Clinical trial NCT06874088: Clinical and Radiographic Outcomes of Pulpotomy in Teeth with Different Symptoms and Root Stages
Official title: Evaluation of Clinical and Radiographic Prognosis of Pulpotomy Treatment Performed on Teeth with Different Symptoms and Stages of Root Development: a Retrospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Reversible Pulpitis
Irreversible Pulpitis
Mature Teeth
Immature Teeth
Keywords: Vital pulp therapy
Pulpotomy
Dentin bridge formation
Periapical Index
Retrospective study
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2025-03-13
Enrollment: 34
Sex: ALL
Minimum age (years): 7
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

To evaluate long-term biological outcomes based on criteria such as pulp healing, dentin bridge formation, and periapical healing.

To provide retrospective data from our country that can be compared with international standards, addressing gaps in the existing literature.

Clinical Procedure

The treatment protocol was performed by a single pediatric dentist. After local anesthesia, rubber dam isolation was applied to enhance visibility and maintain asepsis. The enamel, dentin, and pulp chamber roof were sequentially removed using ISO 021-023 diamond and steel round burs (NTI-Kahla GmbH, Kahla, Germany). The coronal pulp tissue was amputated up to the root canal orifices using a sterile sharp steel round bur. Hemostasis was achieved by applying a sterile cotton pellet soaked in 2.5% sodium hypochlorite and saline solution.

Following hemostasis, the bioceramic materials were freshly mixed according to the manufacturer's recommendations. A 2-3 mm thick layer of either MTA (Biofactor, Imicryl Dental, Konya, Turkey) or Biodentine™ (Septodont, France) was carefully applied to the pulp chamber floor. The material was then covered with a resin-modified glass ionomer cement (Ionoseal, VOCO GmbH, Cuxhaven, Germany). Any excess material adhering to the cavity walls was removed using a steel round bur to ensure optimal adhesion of the restorative material and to prevent microleakage. The cavity walls were then etched with 35% orthophosphoric acid (Vococid, Voco, Germany), followed by the application of a dentin bonding agent (Futurabond-U, Voco, Germany). The final restoration was completed using a composite resin (Solare-X, GC, Tokyo, Japan) in a layering technique. Occlusal adjustments and polishing were performed in the same session.

Follow-up and Outcome Evaluation

Clinical and radiographic follow-up evaluations were conducted at an average of 24 months post-treatment. Clinical parameters such as spontaneous pain, nocturnal pain, vestibular swelling, pathological mobility, and percussion or palpation sensitivity were recorded before and after treatment to assess success.

Radiographic evaluations were performed using the Periapical Index (PAI) to assess periapical healing, and the presence of a dentin bridge was also examined in follow-up radiographs. Additionally, root development was assessed using the Moorrees Index in initial and follow-up radiographs.

This study provides valuable insight into the long-term effectiveness of pulpotomy in mature and immature teeth, contributing to the existing body of knowledge on vital pulp therapy.

Eligibility criteria: 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.

Primary outcomes:
measure: Clinical Success of Pulpotomy in Mature and Immature Permanent Teeth
timeFrame: 24 months
measure: Radiographic Success of Pulpotomy in Mature and Immature Permanent Teeth
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Ataturk University Faculty of Dentistry
Study officials:
References: