Direct pulp capping in primary molars: a feasibility study
| ISRCTN | ISRCTN10402878 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10402878 |
| Secondary identifying numbers | U1111-1222-2654 |
- Submission date
- 11/10/2018
- Registration date
- 25/10/2018
- Last edited
- 17/11/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Exposures of the dental pulp (the centre of the tooth) are common in dental practice and can be challenging especially in primary (baby) teeth. Direct pulp capping (DPC) is a technique used to cover the exposed pulp. It is still controversial as a treatment. However, calcium hydroxide (CH) is considered the gold standard in dental pulp treatments. The introduction of a combination of antibiotics could be promising in pulp treatments. However, improving DPC outcomes would provide an easier and less invasive treatment option for pulp exposures in these teeth. The aim of this study is to assess the feasibility of conducting a future trial on DPC using 3Mix-MP (triple antibiotic paste) compared with calcium hydroxide, and to estimate the number of participants needed for the main trial on the basis of the success rate.
Who can participate?
Children who have primary molars (back teeth) with large carious lesions (cavities) that could be restored with composite
What does the study involve?
The participants’ teeth are randomly allocated into two groups to be treated with DPC with either 3Mix-MP or calcium hydroxide (CH). All teeth are restored with composite resin and assessed at 3 and 6 months after treatment.
What are the possible benefits and risks of participating?
Treating these teeth could prevent inflammation/abscesses and the associated signs like pain and swelling. No harms are encountered since all failed cases are treated with another method (non-instrumental endodontic treatment or traditional pulpectomy).
Where is the study run from?
Tishreen University (Syria)
When is the study starting and how long is it expected to run for?
August 2016 to June 2017
Who is funding the study?
Tishreen University (Syria)
Who is the main contact?
1. Dr Nabih Raslan
2. Dr Hasan Ali
Contact information
Scientific
Department of paediatric Dentistry
Faculty of Medical Dentistry, Tishreen University
Lattakia
00963
Syria
 ORCID ID |
0000-0001-9967-9575 |
|---|
Scientific
Department of paediatric Dentistry
Faculty of Medical Dentistry, Tishreen University
Lattakia
00963
Syria
| ORCID ID |
0000-0001-6959-7552 |
|---|
Study information
| Study design | Pilot randomized double-blind parallel two-arm control trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Direct pulp capping (DPC) in primary molars using three antibiotics combination 3mix-mp: a randomized controlled pilot trial |
| Study objectives | Is conducting a large randomized clinical trial feasible and what is the proper sample size? |
| Ethics approval(s) | The institutional review board of Tishreen University, 02/08/2016, Approval No. 3179 |
| Health condition(s) or problem(s) studied | Management of large carious lesions in primary teeth |
| Intervention | Twenty molars in eight cooperative healthy children were randomly allocated into two groups using a simple randomization process. In both groups, teeth were anesthetized and isolated with a rubber dam. All carious tissues were removed using a small round bur mounted on a high-speed handpiece and copious water supply. After observing an exposure site, a cotton pellet soaked with sodium hypochlorite was applied for five minutes.The dressing agent was chosen randomly and the teeth were divided into two groups: 3Mix-MP (Group A) and calcium hydroxide powder mixed with saline CH (Group B). The dressing agent was prepared in creamy form and was applied to the exposure site before it was gently pressed into a thin layer on the cavity floor using a cotton pellet. The agent was covered with a thin layer of light cured calcium hydroxide. Composite resin restorations were placed, and then were finished after removing the rubber dam with diamond finishing burs; consequently, polishing was performed using silicone polishers. The participants were asked to attend follow-up examination, and were clinically evaluated at 3 and 6 months post-treatment and were evaluated radiographically at 6 months. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Feasibility, estimated using the following measurements: 1. Proportion of eligible children among those examined, calculated after completion of the assigned number of participants 2. Proportion of children who completed the 6-month follow-up among those randomized, calculated after completion of the assigned period |
| Secondary outcome measures | Success rates of the materials, which will be used to calculate the sample size for the definitive randomized controlled trial. Criteria used: absence/presence of clinical and radiographic signs, proportions calculated using simple formulas. Measured at the end of the treatment session as a baseline; the participants were clinically evaluated at 3 and 6 months post-treatment and evaluated radiographically after 6 months |
| Overall study start date | 17/08/2016 |
| Completion date | 23/06/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | Both |
| Target number of participants | 20 |
| Total final enrolment | 17 |
| Key inclusion criteria | 1. Cooperative healthy children 2. Vital primary molars with large carious lesions that could be restored with composite 3. No history of spontaneous pain, pathologic mobility, redness or swelling of the vestibule, draining sinus tracts, or sensitivity to vestibular palpation 4. Absence of internal or external root resorption or inter-radicular/apical radiolucency 5. Both children and their parents had to be able to attend a 6-month follow-up procedure |
| Key exclusion criteria | Any clinical or radiographic signs indicating non-vital teeth |
| Date of first enrolment | 20/08/2016 |
| Date of final enrolment | 16/12/2016 |
Locations
Countries of recruitment
- Syria
Study participating centre
Lattakia
00963
Syria
Sponsor information
University/education
Department of Paediatric Dentistry
Faculty of Medical Dentistry
Lattakia
00963
Syria
| Website | http://www.tishreen.edu.sy/ |
|---|---|
"ROR" |
https://ror.org/04nqts970 |
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | 31/12/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned submission to Pilot and Feasibility Studies journal as soon as trial is registered. |
| IPD sharing plan | The datasets generated and/or analysed during this study will be included in the subsequent results publication. Individual participant data that underlie the results, after deidentification (text, tables, figures, and appendices), would be available immediately after publication from raslan.nabih@tishreen.edu.sy. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 04/02/2021 | 27/09/2021 | Yes | No | |
| Abstract results | P026 | 01/09/2019 | 17/11/2023 | No | No |
Editorial Notes
17/11/2023: Publication reference added.
27/09/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
31/10/2018: The public title has been changed from "Direct pulp capping in primary molars" to "Direct pulp capping in primary molars: a feasibility study"
