Comparison Of Clinical And Radiological Success Of Pulpotomy Treatments Performed With Proroot MTA, NeoPUTTY MTA, TheraCal PT In Primary Teeth

NCT07260357 | Completed

• 1 other identifier: NecmettinEU03
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this randomized clinical trial is to compare clinical and radiological success rates of NeoPutty MTA, ProRoot MTA and TheraCal PT pulpotomy in 4-10 years old healthy pediatric patients. The main question it aims to answer is: Which of these 3 materials are best suited for pulpotomy treatment in the aspect of clinical and radiological success rates. Participants will undergo a pulpotomy treatment in primary molar teeth with one of these materials used.

Conditions

Dentin Caries

Keywords

Pulpotomy; Primary Teeth; Mineral Trioxide Aggregate

Outcome Measures

Primary Outcomes (2)

• Clinical Success Of Pulpotomy Treatments Performed With Proroot MTA, NeoPUTTY MTA, TheraCal PT In Primary Teeth

  Clinical success will be evaluated at 6- and 9-month follow-up examinations by assessing the following parameters: spontaneous pain, tenderness to percussion, swelling, sinus/fistula formation, and pathological mobility. Each parameter will be recorded as positive (present) or negative (absent). Tooth mobility will be graded according to Miller's Mobility Classification (Grades 0-3). A tooth will be considered clinically successful if all parameters are negative (no symptoms) and mobility is within Miller's Grade 0-1. Data will be aggregated and reported as the number and percentage of teeth with clinical success for each pulpotomy material group (ProRoot MTA, NeoPUTTY, and TheraCal PT).

  6 months and 9 months post-treatment

• Clinical And Radiological Success Of Pulpotomy Treatments Performed With Proroot MTA, NeoPUTTY MTA, TheraCal PT In Primary Teeths

  Radiographic success will be evaluated at 6- and 9-month follow-up visits using standardized periapical radiographs. Each radiograph will be examined for the presence or absence of the following findings: periapical radiolucency, furcal involvement, internal or external root resorption, and widening of the periodontal ligament space. Each parameter will be recorded as positive (absent pathology) or negative (presence of any pathology). Teeth showing no pathological findings (i.e., all parameters positive) will be classified as radiographically successful, whereas those showing any pathological change (negative) will be classified as radiographic failures. Evaluations will be performed independently by two blinded examiners. Data will be aggregated and reported as the number and percentage of radiographically successful teeth for each pulpotomy material group (ProRoot MTA, NeoPUTTY, and TheraCal PT).

  6 months and 9 months post-treatment

Study Arms (3)

ProRoot MTA White (Tulsa Dental Products, Tulsa, USA)

EXPERIMENTAL

Pro Root MTA Root Canal Repair Material

Other: ProRoot MTA Pulpotomy

NeoPUTTY (NuSmile, Houston, USA)

EXPERIMENTAL

Next Generatıon Pre-Mıxed Root \& Pulp Treatment Materıal

Other: NeoPUTTY MTA Pulpotomy

ThraCal PT (Bisco Dental Products, Schaumburg IL, Amerika)

EXPERIMENTAL

BISCO's TheraCal PT is a dual-cured, resin-modified calcium silicate pulpotomy treatment.

Other: TheraCal PT Pulpotomy

Interventions

ProRoot MTA Pulpotomy OTHER

Teeth were pulpotomized with Pro-Root MTA in this group.

ProRoot MTA White (Tulsa Dental Products, Tulsa, USA)

NeoPUTTY MTA Pulpotomy OTHER

Teeth were pulpotomized with Neo-Putty MTA in this group.

NeoPUTTY (NuSmile, Houston, USA)

TheraCal PT Pulpotomy OTHER

Teeth were pulpotomized with Theracal PT in this group.

ThraCal PT (Bisco Dental Products, Schaumburg IL, Amerika)

Eligibility Criteria

• Age: 4 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Primary molars with active caries and pulp exposure, assessed after intraoral periapical radiograph examination
• Presence of pulp exposure during caries excavation
• More than two-thirds of root length present
• No history of spontaneous pain
• Children aged 4-10 years with Frankl's positive or definitely positive behavior

You may not qualify if:

• Teeth with internal or external root resorption, periapical lesions, or widening of the periodontal ligament (PDL)
• Presence of sinus tracts or history of swelling
• Uncontrolled pulpal bleeding from the tooth, even after 5 minutes
• No pulp exposure during caries excavation
• Patients or parents unwilling to participate in the study

Sponsors & Collaborators

• Necmettin Erbakan University: lead
• necmettin erbakan university Scientific Research Projects (BAP): collaborator

Study Sites (1)

Necmettin Erbakan University Faculty of Dentistry

Konya, Meram, 42090, Turkey (Türkiye)

Location

Related Publications (1)

• Bossu M, Iaculli F, Di Giorgio G, Salucci A, Polimeni A, Di Carlo S. Different Pulp Dressing Materials for the Pulpotomy of Primary Teeth: A Systematic Review of the Literature. J Clin Med. 2020 Mar 19;9(3):838. doi: 10.3390/jcm9030838.

  PMID: 32204501 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Treatment selection of patients meeting the inclusion criteria was made using the randomized sealed envelope method. One envelope was created for each group and the patient was asked to choose which pulpotomy material would be used before the procedure. The procedure was performed by a single researcher (M.T.) who was receiving specialist training in pediatric dentistry. The teeth were restored with stainless steel crowns after the amputation treatment. Intraoral photographs were taken from the patients at the beginning, after cavity preparation and after the restoration was completed, and periapical radiographs were taken after the restorations were completed to control the restorations. The patients were called for control sessions at 6 and 9 months. A maximum of one periapical radiograph was taken from each tooth. The teeth were checked by 2 physicians (M.T. and H.A.) and recorded in the case report forms according to the determined clinical and radiographic evaluation criteria.

Study Record Dates

• First Submitted: July 15, 2025
• First Posted: December 3, 2025
• Study Start: January 1, 2024
• Primary Completion: October 1, 2024
• Study Completion: December 1, 2024
• Last Updated: December 3, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)