will remove caries with a minimally invasive technique without the stress and anxiety which may associated with traditional methods of removing caries.
Where is the study run from?
Damascus University (Syria)
When is the study starting and how long is it expected to run for?
May 2023 to July 2024
Who is funding the study?
Damascus University (Syria)
Who is the main contact?
Contact information
Public, Scientific, Principal Investigator
Damascus
Damascus
00963
Syria
| Phone | +963 (0)50401111 |
|---|---|
| dana98akkad@gmail.com |
Study information
| Study design | Randomized four-arm active-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | University/medical school/dental school |
| Study type | Treatment |
| Scientific title | Efficacy of different concentrations of bromelain gel in removing carious lesions in primary teeth using the chemical-mechanical caries removal (CMCR) technique: an in vivo study |
| Study objectives | There is no significant difference in efficacy between the four groups of bromelain gel in different three concentrations and the sodium hypochlorite gel 2.4% group |
| Ethics approval(s) |
Approved 08/06/2023, Ethical Committee and the Board of Scientific Research at the Faculty of Dentistry, University of Damascus (Damascus, Damascus, 00963, Syria; -; mohannad1.laflouf@damascusuniversity.edu.sy), ref: DUUS-1634-08062023 |
| Health condition(s) or problem(s) studied | Caries |
| Intervention | A total of 60 primary canines were included in this clinical trial. Bromelain gel at concentrations formulated pharmaceutically for this study (10%, 15%, and 20%) was used and compared with 2.4% sodium hypochlorite gel in the chemical-mechanical caries removal (CMCR) technique. Each patient was randomly allocated to one of four groups using the website http://www.random.org. The removal of the lesion was confirmed by the clinician performing the application, a blinded external researcher, and a caries detector dye. The study evaluated the number of applications required for complete caries removal for each agent and the time taken for caries removal. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | The number of applications required for the removal of caries to be completed was recorded and the total time taken was measured using a digital timer |
| Secondary outcome measures | Pain and acceptability of the process measured using the Sound, Eye and Motor (SEM) Scale after the end of the treatment |
| Overall study start date | 01/05/2023 |
| Completion date | 01/07/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Years |
| Upper age limit | 10 Years |
| Sex | Both |
| Target number of participants | 60 |
| Total final enrolment | 60 |
| Key inclusion criteria | 1. Healthy children with no systemic diseases, such as diabetes, congenital heart disease, or autoimmune disorders, are generally considered for routine dental care without additional medical considerations. 2. The child's level of behavior was positive and definitely positive according to Frankl’s behavior rating scale. 3. With upper primary canine teeth exhibit class V carious lesions involving dentin on the vestibular surfaces, which do not involve the pulp while all teeth are vital and non-accidental, with no clinical signs of pulp involvement. 4. There are no malformations or developmental abnormalities of the teeth. |
| Key exclusion criteria | 1. History of allergy to any of the materials used 2. Systemic diseases 3. Deep caries involving the pulp 4. Presence of edema or a fistula associated with the decayed tooth |
| Date of first enrolment | 12/06/2023 |
| Date of final enrolment | 01/07/2024 |
Locations
Countries of recruitment
- Syria
Study participating centre
00963
Syria
Sponsor information
University/education
Damascus
Damascus
00963
Syria
| Phone | +963 |
|---|---|
| not@provided.com | |
| Website | http://ror.org/03m098d13 |
"ROR" |
https://ror.org/03m098d13 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- University of Damascus, جَامِعَةُ دِمَشْقَ, DU
- Location
- Syria
Results and Publications
| Intention to publish date | 01/07/2025 |
|---|---|
| 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 are/will be available upon request from rmakkieh@yahoo.com. IPD will be shared in accordance with ethical guidelines and the consent of the patients who participated in the study. |
Editorial Notes
22/10/2024: Study's existence confirmed by the Faculty of Dentistry, University of Damascus.
