Similar Outcomes of Vital Pulp Therapy Using Mineral Trioxide Aggregate or Biodentine™

NCT03186690 | Unknown

• 1 other identifier: 154/2013
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to evaluate the clinical performance of White MTA (MTA, Angelus, Londrina, Brazil) and Biodentine™ in pulp capping of cariously exposed mature permanent teeth. The investigator performed a prospective longitudinal randomized controlled study utilizing vital permanent mature teeth with deep caries. Patients will be divided randomly into Biodentine™ and MTA groups; Teeth will be assessed clinically and radiographically prior to the procedure. Caries will be excavated under local anesthesia, hemostasis is achieved after pulp exposure using NaOCl and will be capped with Biodentine™ or MTA. Clinical and radiographical follow-up will be performed by a blinded calibrated evaluator after six months and one year, and yearly after.

Conditions

Deep Caries; Reversible Pulpitis; Irreversible Pulpitis

Keywords

vital pulp therapy; Biodentine; Mineral Trioxide Aggregate

Outcome Measures

Primary Outcomes (1)

• clinical vital pulp therapy success

  Treatment was considered successful based on absence of symptoms and signs

  from date of randomization until failure reported for up to 100 months

Secondary Outcomes (1)

• Radiographic success

  from date of randomization until failure reported for up to 100 months

Study Arms (2)

Biodentine

EXPERIMENTAL

This includes teeth that were treated with Biodntine cement

Other: Biodentine

Mineral Trioxide Aggregate

EXPERIMENTAL

This includes teeth that were treated with Mineral Trioxide Aggregate (MTA) cement

Other: Mineral Trioxide Aggregate

Interventions

Biodentine OTHER

Biodentine

Mineral Trioxide Aggregate OTHER

Also known as: MTA

Mineral Trioxide Aggregate

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Teeth that Fulfilled All the Following Criteria Were Selected
• Vital teeth responding positively to cold test.
• Reversible or irreversible pulpitis with or without periapical lesion.
• Deep caries that if removed exposure of the pulp is most likely to occur.
• Permanent mature molar, premolar or anterior tooth
• The tooth should be restorable.
• No serious medical problem that could prevent the patient from receiving the treatment or attending later the follow up visits.

You may not qualify if:

• Immature tooth
• Unrestorable tooth
• Tooth that did not respond to cold test
• Serious medical problem that could prevent the patient from receiving the treatment or attending later the follow up visits.

Sponsors & Collaborators

• Jordan University of Science and Technology: lead

Study Sites (1)

Dr Lama Awawdeh

Irbid, PO BOX 3030, Jordan

Location

MeSH Terms

Interventions

tricalcium silicate; mineral trioxide aggregate; Pemetrexed

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Officials

• Lama Awawdeh, PhD

  Jordan University of Science and Technology

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants were not aware of type of capping material used.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This prospective longitudinal, parallel-design, randomized clinical trial was set up and is reported according to CONSORT statement

Study Record Dates

• First Submitted: May 27, 2017
• First Posted: June 14, 2017
• Study Start: July 4, 2013
• Primary Completion: December 1, 2020
• Study Completion: October 4, 2023
• Last Updated: September 25, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)