Condition category
Oral Health
Date applied
24/02/2016
Date assigned
25/02/2016
Last edited
25/02/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
A partial pulpotomy is a dental procedure where the diseased part of the pulp of a tooth (the inside of the tooth containing nerves, blood vessels and connective tissue) is removed and the gap filled with a type of medicate filling. It is hoped that by only removing part of the pulp, the pulp that remains stays alive (and therefore keeping the tooth alive as well). This study compares the performance of three different kinds of filling, namely ProRoot MTA (the usual treatment) OrthoMTA and RetroMTA when placed in permanent teeth.

Who can participate?
Patients that need to have a partial pulpotomy.

What does the study involve?
Participants are randomly allocated to one of three groups. Those in group 1 (control) have a partial pulpotomy and are treated with proRoot MTA. Those in group 2 have a partial pulpotomy and are treated with OrthoMTA. Those in group 3 have a partial pulpotomy and are treated with RetroMTA. Clinical examination and radiographic comparisons are carried out 1, 3, 6 and 12 months after the treatment.

What are the possible benefits and risks of participating?
There is a possibility that partial pulpotomy treated with these MTA materials may help to save the vital pulp without root canal treatment. There is a small risk of pulp canal narrowing after this type of procedure.

Where is the study run from?
Yonsei University Dental Hospital (South Korea)

When is the study starting and how long is it expected to run for?
December 2012 to October 2015

Who is funding the study?
Ministry of Health and Welfare (South Korea)

Who is the main contact?
Professor Yooseok Shin
densys@yuhs.ac

Trial website

Contact information

Type

Scientific

Primary contact

Prof Yooseok Shin

ORCID ID

http://orcid.org/0000-0003-1121-2570

Contact details

Yonsei Dental Hospital 619
50-1 Yonsei-ro
Seodaemun-gu
Seoul
03722
Korea
South
+82-2-2228-2972
densys@yuhs.ac

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A randomized controlled trial of ProRoot MTA, OrthoMTA and RetroMTA for partial pulpotomy in permanent teeth

Acronym

Study hypothesis

The clinical and radiographic outcomes of partial pulpotomy using ProRoot MTA, OrthoMTA and RetroMTA might be shown differences on exposed pulp tissue of human permanent teeth

Ethics approval

Yonsei University Dental Hospita, ref: 2-2012-0053

Study design

Single centre randomised single-blind controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Permanent teeth with advanced caries or dental trauma with pulp exposure

Intervention

Participants have vital permanent teeth with advanced caries or dental trauma with pulp exposure that require root canal treatment. After application of local anaesthesia and rubber dam isolation, the carious dentin was completely removed in these teeth. After the partial pulp amputation (partial pulpotomy), the preparation is thoroughly disinfected with NaOCl.

After the control of hemorrhage. MTA materials were used in pulp sites. All procedure were performed with one visit treatment. Participants are randomly allocated to one of the three following groups:

1. Control group - participants receive proRoot MTA
2. Experimental group 1 - participants receive OrthoMTA
3. Experimental group 2 - participants receive RetroMTA

Clinical examination and radiographic comparison were carried out at 1, 3, 6 and 12 months after the treatment.

Intervention type

Drug

Phase

Phase IV

Drug names

1. ProRoot MTA
2. OrthoMTA
3. RetroMTA

Primary outcome measures

Patients are recalled for the following clinical and radiographical examinations:

1. Spontaneous pain and/or sensitivity (Visual Analogue Scale ≥ 1, symptomatic)
2. Periodontal conditions (gingival redness and swelling)
3. Periapical radiolucency
4. Pathological root resorption

Assessed at 1, 3, 6 and 12 months.

Secondary outcome measures

N/A

Overall trial start date

10/12/2012

Overall trial end date

30/10/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Tooth has no history of spontaneous pain
2. Tooth has acute minor pain that subsides with analgesics
3. Tooth has no discomfort to percussion, no vestibular swelling and no mobility
4. Radiographic examination shows normal appearance of periodontal attachment
5. Pulp is exposed during caries removal or subsequent to recent trauma
6. Tissue appears vital
7. Bleeding from the pup excision site stops with NaOCl within 5 minutes

Participant type

Patient

Age group

All

Gender

Both

Target number of participants

82 patients

Participant exclusion criteria

Crown fracture and pulp necrosis

Recruitment start date

10/12/2012

Recruitment end date

30/09/2014

Locations

Countries of recruitment

Korea, South

Trial participating centre

Yonsei University Dental Hospital
50-1 Yonsei-ro Seodaemungu
Seoul
03722
Korea, South

Sponsor information

Organisation

Yonsei Dental Hospital

Sponsor details

50-1 Yonsei-ro
Seodaemun-gu
Seoul
03722
Korea
South
+82-2-2228-2972
densys@yuhs.ac

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

Ministry of Health and Welfare

Alternative name(s)

Ministry of Health and Welfare, Taiwan, MOHW

Funding Body Type

government organisation

Funding Body Subtype

federal/national government

Location

Taiwan

Funder name

National Research Foundation of Korea

Alternative name(s)

NRF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Korea, South

Results and Publications

Publication and dissemination plan

International endodontic journal (plan)

Intention to publish date

01/04/2016

Participant level data

Available on request

Results - basic reporting

Publication summary

This study showed that the success rates of ProRoot MTA, OrthoMTA and RetroMTA are indistinctive under any conditions, suggesting that the newly introduced MTA materials can be useful for partial pulpotomy in permanent teeth

Publication citations

Additional files

Editorial Notes