Outcomes of Partial Pulpotomy VS Ful Pulpotomy Using MTA in Primary Teeth

July 16, 2026 updated by: Jordan University of Science and Technology

Clinical and Radiographic Success of MTA Full Pulpotomy VS MTA Partial Pulpotomy; a Split-mouth Randomized Controlled Trial.

Background: Full pulpotomy has been the treatment of choice for normal or reversibly inflamed exposed pulps in primary molars. However, this approach has its own disadvantages and may be simplified down to a more conservative type of pulpotomies which is the "partial pulpotomy".

Though the literature is still lacking high quality studies on partial pulpotomy in primary molars.

Since MTA has demonstrated the highest success in the literature in comparison to other pulpotomy agents, it is going to be the choice in this trial. Aims: This study aims to investigate the success of partial vs full pulpotomies using MTA in vital primary molars without irreversible pulpitis. Methods: This is an RCT with a split-mouth design, comparing the radiographic and clinical changes of full vs partial MTA-pulpotomies over a one-year period in primary molars. The study will involve 25 healthy children, aged 4-8 years, who are attending JUST postgraduate clinics for dental treatment. Children with pair-matched primary molars that are present with advanced caries exposing the pulp or requiring pulpotomy will be enrolled. Teeth will be randomly assigned to either full or partial pulpotomy. Both procedures will be conducted under LA and rubber dam isolation.

The whole coronal pulp is going to be removed in full pulpotomy compared to 1-3 mm of the coronal pulp in partial pulpotomy. For both procedures, MTA will be placed, then the tooth will be restored with IRM, with the SSC as the final restoration. Afterwards, participants are going to be followed up clinically every 3 months, and radiographically every 6 months over the study period.

Expected results: partial pulpotomy is expected to be a viable alternative to the full pulpotomy, Partial pulpotomy might be recommended as a treatment option since it is more conservative to the pulp and involves less damage to the hard tissues rendering the tooth easier to restore. More importantly, the procedure is assumed to be less painful and more acceptable to young children with limited cooperation

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Jordan
      • Irbid, Jordan, 22110
        • Jordan University of Science and Technology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Children aged 4-8 years
  • Medically fit or with mild systemic disease (ASA I or II),
  • Able to attend all follow-up appointments
  • Children with deeply carious pair-matched primary molars with normal or reversibly inflamed pulp that are indicated for pulpotomy (with almost radiographic caries exposure of the pulp).
  • Children who are willing to take part in the study
  • Children with valid parental consent

Exclusion Criteria:

  • History of lingering or nocturnal pain, any clinical sign of pulp degeneration such as pathological mobility, tenderness to percussion/palpation, presence of fistulae or odontogenic facial swelling.
  • The presence of radiologic signs of pulp infection/necrosis such as pathological external root resorption, internal resorption, bifurcation of apical radiolucency.
  • Teeth with developmental dental anomalies, unrestorable crown or with advanced physiologic root resorption (> 1/3).
  • Children with known allergy to any of the materials or medicaments used in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Full pulpotomy
Procedure: NeoPUTTY MTA
Use for partial pulpotomy in primary molars
Experimental: Partial pulpotomy
Procedure: NeoPUTTY MTA
Use for partial pulpotomy in primary molars

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Clinical success
Time Frame: 12 months
Clinical evaluation will include the following parameters: pain, mobility, tenderness to percussion, periodontal pocket formation, gingival inflammation, and sinus tract formation. Each tooth was scored from 1 to 4 according to the criteria by Zurn and Seale 2008
12 months
Radiographic Success
Time Frame: 12 months
Radiographic evaluation will include the following parameters: periapical or furcal radiolucency, internal resorption, and external resorption. Each tooth was scored from 1 to 4 according to the criteria by Zurn and Seale 2008
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jordan University of Science and Technology

Publications and helpful links

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General Publications

Helpful Links

Study record dates

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Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 27, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 16, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 21, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 21, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20240554

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Data will be available for sharing upon reasonable request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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