Management of Deep Carious Lesions in Adults

NCT05144711 | Unknown

• 1 other identifier: 528/2021
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Dental caries is one of the most prevalent non-communicable disease. However, despite its prevalence there is no consensus on how much caries to remove prior to placing a restoration to achieve optimal outcomes. Evidence for selective compared to complete nonselective excavation suggests there may be benefit for selective removal in sustaining tooth vitality while histological studies reveal that the remaining dentine is actually infected and may cause loss of vitality in long term. The aim of this study is to randomly compare selective to non-elective excavation methods in carious mature permanent teeth with symptoms of reversible pulpitis

Conditions

Caries; Reversible Pulpitis

Keywords

Deep caries; Reversible pulpitis; Selective excavation; Nonselective excavation; Biodentine

Outcome Measures

Primary Outcomes (1)

• Absence of clinical symptoms

  Relief of pain after the procedure

  48 hours

Secondary Outcomes (1)

• Pulp vitality

  6, 12, 24, 48 months

Study Arms (2)

Selective excavation

ACTIVE COMPARATOR

Cries will be removed from the peripheries of the cavity, while only soft caries will be removed from the plural side leaving stained leathery dentine that can not be removed by hand instruments. Biodentine will be placed and the cavity will be restored.

Procedure: Selective caries excavation

Non selective excavation

ACTIVE COMPARATOR

Caries will be cleaned form all cavity peripheries and floor. Biodentine will be placed and the toothy will be restored.

Procedure: Non selective caries excavation

Interventions

Selective caries excavation PROCEDURE

Selective caries excavation leaving stained but leathery dentine towards the pulp

Selective excavation

Non selective caries excavation PROCEDURE

Complete excavation of caries regardless of the risk of pulp exposure

Non selective excavation

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• The patient age (16-60) years old
• Non -contributory medical history
• Deep caries extending\>= 2/3 of dentine but not exposing the pulp on the radiograph
• The tooth should give positive response to cold testing
• Clinical diagnosis of reversible pulpitis
• 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 roots
• caries exposing the pulp on radiograph
• symptoms of irreversible pulpits
• In ability to control bleeding after pulp exposure

Sponsors & Collaborators

• Jordan University of Science and Technology: lead

Study Sites (1)

Jordan University of science and technology

Irbid, 21110, Jordan

RECRUITING

Related Publications (2)

• Taha NA, About I, Sedgley CM, Messer HH. Conservative Management of Mature Permanent Teeth with Carious Pulp Exposure. J Endod. 2020 Sep;46(9S):S33-S41. doi: 10.1016/j.joen.2020.06.025.

  PMID: 32950193 RESULT

• Taha NA, Ali MM, Abidin IZ, Khader YS. Pulp survival and postoperative treatment needs following selective vs. total caries removal in mature permanent teeth with reversible pulpitis: A randomized clinical trial. J Dent. 2024 Dec;151:105408. doi: 10.1016/j.jdent.2024.105408. Epub 2024 Oct 22.

  PMID: 39442480 DERIVED

Study Officials

• Nessrin Taha, PhD

  Jordan University of Science and Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nessrin Taha, PhD

CONTACT

962776566110; n.taha@just.edu.jo

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: An informed consent will be obtained from the participant but he will not be informed whether selective or non selective excavation was done for him. the outcome assessor will be blinded to the procedure, and if required masking of the crowns of teeth on radiographs will be done before evaluation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cases randomly assigned into the two groups using a block method

Study Record Dates

• First Submitted: November 22, 2021
• First Posted: December 3, 2021
• Study Start: October 3, 2021
• Primary Completion: October 20, 2022
• Study Completion: June 1, 2024
• Last Updated: September 13, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)