Comparative Evaluation of Three Pulpotomy Agents for Permanent Mature Molars With Irreversible Pulpitis

NCT06232941 | Unknown

• 1 other identifier: FDASU-REC1261
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

Statement of the problem: Accurate pulpal diagnosis is essential for decision making between vital pulp therapy and root canal treatment. Clinical and radiographic examinations do not correctly reflect the histological state of the pulp and consequently its ability to heal. Also, despite the various advantages of using MTA as a pulp capping agent, it has several drawbacks. Aim of the study: The aim of the study is to compare two types of calcium silicate-based materials to MTA in permanent mature molars diagnosed with irreversible pulpitis regarding the following parameters; level of inflammatory biomarker level, clinical and radiographic outcomes. Materials and methods: Thirty-six patients with mature permanent molars exhibiting signs and symptoms indicative of irreversible pulpitis will be enrolled. A careful periodontal treatment and standardized operative procedure will be followed for all participants. Gingival crevicular fluid samples will be obtained before any local anesthetics' administration, followed by isolation of teeth with a dental dam and removal of caries. Pulpotomy will be performed using sterile round bur till level of orifices and then haemostasis will be achieved using sodium hypochlorite. At this point, patients will be randomly divided into three groups of 12 depending on the type of calcium silicate-based material used. Later, resin modified glass ionomer will be applied, etching, bonding and placement of composite as the permanent restoration. Follow up clinically and radiographically will be done.

Conditions

Vital Pulp Therapy

Outcome Measures

Primary Outcomes (1)

• Inflammatory marker level (matrix metalloproteinase 9) for assessment of pulpotomy success.

  Inflammation biomarker which is matrix metalloproteinase 9 (diagnostic) may be provided by molecules expressed during the cascade of tissue inflammation. Also, studies have demonstrated that the presence of protein markers or biomarkers in gingival crevicular fluid (GCF) can represent pulpal events

  Inflammatory biomarker level in gingival crevicular fluid using ELISA kit at the day of the procedure and then after 1 week .

Secondary Outcomes (1)

• Radiographic evaluation

  baseline, after 6 and 12 months

Study Arms (3)

Odontocem pulpotomy agent

EXPERIMENTAL

calcium silicate-based technology containing 0.2% of the low steroid triamcinolone acetonide and has outstanding biocompatibility, handling properties and least amount of staining potential

Procedure: Full pulpotomy procedure

NeoPutty bioceramic

ACTIVE COMPARATOR

premixed format of tricalcium silicate-based material (Bioceramic). It's composed of tantalum oxide, tricalcium silicate, calcium aluminate, dicalcium silicate, tricalcium aluminate, and calcium sulfate

Procedure: Full pulpotomy procedure

Mineral Trioxide Aggregate material

ACTIVE COMPARATOR

hydrophilic and biocompatible endodontic biomaterial, capable of stimulating healing and osteogenesis

Procedure: Full pulpotomy procedure

Interventions

Full pulpotomy procedure PROCEDURE

vital pulp therapy for molars with irreversible pulpitis instead of doing root canal treatment

Also known as: vital pulp therapy

Mineral Trioxide Aggregate material; NeoPutty bioceramic; Odontocem pulpotomy agent

Eligibility Criteria

• Age: 16 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Participants with permanent molars considered as having clinical signs and symptoms consistent with a diagnosis of irreversible pulpitis if they presented with the following chief complaint:
• Intermittent or spontaneous, sharp or dull, localized, diffuse, or referred pain.
• Rapid exposure to dramatic temperature changes elicited heightened and --prolonged episodes of pain even after the thermal stimulus has been removed.
• Participants without signs and symptoms of apical periodontitis
• Periodontally healthy permanent molars
• Systemically healthy patients without any history of long-acting NSAIDs intake in the past one week will be included to eliminate any confounding factors.

You may not qualify if:

• Non-restorable teeth with cracks or subgingival caries, associated sinus or swelling, immature roots, periapical rarefaction (PAI score ≥ 3).
• Poor periodontal support.
• Negative response to pulp sensibility tests.
• Diabetic, immune-compromised, pregnant patients
• Patient had a positive history of antibiotic use in the past 1 month or required antibiotic prophylaxis
• The tooth was previously accessed
• The tooth had an inflamed pulp in which bleeding could not be controlled within 10 minutes.

Sponsors & Collaborators

• Ain Shams University: lead

Central Study Contacts

Nourhan M Yehia, assistant lecturer

CONTACT

+2011146656546; nourhan.yehia@miuegypt.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2023
• First Posted: January 31, 2024
• Study Start: April 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: January 31, 2024

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share