Full Pulpotomy Procedure of Permanent Molar Teeth of Adults Using Calcium Silicate-based Sealer Material

Al-Azhar University

Status: Not yet enrolling

Conditions: Irreversible Pulpitis

Treatments: Procedure: Calcium silicate-based premixed putty full Pulpotomy; Procedure: Calcium silicate-based sealer full Pulpotomy; Procedure: Full Pulpotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT06504108

959/1498

Details and patient eligibility

About

This clinical study aims to assess the efficacy of using calcium silicate based sealer as a capping material after complete removal of coronal pulp tissue. The study will evaluate both the clinical and radiographic changes.

Full description

Root canal treatment has always been considered the first line of treatment for carious teeth with symptomatic irreversible pulpitis for a long time. However, after the evolution of calcium silicate based materials a more conservative option, which is pulpotomy began to gain reliability, especially that it preserves the vitality of the radicular pulp, clinically simpler, less time-consuming, and more cost-effective compared to conventional root canal treatment.

In this study the investigators assess the clinical and radiographic success rate of using calcium silicate based sealer as a pulp capping material in permanent molars after pulpotomy.

For the best of the investigators' knowledge, there is no available clinical data on the use of calcium-silicate based sealers as a pulp capping material in pulpotomy of permanent molars with symptoms of irreversible pulpitis.

Enrollment: 78 estimated patients

Sex: All

Ages: 20 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Vital mandibular molar teeth with mature apices.
• Teeth that respond positively to cold testing.
• Teeth without any signs of necrosis including sinus tract or swelling.
• Teeth with caries extending ≥ 2/3 of dentine or exposing the pulp.
• Teeth with symptomatic irreversible pulpitis with/without apical periodontitis.
• Teeth without periodontal diseases or mobility.
• Teeth without root resorption, detectable pulp chamber and root canal calcification or history of trauma.
• Patients from both genders with age range from 20 to 45 years old.
• Patients with good or moderate oral hygiene and without any systemic diseases.

Exclusion criteria

Pre-operative criteria:

• Non-vital teeth.
• Teeth with irreversible pulpitis with apical periodontitis.
• Teeth with immature apices.
• Teeth with Periodontal disease or mobility grade II or III.
• Teeth that are badly decayed and need post and core placement.
• Patients refused to continue treatment procedures or refuse to commit to periodic follow-up sessions.
• Non-restorable teeth.

Intra-operative criteria:

• If hemostasis could not be achieved within 6 minutes after full pulpotomy.
• Teeth with partial necrosis.
• No bleeding after access cavity preparation.

Post-operative criteria:

• presence of Swelling.
• presence of Sinus tract.
• Pain on percussion after the end of the first week.
• Pain with palpation.
• Pain on biting after the end of first week.
• Mobility of the tooth.
• Fracture of tooth structure that renders the tooth non-restorable.
• Fracture of the restoration during the evaluation.
• Probing depth more than 3 mm.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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78 participants in 3 patient groups

calcium silicate-based sealer

Experimental group

Description:

Performing full pulpotomy of permanent mandibular and maxillary molar teeth using calcium silicate-based sealer as a capping agent.

Treatment:

Procedure: Calcium silicate-based sealer full Pulpotomy

Premixed calcium silicate-based putty

Active Comparator group

Description:

Performing full pulpotomy of permanent mandibular and maxillary molar teeth using premixed calcium silicate-based putty as a capping agent.

Treatment:

Procedure: Calcium silicate-based premixed putty full Pulpotomy

combination between calcium silicate-based sealer and premixed calcium silicate-based putty

Experimental group

Description:

Performing full pulpotomy of permanent mandibular and maxillary molar teeth using a combination of calcium silicate-based sealer and premixed calcium silicate-based putty as a capping agent.

Treatment:

Procedure: Full Pulpotomy