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NCT Number: NCT02298504

Vital Pulp Treatment in Primary Teeth

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Vital Pulp Therapies Indirect Pulp Cap Pulpotomy

Age range

2 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Maryland School of Dentistry

Baltimore, Maryland, 21043, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mineral Trioxide Aggregate

Drug

Vital pulp therapy

Other names: MTA pulpotomy

Biodentin

Drug

Vital pulp therapy

Other names: Biodentin Pulpotomy

Vitrebond

Device

Vital pulp therapy

Other names: Indirect pulp cap

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2026
Study completion
2026
First posted
Nov 24, 2014
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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