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

NCT06575062 | Completed

• 1 other identifier: B.30.2.ATA.0.01.00/360
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Symptomatic Reversible Pulpitis (Disorder)

Keywords

Immature Permanent Molars; Pulpotomy; Direct Capping; Root Development

Outcome Measures

Primary Outcomes (2)

• Clinical success after pulpotomy or direct pulp capping treatment

  This outcome measure evaluates the absence of pathological signs or symptoms in the treated tooth, including no abscess formation, no swelling, no fistula development, no abnormal mobility, and no post-operative pain. Additionally, the absence of pain on palpation or percussion of the tooth is assessed.

  6 Month - 1 Year- 18 month

• Radiographic assessment after pulpotomy or direct pulp capping treatment

  This outcome measure involves the radiographic evaluation of the treated tooth post-pulpotomy or direct pulp capping. The assessment focuses on the absence of root resorption (both internal and external), no furcation involvement, no periapical radiolucency, and no loss of lamina dura. Additionally, a normal appearance of the periodontal ligament space is expected. The natural progression of root formation and root apex closure, known as maturogenesis, will be monitored according to Moorrees classification (stages R½, R¾, Rc, A½, and Ac), ensuring the process follows this sequence.

  6 Month - 1 Year - 18 month

Study Arms (2)

Direct Capping

ACTIVE COMPARATOR

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.

Procedure: Direct Pulp Capping with ProRoot MTA

Pulpotomy

ACTIVE COMPARATOR

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.

Procedure: Pulpotomy with ProRoot MTA

Interventions

Direct Pulp Capping with ProRoot MTA 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.

Direct Capping

Pulpotomy with ProRoot MTA 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.

Pulpotomy

Eligibility Criteria

• Age: 7 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Ataturk University Faculty of Dentistry

Erzurum, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 41063117 DERIVED

MeSH Terms

Interventions

ProRoot MTA; Pulpotomy

Intervention Hierarchy (Ancestors)

Endodontics; Dentistry

Study Officials

• sera derelioğlu, Prof. dr

  Ataturk University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: research assistant

Study Record Dates

• First Submitted: August 11, 2024
• First Posted: August 28, 2024
• Study Start: June 5, 2023
• Primary Completion: December 13, 2023
• Study Completion: June 5, 2025
• Last Updated: July 2, 2025

Record last verified: 2024-08

Locations

TU (1)