Clinical trial NCT06575062: The Effect of Different Treatment Methods on the Apical Closure and Treatment Success in Permanent First Molars
Official title: The Effect of Different Treatment Methods on Apical Closure and Treatment Success in Immature Permanent First Molars with Reversible Pulpitis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Symptomatic Reversible Pulpitis (Disorder)
Keywords: Immature Permanent Molars
Pulpotomy
Direct Capping
Root Development
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2024-08-28
Enrollment: 60
Sex: ALL
Minimum age (years): 7
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this thesis study is to evaluate the clinical and radiographic success of direct capping and pulpotomy applications using ProRoot MTA (mineral trioxide aggregate) in lower permanent first molars with reversible pulpitis symptoms that have not yet completed their root development. Additionally, the study aims to assess the effects of these treatments on maturogenesis, specifically root development and apical closure.

Detailed description: The objective of this thesis is to investigate the effectiveness of direct capping and pulpotomy treatments using ProRoot MTA in managing reversible pulpitis in lower permanent first molars that have not yet achieved full root development. This study focuses on assessing both clinical and radiographic outcomes of these dental procedures. Specifically, it aims to determine the impact of these treatments on the natural progression of root formation and the closure of the root apex, a process known as maturogenesis. By examining these factors, the study seeks to provide a comprehensive understanding of how ProRoot MTA can be utilized to facilitate proper root development and healing in immature permanent molars affected by reversible pulpitis.

The study will test the following hypotheses:

Hypothesis 1: There is no difference between the clinical and radiographic success of direct capping and pulpotomy treatments in cases of reversible pulpal involvement of immature permanent molars.

Hypothesis 2: In cases of reversible pulpal involvement of immature permanent molars, direct capping and pulpotomy treatments have no effect on apexogenesis.

Hypothesis 3: Different root development levels of the teeth have no effect on the success of direct capping and pulpotomy treatments in cases of reversible pulpal involvement of immature permanent molars.

The main questions the study aims to answer are:

What are the clinical and radiographic outcomes at 3, 6, 12, and 18 months after treatment with direct capping and pulpotomy using ProRoot MTA.

How do these treatments affect root development and apical closure.

Participants in this study will:

Receive either direct capping or pulpotomy treatments using ProRoot MTA. Undergo clinical and radiographic evaluations at 3, 6, 12, and 18 months post-treatment.

Have their root development stages categorized according to the Moorrees classification (R½, R¾, Rc, A½) to assess the impact of treatments on maturogenesis.

The study aims to provide valuable insights into the effectiveness of ProRoot MTA in treating reversible pulpitis in immature permanent molars, contributing to improved clinical practices and patient outcomes.

Clinical Evaluation Criteria

Presence of spontaneous, long-lasting, or throbbing pain. Sensitivity to percussion and palpation. Presence of a fistula or swelling in the buccal or lingual region. Abnormal tooth mobility.

Radiological Evaluation Criteria

Widening of the periodontal space. Radiolucency in the interradicular or periradicular regions. Evidence of internal or external root resorption. Monitoring of root development stages according to the Moorrees classification. This study aims to provide valuable insights into the effectiveness of ProRoot MTA in treating reversible pulpitis in immature permanent molars, contributing to improved clinical practices and patient outcomes.

Eligibility criteria: Inclusion Criteria:

* Ages ranging from 7 to 10 years.
* Systemically healthy individuals.
* Have symptomatic reversible pulpitis characterized by pain that starts spontaneously and does not subside for a long time but does not include throbbing or night pain.
* Patients with permanent mandibular molars exhibiting open root tips, classified as Moorrees stages R½, R¾, Rc, or A½.

Exclusion Criteria:

* Children with systemic diseases.
* Presence of signs indicative of pulp necrosis, such as fistula or swelling in the buccal/lingual region.
* Tenderness upon palpation in the buccal/lingual region.
* Pain upon percussion.
* Presence of interradicular or periradicular radiolucency on radiographic examination.
* Evidence of internal or external root resorption.
* Widening of the periodontal space.
* Teeth with caries or molar-incisor hypomineralization (MIH) that result in excessive material loss potentially leading to restoration failure.
* Patients with inflammation and hyperemia in the root pulp.
* Permanent mandibular molar teeth with closed or nearly closed root ends, classified as Moorrees stage Ac.

Primary outcomes:
measure: Clinical success after pulpotomy or direct pulp capping treatment
timeFrame: 6 Month - 1 Year
measure: Radiographic assessment after pulpotomy or direct pulp capping treatment
timeFrame: 6 Month - 1 Year
Secondary outcomes:
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Ataturk University Faculty of Dentistry
Study officials:
affiliation: Ataturk University Faculty of Dentistry
name: sera derelioğlu, Prof. dr
role: PRINCIPAL_INVESTIGATOR
References: