Vital Pulp Treatment in Primary Teeth

Pulpotomy Clinical Trial

Official title:

Evaluation of MTA Pulpotomy, Biodentine Pulpotomy, and Glass Ionomer Indirect Pulp Treatment in Primary Teeth

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02298504
• Other study ID #: HP-00058711
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: July 1, 2018
• Est. completion date: February 2025

Study information

• Verified date: February 2024
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 76
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 9 Years

Eligibility

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

Related Conditions & MeSH terms

• Indirect Pulp Cap
• Pulpotomy
• Vital Pulp Therapies

Intervention

Drug:
• Mineral Trioxide Aggregate
Vital pulp therapy
• Biodentin
Vital pulp therapy

Device:
• Vitrebond
Vital pulp therapy

Locations

Country	Name	City	State
United States	University of Maryland School of Dentistry	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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