NCT04902495

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 12, 2017

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

June 30, 2020

Completed
11 months until next milestone

First Posted

Study publicly available on registry

May 26, 2021

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2024

Completed
Last Updated

April 5, 2024

Status Verified

April 1, 2024

Enrollment Period

7.8 years

First QC Date

June 30, 2020

Last Update Submit

April 4, 2024

Conditions

Primary Molar Pulpotomy

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (8)

  • Radicular Radiolucency

    12 months

  • Internal Resorption

    12 months

  • External Resorption

    12 months

  • Furcation Radiolucency

    12 months

  • Symptoms of pain

    12 months

  • +3 more secondary outcomes

Study Arms (3)

Pulp Dressing MTA Angelus

EXPERIMENTAL

pulp therapy

Other: MTA HP Repair

Pulp Dressing MTA Pro Root

EXPERIMENTAL

pulp therapy

Other: MTA Pro Root

Pulp Dressing Biodentine

EXPERIMENTAL

pulp therapy

Other: Biodentine

Interventions

BiodentineOTHER

pulp therapy

Pulp Dressing Biodentine
MTA Pro RootOTHER

pulp therapy

Pulp Dressing MTA Pro Root
MTA HP RepairOTHER

pulp therapy

Pulp Dressing MTA Angelus

Eligibility Criteria

Age4 Years - 9 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitat Internacional de Catalunya

Sant Cugat del Vallès, Barcelona, 08195, Spain

RECRUITING

MeSH Terms

Interventions

tricalcium silicate

Central Study Contacts

Francisco Guinot Jimeno, DDS, MsC

CONTACT

0034 93 504 50 00fguinot79@hotmail.com

ANA VELOSO DURAN, DDS, MsC

CONTACT

0034 93 504 50 00ana_veloso13@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the pediatric dentistry department.

Study Record Dates

First Submitted

June 30, 2020

First Posted

May 26, 2021

Study Start

January 12, 2017

Primary Completion

November 1, 2024

Study Completion

December 12, 2024

Last Updated

April 5, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)