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
A randomized controlled trial of ProRoot MTA, OrthoMTA and RetroMTA for partial pulpotomy in permanent teeth
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
Yonsei University Dental Hospita, ref: 2-2012-0053
Single centre randomised single-blind controlled study
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Permanent teeth with advanced caries or dental trauma with pulp exposure
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.
1. ProRoot MTA
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
Overall trial start date
Overall trial end date
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
Target number of participants
Participant exclusion criteria
Crown fracture and pulp necrosis
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Yonsei University Dental Hospital
50-1 Yonsei-ro Seodaemungu
Yonsei Dental Hospital
Ministry of Health and Welfare
Ministry of Health and Welfare, Taiwan, MOHW
Funding Body Type
Funding Body Subtype
National Research Foundation of Korea
Funding Body Type
private sector organisation
Funding Body Subtype
Results and Publications
Publication and dissemination plan
International endodontic journal (plan)
Intention to publish date
Participant level data
Available on request
Results - basic reporting