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

NCT05681494 | Unknown

• 1 other identifier: 28/12/2022
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Symptomatic Irreversible Pulpitis

Keywords

SIP

Outcome Measures

Primary Outcomes (1)

• Postoperative pain

  postoperative pain will be recorded by patient using NRS

  at 6 hours postoperative

Secondary Outcomes (2)

• Intensity of postoperative pain

  at 24, 48 hours and 7 days

• Treatment success

  at 3,6,12 months

Study Arms (2)

Root canal treatment

ACTIVE COMPARATOR

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

Vital pulp therapy

EXPERIMENTAL

exposed pulp will be capped with 3 mm calcium silicate material

Procedure: Vital pulp therapy

Interventions

Root canal treatment PROCEDURE

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.

Also known as: RCT, Full pulpectomy

Root canal treatment

Vital pulp therapy PROCEDURE

exposed pulp will be capped with 3 mm calcium silicate material

Also known as: pulpotomy

Vital pulp therapy

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Related Publications (4)

• Taha NA, Al-Rawash MH, Imran ZA. Outcome of full pulpotomy in mature permanent molars using 3 calcium silicate-based materials: A parallel, double blind, randomized controlled trial. Int Endod J. 2022 May;55(5):416-429. doi: 10.1111/iej.13707. Epub 2022 Mar 17.

  PMID: 35152464 BACKGROUND

• Santos JM, Pereira JF, Marques A, Sequeira DB, Friedman S. Vital Pulp Therapy in Permanent Mature Posterior Teeth with Symptomatic Irreversible Pulpitis: A Systematic Review of Treatment Outcomes. Medicina (Kaunas). 2021 Jun 3;57(6):573. doi: 10.3390/medicina57060573.

  PMID: 34205149 BACKGROUND

• Taha NA, Al-Khatib H. 4-Year Follow-up of Full Pulpotomy in Symptomatic Mature Permanent Teeth with Carious Pulp Exposure Using a Stainproof Calcium Silicate-based Material. J Endod. 2022 Jan;48(1):87-95. doi: 10.1016/j.joen.2021.09.008. Epub 2021 Sep 24.

  PMID: 34563506 BACKGROUND

• Asgary S, Eghbal MJ, Shahravan A, Saberi E, Baghban AA, Parhizkar A. Outcomes of root canal therapy or full pulpotomy using two endodontic biomaterials in mature permanent teeth: a randomized controlled trial. Clin Oral Investig. 2022 Mar;26(3):3287-3297. doi: 10.1007/s00784-021-04310-y. Epub 2021 Dec 2.

  PMID: 34854987 BACKGROUND

MeSH Terms

Interventions

Pulpotomy

Intervention Hierarchy (Ancestors)

Endodontics; Dentistry

Study Officials

• Ahmed S Elsheshtawy

  Lecturer, Department of Endodontics, Faculty of Dentistry, Cairo university.

  STUDY DIRECTOR

Central Study Contacts

Amany IA mohamed, phd

CONTACT

01099300346; amany.ahmed@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D. degree candidate, Department of Endodontics, Faculty of Dentistry, Cairo university.

Study Record Dates

• First Submitted: December 28, 2022
• First Posted: January 12, 2023
• Study Start: February 26, 2023
• Primary Completion: July 26, 2023
• Study Completion: June 26, 2024
• Last Updated: February 16, 2023

Record last verified: 2023-02