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

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ClinicalTrials.gov Identifier: NCT03741816
Recruitment Status : Recruiting
First Posted : November 15, 2018
Last Update Posted : January 8, 2019
Sponsor:
Information provided by (Responsible Party):
Cristina Pasarín Linares, University of Valencia

Tracking Information
First Submitted Date  ICMJE November 12, 2018
First Posted Date  ICMJE November 15, 2018
Last Update Posted Date January 8, 2019
Actual Study Start Date  ICMJE January 7, 2019
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 12, 2018)
response to pulp sensibility testing ( thermal and electric pulp testing) [ Time Frame: one year ]
abscence of clinical signs and/or symptoms and radiographic findings of pulp degeneration
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03741816 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Indirect Pulp Capping With Biodentine and TheraCal LC in Permanent Mature Molars
Official Title  ICMJE Randomized Blind Clinical Trial, Two-armed, Parallel of Indirect Pulp Capping With Biodentine and TheraCal LC in Permanent Mature Molars With Deep Carious Lesions
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.

Detailed Description

Treatment options for permanent mature molars with deep carious lesions and a preoperative diagnosis of reversible pulpitis are varied among clinicians. In the last few years, a more biological approach is arising interest in the field of Endodontics through the development of calcium-silicate based cements that are used in vital pulp therapy.

A great variety of materials have been employed for indirect pulp capping. Although calcium hydroxide has been the "gold standard" for decades for this procedure, nowadays calcium-silicate based cements such as Mineral Trioxide Aggregate (MTA) are preferred. The second generation of these cements, among which Biodentine (Septodont, Saint Maur-des-Fossés, France) and TheraCal LC (Bisco, Schaumburg, IL, USA) stand out, try to overcome the first generation limitations.

On the other hand, there is a paradigm shift in caries removal techniques. Nowadays, the non-selective technique is not longer recommended and a selective removal technique until soft dentin is preferred in deep cavitated lesions.

The study will be carried out at the dental clinic of the Master of Restorative Dentistry and Endodontics (Medical and Dental School) of University of Valencia (Spain).

The study protocol that will be followed is:

  1. Sample size estimation: 212 participants (106 per group).
  2. Informed written consent will be obtained from all participants.
  3. A full dental and medical history will be obtained from all patients.
  4. Clinical (thermal and electric pulp tests, and palpation and percussion) and a radiographic examination (periapical radiograph and a small-volume cone beam computed tomography (CBCT).
  5. Anesthesia administration and rubber dam placement.
  6. Selective caries removal technique with high-speed diamond burs with air/water spray for enamel and Cariosolv gel and hand instruments until soft dentin.
  7. Allocation to one of the two groups: Biodentine (control) or TheraCal LC (experimental) for indirect pulp capping procedures.
  8. Final direct composite restoration using the selective etching technique and an universal adhesive.
  9. Baseline periapical radiograph.
  10. Follow-up: clinical and radiographic follow-up examinations will be conducted at one month, six months and twelve months (±2 weeks). In the one-year follow-up examination, a small-volume CBCT will be taken.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Deep Carious Lesions
  • Reversible Pulpitis
  • Indirect Pulp Capping
Intervention  ICMJE Drug: Indirect pulp capping
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.
Study Arms  ICMJE
  • Active Comparator: Biodentine
    Indirect pulp capping with Biodentine in mature permanent molars with deep carious lesions and reversible pulpitis
    Intervention: Drug: Indirect pulp capping
  • Experimental: TheraCal LC
    Indirect pulp capping with TheraCal LC in mature permanent molars with deep carious lesions and reversible pulpitis
    Intervention: Drug: Indirect pulp capping
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 12, 2018)
212
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2022
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patient ≥ 18 years without any systemic disease.
  2. 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.
  3. Preoperative diagnosis of reversible pulpitis.
  4. After selective caries removal to soft dentin with a high-speed diamond bur and Cariosolv gel and hand instruments, no pulpal exposure occurred.

Exclusion Criteria:

  1. Negative response to pulp sensibility tests.
  2. Clinical symptoms of irreversible pulpitis or pulp necrosis.
  3. Presence of fistula, swelling, tenderness to percussion, tooth mobility.
  4. 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).
  5. Pregnant women.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Cristina Pasarín Linares + 34 630493515 cpasarinlinares@gmail.com
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03741816
Other Study ID Numbers  ICMJE 1/2018
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Cristina Pasarín Linares, University of Valencia
Study Sponsor  ICMJE University of Valencia
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Valencia
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP