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

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

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03395496
Enrollment
200
Registered
2018-01-10
Start date
2013-05-01
Completion date
2016-05-30
Last updated
2018-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Caries, Pulpotomy

Keywords

pulpotomy, pediatric dentistry, primary molars

Brief summary

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.

Interventions

DRUGBiodentine

Biodentine pulpotomy agent

ProRoot MTA pulpotomy agent

Sponsors

Istanbul University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
7 Years to 15 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Total success rate12 months after pulpotomy treatment

Secondary

MeasureTime frame
Total success rate24 months after pulpotomy treatment

Other

MeasureTime frame
Total success rate36 months after pulpotomy treatment

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026