Assessment of Pain and Treatment Success After VPT Versus RCT in Mature Permanent Mandibular Molars With SIP: A RCT

Not Applicable

Not yet recruiting

• Conditions: Symptomatic Irreversible Pulpitis
• Interventions: Procedure: Root canal treatment; Procedure: Vital pulp therapy

• Registration Number: NCT05681494
• Lead Sponsor: Cairo University

Brief Summary

Assessment of postoperative pain and treatment success after vital pulp therapy versus root canal treatment in mandibular molar with signs and symptoms of irreversible pulpitis. the null hypothesis, there is no difference will be observed in the pain level and treatment success between two treatments.

Detailed Description

After proper clinical and radiographic examination. Teeth will be anesthetized and isolated using a rubber dam. The operative field will be disinfected. Total caries removal will be done from outside making margin caries free to inside. the new diamond bur will be used to remove the last layer and exposed the pulp tissue. Exposed pulp will be inspected under a dental operating microscope and hemostasis will be obtained. The teeth will be randomized into 2 intervention groups (VPT or RCT). Treatment will be finalized, and teeth will be restored with resin-modified glass ionomer followed by composite resin at the same appointment. Ibuprofen 400mg will be prescribed to the patient if needed. Patients will be asked to record postoperative pain after treatment on the pain score sheet.

Study Timeline

• Study First Submitted: 2022-12-28
• Study First Submitted QC: 2022-12-28
• Study First Posted: 2023-01-12
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-15
• Last Update Posted: 2023-02-16
• Study Start: 2023-02-26
• Primary Completion: 2023-07-26
• Study Completion: 2024-06-26

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• Systemically healthy patients.
• Patient's age range more than 15 years.
• Mature permanent mandibular molars with deep caries.
• Clinical diagnosis of symptomatic irreversible pulpitis.
• Teeth with no need for the post.
• Healthy periodontium and mobility within normal limits.
• Patients who can understand the pain scale and can sign the informed consent

Exclusion Criteria

• Teeth with a negative response to vitality testing.
• Teeth with furcal bone loss.
• Teeth with sinus tract
• Teeth with swelling.
• Teeth with a non-restorable crown.
• Teeth with immature roots.
• Teeth with no pulp exposure even after caries excavation.
• History of analgesic intake in the previous week.
• History of antibiotic intake in the previous month.
• Insufficient bleeding after pulp exposure suggestive of partial necrosis of the pulp.
• Inability to control bleeding within 10 min.
• Radiographic evidence of external or internal root resorption vertical root fracture, perforation, calcification.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Root canal treatment	Root canal treatment	after access cavity preparation, the working length will be determined. chemo-mechanical preparation will be done, and teeth will be obturated. final restoration will be placed.
Vital pulp therapy	Vital pulp therapy	exposed pulp will be capped with 3 mm calcium silicate material

Primary Outcome Measures

Name	Time	Method
Postoperative pain	at 6 hours postoperative	postoperative pain will be recorded by patient using NRS

Secondary Outcome Measures

Name	Time	Method
Intensity of postoperative pain	at 24, 48 hours and 7 days	postoperative pain will be recorded by patient using NRS
Treatment success	at 3,6,12 months	clinical and radiographic success