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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
Sponsor:
Information provided by (Responsible Party):
Vineet Dhar, University of Maryland Baltimore Dental School

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.

Condition or disease Intervention/treatment Phase
Vital Pulp Therapies Indirect Pulp Cap Pulpotomy Drug: Mineral Trioxide Aggregate Drug: Biodentin Drug: Vitrebond Phase 4

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 156 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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

Arm Intervention/treatment
Experimental: Indirect pulp cap
IDP will be performed for this group
Drug: Vitrebond
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
Drug: Biodentin



Primary Outcome Measures :
  1. 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

  2. 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

  3. 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



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Ages Eligible for Study:   2 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pediatric patients with deep dental decay in primary molars
  • Teeth with signs and symptoms of reversible pulpitis

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

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


Contacts
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Contact: Vineet Dhar, MDS, PhD 4107067970 vdhar@umaryland.edu

Locations
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United States, Maryland
University of Maryland School of Dentistry Recruiting
Baltimore, Maryland, United States, 21043
Contact: Vineet Dhar       vdhar@umaryland.edu   
Sponsors and Collaborators
University of Maryland Baltimore Dental School

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Responsible Party: Vineet Dhar, Associate Professor, Graduate Program Director, University of Maryland Baltimore Dental School
ClinicalTrials.gov Identifier: NCT02298504     History of Changes
Other Study ID Numbers: HP-00058711
First Posted: November 24, 2014    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: April 2018