Condition category
Oral Health
Date applied
29/10/2018
Date assigned
31/10/2018
Last edited
31/10/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Vital baby teeth with deep caries (decay and crumbling) can be treated in a variety of ways. When exposure of the pulp (the centre of the tooth) occurs in these teeth, a method called direct pulp capping (DPC) may be an excellent treatment of choice, as it might prevent unnecessary loss of the tooth structure. DPC builds a barrier over the site of exposure to protect the pulp. Calcium hydroxide is commonly used for DPC. However, using a combination of three antibiotics, caled 3Mix-MP, could reduce the inflammation and infection, and enhance the healing of the pulp. This study aims to compare the effectiveness of using 3Mix-MP and calcium hydroxide for DPC.

Who can participate?
Children who have primary molars with large caries

What does the study involve?
Chosen teeth are randomly allocated into two groups for DPC treatment with either 3Mix-MP or calcium hydroxide (CH). All teeth are assessed at 3, 6, 9 and 12 months after treatment and will be assessed radiographically after 6 and 12 months.

What are the possible benefits and risks of participating?
The treatment may prevent inflammation and abscesses, along with symptoms such as pain and swelling.
There are no known risks to participants, as any failed treatments will be re-done using another method.

Where I the study run from?
Department of Pediatric Dentistry, Tishreen University Latakia (Syria)

When is the study starting and how long is it expected to run for?
July 2016 to February 2019

Who is funding the study?
Tishreen University (Syria)

Who is the main contact?
1. Dr. Nabih Raslan (rasln.nabih@tishreen.edu.sy)
2. Dr. Hasan Ali (hasan.h.ali@outlook.com)


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

REF: 179/20

Study information

Scientific title

Direct pulp capping (DPC) in primary molars using a combination of three antibiotics (3Mix-MP): a randomized parallel controlled trial

Acronym

Direct pulp capping (DPC)

Study hypothesis

Is using 3mix-mp in direct pulp capping in primary molars more effective than using calcium hydroxide?

Ethics approval

The Institutional Review Board of Tishreen University, 02/08/2016, Approval No. 3179

Study design

Interventional double-blind two-arm randomised parallel controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Management of large carious lesions in primary teeth

Intervention

Participants are randomly allocated to either group A or group B using a simple randomisation technique.
Group A receive direct pulp capping using 3Mix-MP, whereas group B receive direct pulp capping using calcium hydroxide.
Participants are asked to attend follow-up examinations, with clinical evaluations at 3, 6, 9 and 12 months post-treatment and radiographic evaluations at 6 and 12 months.



Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measure

Clinical success rate of the materials, with treatment considered to be a success if the following clinical signs are absent:
1. Spontaneous pain
2. Redness or soft tissue swelling
3. Mobility
4. Draining sinus tracts
5. Sensitivity to vestibular palpation
Teeth will be assessed clinically at the baseline and 3, 6, 9 and 12 months post-treatment.

Secondary outcome measures

Radiographic success rate of the materials, with the treatment considered to be a success if the following radiographic signs are absent:
1. Internal or external pathological root resorption
2. Inter-radicular/periapical radiolucency
Teeth will be assessed radiographically at the baseline and at 6 and 12 months post-treatment.

Overall trial start date

17/07/2016

Overall trial end date

15/02/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Cooperative healthy children
2. Aged 5-11 years
3. Vital primary molars with large carious lesions that could be restored with composite
4. No history of spontaneous pain, pathological mobility, redness or swelling of the vestibule, draining sinus tracts, or sensitivity to vestibular palpation
5. Absence of internal or external root resorption or inter-radicular/apical radiolucency
6. Both children and their parents are able to attend a 12-month follow-up procedure

Participant type

Healthy volunteer

Age group

Child

Gender

Both

Target number of participants

36

Participant exclusion criteria

Any clinical or radiographic signs indicating non-vital teeth

Recruitment start date

15/08/2017

Recruitment end date

25/03/2018

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

Not defined

Funder name

Tishreen University, Latakia. Syria (ref: 4075/20).

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal

IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr. Nabih Raslan (raslan.nabih@tishreen.edu.sy), from 3 months after publication up to 3 years. Data will be available for researchers who provide a methodological sound proposal.

Intention to publish date

15/04/2019

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes