Clinical and Radiographic Evaluation of Pulpotomies in Primary Molars Using Tricalcium Silicate Cements

Clinical and Radiographic Evaluation of Pulpotomies in Primary Molars Using Tricalcium Silicate Cements.

The objective of the study is to evaluate the success rate of pulpotomies in temporary molars using different types of hemostats and pulp coating materials based on tricalcium silicates, in patients who have attended the Dental Clinic of the International University of Catalonia (UIC).

Study Overview

• Status: Recruiting
• Conditions: Primary Molar Pulpotomy
• Intervention / Treatment: Other: MTA HP Repair; Other: MTA Pro Root; Other: Biodentine

Detailed Description

This prospective randomized clinical trial study has been approved by the

Scientific Committee in January of 2017 and by Ethics Committee (END-ECL- 2017-01) . It will be conducted in patients needing a vital pulp

therapy treatment at the Pediatric Dentistry Department of Universitat Internacional de Catalunya (Sant Cugat del Vallés, Barcelona, Spain). The necessary statistical sample size assuming an alpha risk of 0.05, a beta risk of 0.05 and a power of 95% sample, the required sample obtained by group resulted in 52. Given an estimate upwards of 20% of drop-outs in controls, the final size results in 62.4 (63 cases per group).

The data collection will be recollected using Excel program. Statgraphics Centurion XV software (StatPoint Technologies, Inc., Warrenton, VA, USA) will be used for statistical analysis. The chi-square test will be used and logistic regression analysis of the results will be performed to assess differences between groups with a significance level of P <0.05.

• Study Type: Interventional
• Enrollment (Estimated): 61
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Francisco Guinot Jimeno, DDS, MsC; Phone Number: 0034 93 504 50 00; Email: fguinot79@hotmail.com
• Study Contact Backup: Name: ANA VELOSO DURAN, DDS, MsC; Phone Number: 0034 93 504 50 00; Email: ana_veloso13@hotmail.com

Study Locations

• Spain
  • Barcelona
    • Sant Cugat del Valles, Barcelona, Spain, 08195
      • Recruiting
      • Universitat Internacional de Catalunya
      • Sub-Investigator: ANA VELOSO DURAN, DDS, MsC
      • Contact: Francisco Guinot Jimeno, DDS, MsC; Phone Number: 0034 93 5045000; Email: fguinot79@hotmail.com
      • Principal Investigator: Francisco Guinot Jimeno, DDS, MsC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 9 years (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Responsible patients or parents or guardians who demonstrate that they understand the study and are willing to participate, as evidenced by signing the voluntary informed consent and receiving a signed and dated copy of the informed consent form.
• Children under 18 years of age with informed parental consent, correctly understood.
• Patient understands and is willing to comply with all study procedures and restrictions.
• Absence of clinical and radiographic evidence of pulp degeneration such as excessive bleeding, internal and / or external root resorption, destruction of the furcation.
• Asymptomatic and vital primary molars whose pulp exposure occurred during caries removal.

Exclusion Criteria:

• Patients with systemic pathologies (diabetes, inmunosuppresed or any clinically significant or relevant oral abnormality).
• Previous history of allergic reaction to local anesthesics or to the different constituents of the pulp agents to be studied.
• Pulp diagnosis of irreversible pulpits or pulp necrosis, root resorption, root fractures, pathological mobility, spontaneous pain, impossibility of restoration, and if pulpotomy is not the treatment of choice.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pulp Dressing MTA Angelus; pulp therapy	Other: MTA HP Repair; pulp therapy
Experimental: Pulp Dressing MTA Pro Root; pulp therapy	Other: MTA Pro Root; pulp therapy
Experimental: Pulp Dressing Biodentine; pulp therapy	Other: Biodentine; pulp therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
visual examination	Clinical examination.Data will be recorded in terms of clinical signs of success.Clinical failure was determined by the subjective symptoms as explained by the participants and objective signs as recorded during clinical examination.	12 months
Radiographic Success	RX examination,Radiographic evaluation if success was performed according evidence of perirradicular or furcation pathosis or pathology root resorption.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radicular Radiolucency	RX examination,Radiographic evaluation if success was performed according evidence of perirradicular or furcation pathosis.	12 months
Internal Resorption	RX examination,Radiographic evaluation if success was performed according evidence of pathology root resorption.	12 months
External Resorption	RX examination,Radiographic evaluation if success was performed according evidence of pathology root resorption.	12 months
Furcation Radiolucency	RX examination,Radiographic evaluation if success was performed according evidence of perirradicular or furcation pathosis.	12 months
Symptoms of pain	Clinical examination,The patient will be recalled for control . Data will be recorded in terms of presence of symptoms, clinical and radiographic signs of success / failure, vertical and lateral percussion, periodontal probing and periapical and bitewing be implemented following the same methodology as in the initial evaluation.Clinical failure was determined by the subjective symptoms as explained by the participants.	12 months
Swelling	Clinical examination . Clinical failure was determined by the subjective symptoms as explained by the participants and objective signs as recorded during clinical examination including swelling.	12 months
Fistulation	Clinical and RX examination,The patient will be recalled for control .Clinical failure was determined by the subjective symptoms as explained by the participants and objective signs as recorded during clinical examination including abscess.	12 months
Pathological Mobility	Clinical examination,The patient will be recalled for control.Clinical failure was determined by the subjective symptoms as explained by the participants and objective signs as recorded during clinical examination including mobility.	12 months

Collaborators and Investigators

• Sponsor: Universitat Internacional de Catalunya

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2017
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): December 12, 2024

Study Registration Dates

• First Submitted: June 30, 2020
• First Submitted That Met QC Criteria: May 20, 2021
• First Posted (Actual): May 26, 2021

Study Record Updates

• Last Update Posted (Actual): April 5, 2024
• Last Update Submitted That Met QC Criteria: April 4, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antineoplastic Agents; Folic Acid Antagonists; Pemetrexed
• Other Study ID Numbers: UIC (University of Illinois at Chicago)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No