Plain English Summary
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
Trial website
Contact information
Type
Scientific
Primary contact
Dr Nabih Raslan
ORCID ID
http://orcid.org/0000-0001-9967-9575
Contact details
Department of paediatric Dentistry
Faculty of Medical Dentistry
Tishreen University
Lattakia
00963
Syria
Type
Scientific
Additional contact
Dr Hasan Ali
ORCID ID
http://orcid.org/0000-0001-6959-7552
Contact details
Department of paediatric Dentistry
Faculty of Medical Dentistry
Tishreen University
Lattakia
00963
Syria
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
U1111-1222-2654
Study information
Scientific title
Direct pulp capping (DPC) in primary molars using three antibiotics combination 3mix-mp: a randomized controlled pilot trial
Acronym
Study hypothesis
Is conducting a large randomized clinical trial feasible and what is the proper sample size?
Ethics approval
The institutional review board of Tishreen University, 02/08/2016, Approval No. 3179
Study design
Pilot randomized double-blind parallel two-arm control trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Drug names
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 trial start date
17/08/2016
Overall trial end date
23/06/2017
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
20
Participant exclusion criteria
Any clinical or radiographic signs indicating non-vital teeth
Recruitment start date
20/08/2016
Recruitment end date
16/12/2016
Locations
Countries of recruitment
Syria
Trial participating centre
Tishreen University
Department of Pediatric Dentistry
Lattakia
00963
Syria
Sponsor information
Organisation
Tishreen University
Sponsor details
Department of Paediatric Dentistry
Faculty of Medical Dentistry
Lattakia
00963
Syria
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Tishreen University
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned submission to Pilot and Feasibility Studies journal as soon as trial is registered.
IPD sharing statement
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.
Intention to publish date
31/12/2018
Participant level data
Other
Basic results (scientific)
Publication list