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

Sponsor
Cairo University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05681494
Collaborator
(none)
44
Enrollment
2
Arms
17
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Root canal treatment
  • Procedure: Vital pulp therapy
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
44 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Assessment of Postoperative Pain and Treatment Success After Vital Pulp Therapy Versus Root Canal Treatment in Mature Permanent Mandibular Molars With Irreversible Pulpitis: A Randomized Controlled Tria
Anticipated Study Start Date :
Jan 26, 2023
Anticipated Primary Completion Date :
Jul 26, 2023
Anticipated Study Completion Date :
Jun 26, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 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.

Procedure: 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.
Other Names:
  • RCT, Full pulpectomy

    		•
    Experimental: Vital pulp therapy

    exposed pulp will be capped with 3 mm calcium silicate material

    Procedure: Vital pulp therapy
    exposed pulp will be capped with 3 mm calcium silicate material
    Other Names:
  • pulpotomy

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Postoperative pain [at 6 hours postoperative]

      postoperative pain will be recorded by patient using NRS

    Secondary Outcome Measures

    1. Intensity of postoperative pain [at 24, 48 hours and 7 days]

      postoperative pain will be recorded by patient using NRS

    2. Treatment success [at 3,6,12 months]

      clinical and radiographic success

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    15 Years to 40 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Cairo University

    Investigators

    • Study Director: Ahmed S Elsheshtawy, Lecturer, Department of Endodontics, Faculty of Dentistry, Cairo university.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Amany Ibrahiem Ahmed Mohamed, Ph.D. degree candidate, Department of Endodontics, Faculty of Dentistry, Cairo university., Cairo University
    ClinicalTrials.gov Identifier:
    NCT05681494
    Other Study ID Numbers:
    • 28/12/2022
    First Posted:
    Jan 12, 2023
    Last Update Posted:
    Jan 12, 2023
    Last Verified:
    Dec 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Amany Ibrahiem Ahmed Mohamed, Ph.D. degree candidate, Department of Endodontics, Faculty of Dentistry, Cairo university., Cairo University
    SIP
    Additional relevant MeSH terms:
    Pulpitis

    Study Results

    No Results Posted as of Jan 12, 2023