Evaluation of the Success Rate of Pulpotomy Versus to Root Canal Therapy in Management of Mature First Permanent Molars With Irreversible Pulpitis

NCT ID: NCT07046533

Last Updated: 2025-07-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2026-07-01

Brief Summary

The goal of This current study compare the clinical & radiographic success rate between two different modalities conventional RCT and VPT using Bio-C-Repair as a pulp capping material to treat young patients with mature first permanent molars with irreversible pulpitis.

Detailed Description

The teeth were anesthetized with 4% articaine with adrenaline 1/100,000 , isolated under rubber dam , and sterilized using a cotton pellet soaked in 2.5% sodium hypochlorite (NaOCl). Then carious leisons were removed by using a fresh sterile high-speed diamond bur under copious water irrigation. Upon pulp exposed, the cavity was rinsed with 2.5% NaOCl. The other steps of the treatment proceeded accordingly:

The procedure FP involved the removal of all coronal pulp tissue to the canals orifices level through a fresh sterile high-speed diamond bur Hemostasis was accomplished by compressing a cotton pellet soaked in 2.5% NaOCl over the radicular pulp tissue for 5 min. Then, irrigation with amount of sterile 0.9% sodium chloride (NaCl) solution was gently conducted. Once hemostasis was achieved, the radicular pulp tissue was observed as uniformly reddish pink color. Subsequently, a new type of premixed pulp-capping bio c repair ) was prepared according to the manufacturer's instructions, and a 4-mm layer was directly adapted over the radicular pulp tissue, ensuring that there was not any excess materials on the pulp chamber walls. The access cavity was restored with a liner)and composite restoration all completed in a single visit. Then postoperative radiographs were taken.

RCT was conducted in single visit the pulp tissues were removed from all the root canals, identifying and enlarging canal orifices via fanta Gold rotary , determing the working length with an apex locator. The root canals preparation was conducted by rotary nickel-titanium files, irrigated by using 2.5% NaOCl and 17% ethylenediaminetetraacetic acid (EDTA), and disinfected by using Ca(OH)2.

obturation was performed with gutta-percha and biocermaic sealer, using single cone technique.The access cavity was restored with a liner and resin composite restoration during the same appointment while using rubber dam isolation.

Conditions

Irreversible Pulpitis (Toothache); Dental Caries (Diagnosis)

Study Design

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

Study Groups

root canal treatment

invasive technique depends on removal of all pulp tissue coronal and radicular and restore it with a gutta perch with bioceramic sealer

Group Type: ACTIVE_COMPARATOR

(pulpotomy)

Intervention Type: PROCEDURE

non invasive technique depends on remove only the coronal pulp tissue instead of remove all pulp tissue

root canal treatment

Intervention Type: PROCEDURE

invasive technique depends on remove all radicular and coronal pulp tissue

pulpotomy

non invasive technique depends on removal of only coronal pulp tissue and restore it with a new material bio c repair

Group Type: EXPERIMENTAL

(pulpotomy)

Intervention Type: PROCEDURE

non invasive technique depends on remove only the coronal pulp tissue instead of remove all pulp tissue

root canal treatment

Intervention Type: PROCEDURE

invasive technique depends on remove all radicular and coronal pulp tissue

Interventions

(pulpotomy)

non invasive technique depends on remove only the coronal pulp tissue instead of remove all pulp tissue

Intervention Type: PROCEDURE

root canal treatment

invasive technique depends on remove all radicular and coronal pulp tissue

Intervention Type: PROCEDURE

Other Intervention Names

vital pulp therapy

Eligibility Criteria

Inclusion Criteria

1. Molars teeth with a history of spontaneous radiating pain indicated IP

2. the pain triggered by hot/cold fluids lasted for several minutes after removing of the stimulus.

3. Molars teeth with no prominent radiolucency at the periapical or furcation regions

Exclusion Criteria

1. Teeth with continuous bleeding

2. necrosis

3. Teeth could not be restored with direct restoration. Teeth having localized/generalized periodontal diseases (probing pocket depth more than 3 mm).

Teeth with crack fracture. Teeth with internal/external root resorption. Teeth with pulp chamber/canal calcification

• Minimum Eligible Age: 9 Months
• Maximum Eligible Age: 14 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lamiaa Saeed Ahmed Elshiekh

OTHER

Sponsor Role: lead

Responsible Party

Lamiaa Saeed Ahmed Elshiekh

Assistant Lecturer of Pediatric Dentistry, Faculty of Dentistry October 6th University

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

Cairo2007

Identifier Type: -

Identifier Source: org_study_id