Evaluation of Biodentine and Mineral Trioxide Aggregate in Revascularization of Non Vital Immature Anterior Teeth

NCT03589560 | Completed

• 1 other identifier: pulp revascularization
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

Brief Summary

the object of this study is to evaluate clinically and radiographically the effect of using Biodentine and Mineral Trioxide Aggregate as coronal plug materials in revascularization of non-vital immature teeth

Conditions

Pulp Necrosis

Keywords

revascularization; necrotic; immature; coronal plug

Outcome Measures

Primary Outcomes (4)

• pain on biting

  Binary outcome (Present or absent). Assessed by asking the patient

  3 months

• pain on biting

  Binary outcome (Present or absent). Assessed by asking the patient

  6 months

• pain on biting

  Binary outcome (Present or absent). Assessed by asking the patient

  9 months

• pain on biting

  Binary outcome (Present or absent). Assessed by asking the patient

  12 months

Secondary Outcomes (7)

• pain on percussion

  3, 6, 9, 12 month

• swelling

  3, 6, 9, 12 month

• mobility

  3, 6, 9, 12 month

• Sinus or fistula

  3, 6, 9, 12 month

• crown discoloration

  3, 6, 9, 12 month

Study Arms (2)

Biodentine

EXPERIMENTAL

3-4 mm of Biodentine (Septodont, St. Maur-des-Fosses, France) was applied over the clot carefully in group I by using amalgam carrier. material was packed lightly with a moistened cotton pellet and Periapical radiograph was taken to confirm coronal seal in the second visit of dental pulp revascularization.

Drug: Biodentine

Mineral Trioxide Aggregate

ACTIVE COMPARATOR

3-4 mm of white Mineral Trioxide Aggregate (Angelus, Londrina, Brazil) was applied over the clot in group II by using amalgam carrier. material was packed lightly with a moistened cotton pellet and Periapical radiograph was taken to confirm coronal seal in the second visit of dental pulp revascularization.

Drug: Mineral Trioxide Aggregate

Interventions

Biodentine DRUG

a procedure used to regenerate a pulp-dentine complex that restores functional properties of this tissue, fosters continued root development for immature teeth, and prevents or resolves apical periodontitis.

Also known as: Dentine substitute material

Biodentine

Mineral Trioxide Aggregate DRUG

a procedure used to regenerate a pulp-dentine complex that restores functional properties of this tissue, fosters continued root development for immature teeth, and prevents or resolves apical periodontitis.

Also known as: MTA

Mineral Trioxide Aggregate

Eligibility Criteria

• Age: 8 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Patients free from any systemic diseases that may hinder the normal healing process.
• Age from 8-15 y
• Tooth with immature root apex (apical opening greater than 1mm)
• Traumatically or cariously exposed single rooted teeth
• Non vital permanent anterior tooth with apical periodontitis/abscess
• Pulp space not requiring post and core for final restoration.

You may not qualify if:

• Patients having allergy to medicaments or antibiotics necessary to complete procedure.
• Tooth with vital pulp or complete root formation.
• Teeth with internal or external root resorption.
• Un-cooperative patient

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Dental Pulp Necrosis; Necrosis

Interventions

tricalcium silicate; mineral trioxide aggregate; Pemetrexed

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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

• Randa Youssef, PHD

  Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Pediatric Dentistry and Dental public health, Faculty of Dentistry, Cairo University, Egypt.

Study Record Dates

• First Submitted: June 24, 2018
• First Posted: July 18, 2018
• Study Start: January 15, 2015
• Primary Completion: August 15, 2017
• Study Completion: January 15, 2018
• Last Updated: July 18, 2018

Record last verified: 2018-07