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

Primary Molar Pulpotomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04902495
• Other study ID #: UIC
• Status: Recruiting
• Phase: N/A
• Start date: January 12, 2017
• Est. completion date: December 12, 2024

Study information

• Verified date: April 2024
• Source: Universitat Internacional de Catalunya
• Contact: Francisco Guinot Jimeno, DDS, MsC
• Phone: 0034 93 504 50 00
• Email: fguinot79[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 61
• Est. completion date: December 12, 2024
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 9 Years

Eligibility

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.

Related Conditions & MeSH terms

• Primary Molar Pulpotomy

Intervention

Other:
• MTA Pro Root
pulp therapy
• MTA HP Repair
pulp therapy
• Biodentine
pulp therapy

Locations

Country	Name	City	State
Spain	Universitat Internacional de Catalunya	Sant Cugat del Valles	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Universitat Internacional de Catalunya

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Radiographic Success	RX examination,Radiographic evaluation if success was performed according evidence of perirradicular or furcation pathosis or pathology root resorption.	12 months
Secondary	Radicular Radiolucency	RX examination,Radiographic evaluation if success was performed according evidence of perirradicular or furcation pathosis.	12 months
Secondary	Internal Resorption	RX examination,Radiographic evaluation if success was performed according evidence of pathology root resorption.	12 months
Secondary	External Resorption	RX examination,Radiographic evaluation if success was performed according evidence of pathology root resorption.	12 months
Secondary	Furcation Radiolucency	RX examination,Radiographic evaluation if success was performed according evidence of perirradicular or furcation pathosis.	12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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