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

Not Applicable

Recruiting

• Conditions: Primary Molar Pulpotomy
• Interventions: Other: Biodentine; Other: MTA HP Repair; Other: MTA Pro Root

• Registration Number: NCT04902495
• Lead Sponsor: Universitat Internacional de Catalunya

Brief Summary

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).

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 Timeline

• Study Start: 2017-01-12
• Study First Submitted: 2020-06-30
• Study First Submitted QC: 2021-05-20
• Study First Posted: 2021-05-26
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-04
• Last Update Posted: 2024-04-05
• Primary Completion: 2024-11-01
• Study Completion: 2024-12-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 61

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pulp Dressing Biodentine	Biodentine	pulp therapy
Pulp Dressing MTA Angelus	MTA HP Repair	pulp therapy
Pulp Dressing MTA Pro Root	MTA Pro Root	pulp therapy

Primary Outcome Measures

Name	Time	Method
visual examination	12 months	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.
Radiographic Success	12 months	RX examination,Radiographic evaluation if success was performed according evidence of perirradicular or furcation pathosis or pathology root resorption.

Secondary Outcome Measures

Name	Time	Method
External Resorption	12 months	RX examination,Radiographic evaluation if success was performed according evidence of pathology root resorption.
Fistulation	12 months	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.
Internal Resorption	12 months	RX examination,Radiographic evaluation if success was performed according evidence of pathology root resorption.
Furcation Radiolucency	12 months	RX examination,Radiographic evaluation if success was performed according evidence of perirradicular or furcation pathosis.
Swelling	12 months	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.
Radicular Radiolucency	12 months	RX examination,Radiographic evaluation if success was performed according evidence of perirradicular or furcation pathosis.
Symptoms of pain	12 months	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.
Pathological Mobility	12 months	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.

Trial Locations

Locations (1)

Universitat Internacional de Catalunya; 🇪🇸 Sant Cugat del Valles, Barcelona, Spain