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

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: Active, not recruiting
• Conditions: Pulp Therapy in Primary Molars
• Intervention / Treatment: Procedure: NeoPUTTY MTA

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Clinical success	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	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

• Sponsor: Jordan University of Science and Technology

Publications and helpful links

General Publications

• Coll JA, Dhar V, Chen CY, Crystal YO, Guelmann M, Marghalani AA, AlShamali S, Xu Z, Glickman GN, Wedeward R. Use of Vital Pulp Therapies in Primary Teeth 2024. Pediatr Dent. 2024 Jan 15;46(1):13-26.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: June 27, 2026
• First Submitted That Met QC Criteria: July 16, 2026
• First Posted (Actual): July 21, 2026

Study Record Updates

• Last Update Posted (Actual): July 21, 2026
• Last Update Submitted That Met QC Criteria: July 16, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Other Study ID 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