Direct Pulp Capping Compared to Partial Pulpotomy in Carious Pulp Exposures

NCT06495242 | Active Not Recruiting

• 1 other identifier: 131/2023
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This a prospective randomized clinical trial that compare vital pulp therapy procedures in permanent teeth with carious pulp exposure. Patients are recruited from the dental teaching clinics at JUST following preset inclusion criteria. They are subsequently randomly assigned to one of treatment procedures. Clinical and radiographic follow up is performed after 6 months and yearly up to 5 years.

Conditions

Deep Caries

Keywords

Caries, pulpitis, direct pulp capping, partial pulpotomy,, pain

Outcome Measures

Primary Outcomes (1)

• Short term clinical outcome

  Resolution of clinical symptoms

  one week

Secondary Outcomes (1)

• long term outcome

  1-5 years

Study Arms (2)

Direct pulp capping

ACTIVE COMPARATOR

After caries excavation and pulp exposure, the cavity is disinfected . the capping material is applied and the tooth is restored.

Procedure: Direct pulp capping and partial pulpotomy

Partial pulpotomy

ACTIVE COMPARATOR

After caries excavation and pulp exposure, 2-3 mm of the exposed pulp are cut . The capping material is applied and the tooth is restored.

Procedure: Direct pulp capping and partial pulpotomy

Interventions

Direct pulp capping and partial pulpotomy PROCEDURE

Two types of vital pulp therapy procedures

Also known as: Partial pulpotomy

Direct pulp capping; Partial pulpotomy

Eligibility Criteria

• Age: 12 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Non -contributory medical history (ASA 1)
• Molar tooth with extremely deep caries extending\>2/3 of dentin or exposing the pulp on the periapical radiograph
• The tooth should give positive response to cold testing
• Clinical diagnosis of reversible pulpitis with mild to moderate symptoms
• The tooth is restorable, probing pocket depth and mobility are within normal limits
• No signs of pulpal necrosis including sinus tract or swelling
• No radiographic evidence of periapical changes indicative of apical periodontitis

You may not qualify if:

• Immature teeth
• Nonvital teeth
• Irreversible pulpitis and periapical periodontitis, i.e spontaneous and lingering pain.
• Inability to achieve hemostasis after 6 minutes of application of 5% NaOCl moist pellet
• No pulp exposure after nonselective caries removal

Sponsors & Collaborators

• King Abdullah University Hospital: lead
• Jordan University of Science and Technology: collaborator

Study Sites (1)

Faculty of Dentistry, Jordan University of Science and Technology

Irbid, 3030, Jordan

Location

Related Publications (5)

• Taha NA, Albakri SW. Outcome and Prognostic Factors for Partial and Full Pulpotomy in the Management of Spontaneous Symptomatic Pulpitis in Carious Mature Permanent Teeth: A Randomized Clinical Trial. J Endod. 2024 Jul;50(7):889-898. doi: 10.1016/j.joen.2024.03.012. Epub 2024 Apr 5.

  PMID: 38583758 BACKGROUND

• Taha NA, Khazali MA. Partial Pulpotomy in Mature Permanent Teeth with Clinical Signs Indicative of Irreversible Pulpitis: A Randomized Clinical Trial. J Endod. 2017 Sep;43(9):1417-1421. doi: 10.1016/j.joen.2017.03.033. Epub 2017 Jun 30.

  PMID: 28673494 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

• 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

• Taha NA, Ahmad MB, Ghanim A. Assessment of Mineral Trioxide Aggregate pulpotomy in mature permanent teeth with carious exposures. Int Endod J. 2017 Feb;50(2):117-125. doi: 10.1111/iej.12605. Epub 2016 Jan 30.

  PMID: 26715408 BACKGROUND

MeSH Terms

Conditions

Pulpitis; Pain

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Prof Nessrin A Taha, PhD

  Jordan University of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: the participants are blinded to the type of treatment provided, the care provider is masked only during the early stages of teh procedure but subsequently masking is not possible due to different treatment protocols. Block randomization. and sealed envelop technique are used. Principal investigator and evaluator are blinded to the type of treatment provided
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Parallel randomized clinical trial including 2 treatment groups with 1;1 allocation ration

Study Record Dates

• First Submitted: July 2, 2024
• First Posted: July 10, 2024
• Study Start: March 25, 2023
• Primary Completion: December 28, 2024
• Study Completion (Estimated): December 2, 2026
• Last Updated: May 13, 2025

Record last verified: 2025-05

Locations

JO (1)