Clinical and Radiographic Outcomes of Pulpotomy in Teeth with Different Symptoms and Root Stages

NCT06874088 | Completed

• 2 other identifiers: B.30.2.ATA.0.01.00/13atatürk üniversitesi
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Pulpotomy is a vital pulp therapy (VPT) method used to maintain pulp vitality by removing inflamed or infected coronal pulp tissue while preserving the health and function of radicular pulp. This procedure supports root development in young permanent teeth and helps prevent long-term complications associated with apexogenesis. Recent studies indicate that pulpotomy can achieve success rates exceeding 90%, even in cases of symptomatic irreversible pulpitis, challenging traditional contraindications. Notably, this high success rate has been observed in both immature and mature permanent teeth, expanding the applicability of pulpotomy across different developmental stages. Modern materials such as Mineral Trioxide Aggregate (MTA) and Biodentine™ have been widely adopted in regenerative dentistry due to their biocompatibility and superior sealing properties. These materials are used effectively in both immature and mature teeth, contributing to the long-term success of vital pulp therapy.

Conditions

Reversible Pulpitis; Irreversible Pulpitis; Mature Teeth; Immature Teeth

Keywords

Vital pulp therapy; Pulpotomy; Dentin bridge formation; Periapical Index; Retrospective study

Outcome Measures

Primary Outcomes (2)

• Clinical Success of Pulpotomy in Mature and Immature Permanent Teeth

  Clinical success was determined based on the absence of symptoms such as spontaneous pain, tenderness to percussion, swelling, sinus tract formation, and abnormal mobility. Teeth exhibiting normal function without signs of pulpal or periapical pathology during follow-up examinations were classified as clinically successful. Additionally, patient-reported outcomes, including the resolution of preoperative symptoms and continued functionality, were considered in the clinical assessment.

  24 months

• Radiographic Success of Pulpotomy in Mature and Immature Permanent Teeth

  Radiographic success was defined by the absence of periapical radiolucency, internal or external root resorption, and signs of pathological changes in the periradicular tissues. Teeth demonstrating a well-preserved root structure, maintained pulp space dimensions, and no evidence of progressive pathology on follow-up radiographs were considered radiographically successful. Consistent findings across multiple follow-up intervals further confirmed the stability of pulpal and periapical health post-pulpotomy.

  24 months

Study Arms (1)

Pulpotomy

EXPERIMENTAL

In cases where pulp exposure exceeded 2 mm, the pulpotomy procedure was performed. The intervention commenced with the excision of the pulp chamber roof using a steel round bur. The coronal pulp tissue was then amputated at the level of the canal orifices utilizing a sterile sharp spoon excavator. Hemostasis was achieved by applying a sterile cotton pellet moistened with physiological saline for 3-5 minutes. Once hemostasis was confirmed, the cavity was further disinfected with 2.5% sodium hypochlorite. Subsequently, a 2 mm thick layer of mineral trioxide aggregate was placed over the pulp stump and covered with a resin-modified glass ionomer cement. To enhance adhesion, the cavity walls were conditioned with 35% orthophosphoric acid following the removal of residual material using a steel round bur. After the application of a dentin bonding agent, the definitive restoration was completed with composite resin using an incremental layering technique.

Procedure: Pulpotomy with Calcium Silicate-Based Bioceramics in Permanent Teeth

Interventions

Pulpotomy with Calcium Silicate-Based Bioceramics in Permanent Teeth PROCEDURE

This intervention involves performing pulpotomy using calcium silicate-based bioceramic materials, MTA and Biodentine™, in both mature and immature permanent teeth diagnosed with reversible or irreversible pulpitis. The study uniquely evaluates the long-term clinical and radiographic success of these materials by assessing pulp healing, dentin bridge formation, and periapical healing over a 24-month follow-up period. Additionally, this study compares clinical survival rates between mature and immature teeth, contributing to the growing body of evidence on the efficacy of pulpotomy in cases traditionally considered for root canal treatment. Unlike conventional pulpotomy studies, this research incorporates retrospective data analysis to align with international standards, addressing gaps in existing literature.

Pulpotomy

Eligibility Criteria

• Age: 7 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Mature and immature permanent teeth exposed to caries.
• Teeth with reversible or irreversible clinical symptoms.
• Periapical index (PAI) scores of 1 or 2 (indicating healthy or mildly inflamed periapical tissues) at baseline.
• Patients without any systemic disorders.

You may not qualify if:

• Radiographic evidence of periradicular or interradicular lesions.
• Presence of internal or external root resorption.
• Patients with systemic conditions that may compromise healing, such as diabetes or immunosuppression.

Sponsors & Collaborators

• Muhammed Alagöz: lead

Study Sites (1)

Ataturk University Faculty of Dentistry

Erzurum, 25200, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Pulpotomy

Intervention Hierarchy (Ancestors)

Endodontics; Dentistry

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: research assistant

Study Record Dates

• First Submitted: March 7, 2025
• First Posted: March 13, 2025
• Study Start: May 25, 2022
• Primary Completion: January 30, 2025
• Study Completion: March 3, 2025
• Last Updated: March 13, 2025

Record last verified: 2025-03

Locations

TU (1)