Comparison of Biodentine and MTA Pulpotomies in the Primary Molar Teeth 3 Year Follow up

NCT ID: NCT03395496

Last Updated: 2018-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-01

Study Completion Date

2016-05-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The aim of this study is to compare two pulpotomy medicaments in primary molars clinically.A total of 200 primary molars with deep caries were treated with two different pulpotomy medicaments (Mineral Trioxide Aggregate and BiodentineTM) in this study. The inclusion criteria for tooth selection were no clinical and radiographic evidence of pulp pathology. During 36 months of follow-up at 3-month intervals, clinical and radiographic success and failures were recorded.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pulpotomy Dental Caries

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Biodentine

Dental materials

Group Type EXPERIMENTAL

Biodentine

Intervention Type DRUG

Biodentine pulpotomy agent

ProRoot (Aggregate)

Intervention Type DRUG

ProRoot MTA pulpotomy agent

ProRoot MTA

Dental Materials

Group Type EXPERIMENTAL

Biodentine

Intervention Type DRUG

Biodentine pulpotomy agent

ProRoot (Aggregate)

Intervention Type DRUG

ProRoot MTA pulpotomy agent

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Biodentine

Biodentine pulpotomy agent

Intervention Type DRUG

ProRoot (Aggregate)

ProRoot MTA pulpotomy agent

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

77509635 75896452

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* no clinical and radiographic evidence of pulp pathology,
* no clinical and radiographic symptoms,
* no history of spontaneous pain and tenderness,
* no percussion, swelling or sinus tracts and pathologic mobility.

Exclusion Criteria

* any clinical or radiographic evidence of pulp degeneration (spontaneous or nocturnal tooth pain, tenderness to percussion, pathological mobility, internal or external root resorption, swelling or fistula, widened periodontal ligament (PDL)
* furcal or periapical radiolucency teeth requiring more than 5 minutes to achieve hemostasis during clinical procedure.
* without permanent successor
Minimum Eligible Age

7 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Istanbul University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mine Koruyucu

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Istanbul University

Istanbul, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2017-24692

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.