Condition category
Oral Health
Date applied
11/10/2018
Date assigned
25/10/2018
Last edited
31/10/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

http://www.tishreen.edu.sy/

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

Publication citations

Additional files

Editorial Notes

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"