Vital Pulp Treatment in Primary Teeth
Evaluation of MTA Pulpotomy, Biodentine Pulpotomy, and Glass Ionomer Indirect Pulp Treatment in Primary Teeth
1 other identifier
interventional
76
1 country
1
Brief Summary
In primary teeth, decay that is near the pulp (tooth nerve)is treated with either a pulpotomy or indirect pulp treatment if the tooth is not going to be extracted A pulpotomy involves removing the top 1/2 of the pulp, placing a medication/material on the pulp, covering the remaining pulp with a cement, and the restoring the tooth. The purpose of this pilot study is to gain preliminary information regarding the success of Biodentine, MTA, and IPT in the treatment of deep decay in children's primary molars.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jul 2018
Longer than P75 for phase_4
1 active site
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
First Submitted
Initial submission to the registry
November 14, 2014
CompletedFirst Posted
Study publicly available on registry
November 24, 2014
CompletedStudy Start
First participant enrolled
July 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
January 23, 2026
January 1, 2026
8.4 years
November 14, 2014
January 22, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
Clinical success after pulpotomy
No signs of abscess or any swelling related to the tooth, no signs of fistula or other pathology, no signs of pathologic mobility, no post-operative pain, no pain on palpation or percussion of the tooth
3 years
Clinical success after indirect pulp cap
No signs of abscess or any swelling related to the tooth, no signs of fistula or other pathology, no signs of pathologic mobility, no post-operative pain, no pain on palpation or percussion of the tooth
3 years
Radiographic success after pulpotomy
No signs of root resorption (internal or external), no signs of furcation involvement or periapical radiolucency, no signs of loss of lamina dura, presence of normal appearance of periodontal ligament space
3 years
Study Arms (3)
Indirect pulp cap
EXPERIMENTALIDP will be performed for this group
MTA pulpotomy
EXPERIMENTALMTA pulpotomy will be performed for this group
Biodentin pulpotomy
EXPERIMENTALBiodentin pulpotomy will be performed for this group
Interventions
Eligibility Criteria
You may qualify if:
- Pediatric patients with deep dental decay in primary molars
- Teeth with signs and symptoms of reversible pulpitis
You may not qualify if:
- Teeth with clinical symptoms of irriversible pulpitis or pulp necrosis or acute dental infection
- Children with systemic illness that contraindicated vital pulp treatment such a sickle cell disease
- Teeth that are not restorable
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Maryland School of Dentistry
Baltimore, Maryland, 21043, United States
MeSH Terms
Interventions
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor, Graduate Program Director
Study Record Dates
First Submitted
November 14, 2014
First Posted
November 24, 2014
Study Start
July 1, 2018
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
January 23, 2026
Record last verified: 2026-01