Vital Pulp Treatment in Primary Teeth
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|ClinicalTrials.gov Identifier: NCT02298504|
Recruitment Status : Recruiting
First Posted : November 24, 2014
Last Update Posted : May 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Vital Pulp Therapies Indirect Pulp Cap Pulpotomy||Drug: Mineral Trioxide Aggregate Drug: Biodentin Drug: Vitrebond||Phase 4|
Pediatric patients having deep decay in primary molars seen at UMMC, UMSOD, and University of Maryland Rehabilitation and Orthopaedic Institute, will be included in the sample. Teeth with deep caries, >50% into dentin, will be randomly assigned using a table of random numbers to the three treatment groups:
Group 1 pulpotomy with MTA, Group 2 pulpotomy with Biodentine, Group 3 indirect pulp treatment. Treatment will be performed by board certified pediatric dentists or they will directly supervise pediatric dental residents at each site as part of their regular protocol for treating deep caries.
Radiographs will be taken as prescribed in the Guideline for taking Radiographs in Children by the American Academy of Pediatric Dentistry.
Twice yearly clinical examinations will be performed by the treating dentists or pediatric dental residents to check for any soft tissue pathology such as abscess or mobility of treated tooth/teeth. If treatment success/failure consensus between the blinded dentists is not reached, a third dentist will be consulted.
The success/failure data will be entered onto spreadsheets and examined statistically using statistical software.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||156 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Evaluation of MTA Pulpotomy, Biodentine Pulpotomy, and Glass Ionomer Indirect Pulp Treatment in Primary Teeth|
|Actual Study Start Date :||November 2015|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||January 2020|
Experimental: Indirect pulp cap
IDP will be performed for this group
Experimental: MTA pulpotomy
MTA pulpotomy will be performed for this group
Drug: Mineral Trioxide Aggregate
Experimental: Biodentin pulpotomy
Biodentin pulpotomy will be performed for this group
- Clinical success after pulpotomy [ Time Frame: 3 years ]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
- Clinical success after indirect pulp cap [ Time Frame: 3 years ]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
- Radiographic success after pulpotomy [ Time Frame: 3 years ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02298504
|Contact: Vineet Dhar, MDS, PhDemail@example.com|
|United States, Maryland|
|University of Maryland School of Dentistry||Recruiting|
|Baltimore, Maryland, United States, 21043|
|Contact: Vineet Dhar firstname.lastname@example.org|