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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

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.


Condition or disease Intervention/treatment Phase
Deep Carious Lesions Reversible Pulpitis Indirect Pulp Capping Drug: Indirect pulp capping Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 212 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Blind Clinical Trial, Two-armed, Parallel of Indirect Pulp Capping With Biodentine and TheraCal LC in Permanent Mature Molars With Deep Carious Lesions
Actual Study Start Date : January 7, 2019
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Decay

Arm Intervention/treatment
Active Comparator: Biodentine
Indirect pulp capping with Biodentine in mature permanent molars with deep carious lesions and reversible pulpitis
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.

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




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03741816


Contacts
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Contact: Cristina Pasarín Linares + 34 630493515 cpasarinlinares@gmail.com

Locations
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Spain
University of Valencia Recruiting
Valencia, Spain
Sponsors and Collaborators
University of Valencia

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Responsible Party: Cristina Pasarín Linares, Teaching Assistant, University of Valencia
ClinicalTrials.gov Identifier: NCT03741816     History of Changes
Other Study ID Numbers: 1/2018
First Posted: November 15, 2018    Key Record Dates
Last Update Posted: January 8, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cristina Pasarín Linares, University of Valencia:
permanent molars
indirect pulp capping
reversible pulpitis
deep carious lesions
Biodentine
TheraCal LC
Additional relevant MeSH terms:
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Pulpitis
Dental Caries
Dental Pulp Diseases
Tooth Diseases
Stomatognathic Diseases
Tooth Demineralization