Indirect Pulp Capping With Biodentine and TheraCal LC in Permanent Mature Molars

NCT03741816 | Unknown DMC

• 1 other identifier: 1/2018
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 1

Brief Summary

Management of deep carious lesions in permanent mature molars with reversible pulpitis represents a challenge for clinicians. Vital pulp therapy includes indirect and direct pulp capping, partial pulpotomy and full pulpotomy. Indirect pulp capping is a procedure in which a material is placed on a thin layer of remaining soft dentin that, if removed, might expose the pulp. The objective is dentin bridge formation and pulp vitality preservation. The aim of this randomized clinical trial is to evaluate the success rate of indirect pulp capping with Biodentine and TheraCal LC in mature permanent molars with deep carious lesions at one-year follow-up examination. The null hypothesis tested will be that there is no statistically significant difference in success rate between both materials in indirect pulp capping of permanent mature molars with deep carious lesions.

Conditions

Deep Carious Lesions; Reversible Pulpitis; Indirect Pulp Capping

Keywords

permanent molars; indirect pulp capping; reversible pulpitis; deep carious lesions; Biodentine; TheraCal LC

Outcome Measures

Primary Outcomes (1)

• response to pulp sensibility testing ( thermal and electric pulp testing)

  abscence of clinical signs and/or symptoms and radiographic findings of pulp degeneration

  one year

Study Arms (2)

Biodentine

ACTIVE COMPARATOR

Indirect pulp capping with Biodentine in mature permanent molars with deep carious lesions and reversible pulpitis

Drug: Indirect pulp capping

TheraCal LC

EXPERIMENTAL

Indirect pulp capping with TheraCal LC in mature permanent molars with deep carious lesions and reversible pulpitis

Drug: Indirect pulp capping

Interventions

Indirect pulp capping DRUG

Indirect pulp capping is a procedure in which a material is placed on a thin partition of remaining carious dentin that, if removed might expose the pulp.

Biodentine; TheraCal LC

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient ≥ 18 years without any systemic disease.
• Presence of a deep carious lesion in a permanent mature molar without periapical pathology that penetrates radiographically into the inner dentin half or even third/ quarter.
• Preoperative diagnosis of reversible pulpitis.
• After selective caries removal to soft dentin with a high-speed diamond bur and Cariosolv gel and hand instruments, no pulpal exposure occurred.

You may not qualify if:

• Negative response to pulp sensibility tests.
• Clinical symptoms of irreversible pulpitis or pulp necrosis.
• Presence of fistula, swelling, tenderness to percussion, tooth mobility.
• Presence of periapical pathology on periapical radiographs (internal or external root resorption, abscence of normal appearance of periodontal ligament, presence of interradicular or periapical radiolucencies).
• Pregnant women.

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

University of Valencia

Valencia, Spain

RECRUITING

Central Study Contacts

Cristina Pasarín Linares

CONTACT

+ 34 630493515; cpasarinlinares@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching Assistant

Study Record Dates

• First Submitted: November 12, 2018
• First Posted: November 15, 2018
• Study Start: January 7, 2019
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2022
• Last Updated: January 8, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)