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Clinical Trials/NCT06874088
NCT06874088CompletedNot Applicable

Evaluation of Clinical and Radiographic Prognosis of Pulpotomy Treatment Performed on Teeth with Different Symptoms and Stages of Root Development: a Retrospective Study

Muhammed Alagöz1 site in 1 country34 target enrollmentStarted: May 25, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
34
Locations
1
Primary Endpoint
Clinical Success of Pulpotomy in Mature and Immature Permanent Teeth

Study Overview

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.

Detailed Description

This retrospective study evaluates the effectiveness of bioceramic materials such as Mineral Trioxide Aggregate (MTA) and Biodentine™ in the treatment of both reversible and irreversible pulpitis cases. The study compares the clinical survival rates of pulpotomy in teeth with mature and immature root structures and assesses long-term biological outcomes, including pulp healing, dentin bridge formation, and periapical healing. Additionally, the study aims to address gaps in the literature by providing retrospective data from our country and making it comparable with international standards.

Detailed Description

Study Objectives

To retrospectively analyze the effectiveness of bioceramic materials such as MTA and Biodentine™ in cases of reversible and irreversible pulpitis.

To compare the clinical survival rates of pulpotomy in teeth with mature and immature root structures.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
7 Years to 14 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •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.

Exclusion Criteria

  • •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.

Arms & Interventions

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.

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

Outcomes

Primary Outcomes

Clinical Success of Pulpotomy in Mature and Immature Permanent Teeth

Time Frame: 24 months

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.

Radiographic Success of Pulpotomy in Mature and Immature Permanent Teeth

Time Frame: 24 months

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Muhammed Alagöz
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Muhammed Alagöz

research assistant

Ataturk University

Study Sites (1)

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