The Effect of Different Treatment Methods on the Apical Closure and Treatment Success in Permanent First Molars

NCT ID: NCT06575062

Last Updated: 2025-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-05
• Study Completion Date: 2025-06-05

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.

Conditions

Symptomatic Reversible Pulpitis (Disorder)

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Direct Capping

The direct capping technique was applied when the pulp exposure was less than 2 mm. In this application, cavity disinfection was achieved with a 2.5% sodium hypochlorite solution due to the exposed pulp. After controlling the bleeding, the MTA was prepared according to the manufacturer's recommendations and placed on the exposed area. The MTA was then covered with resin-modified glass ionomer cement. To ensure proper bonding of the restorative material and a leak-proof restoration, material residues on the cavity walls were removed with a steel round bur. The cavity walls were roughened with 35% orthophosphoric acid. Following the application of a dentin bonding agent, the upper restoration was completed with composite resin using the layering technique.

Group Type: ACTIVE_COMPARATOR

Direct Pulp Capping with ProRoot MTA

Intervention Type: PROCEDURE

In this intervention, following the removal of carious dentin, the pulp tissue is directly exposed. ProRoot MTA is carefully applied over the exposed pulp to create a protective barrier. The material is mixed according to the manufacturer's instructions and placed directly onto the pulp exposure site. A light pressure is applied to ensure a good adaptation of the material. MTA was covered with resin-modified glass ionomer cement. Restoration was completed using composite resin.

Pulpotomy

In cases where the pulp exposure was more than 2 mm, the pulpotomy technique was employed. The procedure began with the removal of the pulp roof using steel round burs. The pulp was then amputated up to the pulp canal openings with a sterile sharp spoon excavator. Hemostasis was achieved using a sterile cotton pellet impregnated with physiological saline for 3-5 minutes. If hemostasis could not be achieved and inflammation had progressed to the root pulp, regenerative endodontics was applied. Once hemostasis was secured, the cavity was disinfected again with 2.5% sodium hypochlorite. A 2 mm thick layer of MTA was applied to the pulp base and covered with MTA resin-modified glass ionomer cement. The cavity walls were roughened with 35% orthophosphoric acid after removing material residues with a steel round bur. Following the application of a dentin bonding agent, the upper restoration was completed with composite resin using the layering technique.

Group Type: ACTIVE_COMPARATOR

Pulpotomy with ProRoot MTA

Intervention Type: PROCEDURE

In this procedure, after the removal of the coronal pulp tissue, ProRoot MTA is applied over the exposed root canal orifices. The MTA is mixed according to the manufacturer's instructions and placed in the pulp chamber to cover the root canal entrances. The material is carefully adapted to create a seal that prevents bacterial contamination and promotes tissue healing. MTA was covered with resin-modified glass ionomer cement. Restoration was completed using composite resin.

Interventions

Direct Pulp Capping with ProRoot MTA

In this intervention, following the removal of carious dentin, the pulp tissue is directly exposed. ProRoot MTA is carefully applied over the exposed pulp to create a protective barrier. The material is mixed according to the manufacturer's instructions and placed directly onto the pulp exposure site. A light pressure is applied to ensure a good adaptation of the material. MTA was covered with resin-modified glass ionomer cement. Restoration was completed using composite resin.

Intervention Type: PROCEDURE

Pulpotomy with ProRoot MTA

In this procedure, after the removal of the coronal pulp tissue, ProRoot MTA is applied over the exposed root canal orifices. The MTA is mixed according to the manufacturer's instructions and placed in the pulp chamber to cover the root canal entrances. The material is carefully adapted to create a seal that prevents bacterial contamination and promotes tissue healing. MTA was covered with resin-modified glass ionomer cement. Restoration was completed using composite resin.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ataturk University

OTHER

Sponsor Role: lead

Responsible Party

Muhammed Alagöz

research assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

sera derelioğlu, Prof. dr

Role: PRINCIPAL_INVESTIGATOR

Ataturk University

Locations

Ataturk University Faculty of Dentistry

Erzurum, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Alagoz M, Derelioglu SS. The effect of different treatment methods on apical closure and treatment success in immature permanent first molars with reversible pulpitis. BMC Oral Health. 2025 Oct 8;25(1):1556. doi: 10.1186/s12903-025-06975-3.

Reference Type: DERIVED

PMID: 41063117 (View on PubMed)

Other Identifiers

B.30.2.ATA.0.01.00/360

Identifier Type: -

Identifier Source: org_study_id