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Clinical Trials/NCT04018456
NCT04018456
Completed
Not Applicable

Regenerative Root Canal Treatment of Mature Teeth With Pulp Necrosis and Apical Periodontitis Using Biodentine Compared With MTA: Randomized Clinical Double-blind Trial

Cairo University1 site in 1 country36 target enrollmentAugust 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Necrotic Pulp
Sponsor
Cairo University
Enrollment
36
Locations
1
Primary Endpoint
Discoloration of teeth
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

The aim of this prospective, randomized, controlled double-blind study is to evaluate the effectiveness of biodentine compared with MTA used as pulp space barrier on discoloration of teeth after regenerative based non-obturation root canal treatment in mature single canal with pulp necrosis and apical periodontitis.

Detailed Description

• Regenerative endodontic treatment will be performed through two visits: First visit aims to clean and disinfect the tooth canal by copious irrigation with NaOCL and EDTA solution . At the end of first visit, canal will be dressed by CaOH as intracanal medicaments. Second visit will be after two weeks. After removal of CaOH dressing by copius irrigation, evoking bleeding inside canal by over instrumentation. When blood become semi-coagulated, according to the random sequence number of the participants, either biodentine or white MTA will be placed as pulp space barrier. At the end of treatment, the access cavity will be sealed with composite restoration.

Registry
clinicaltrials.gov
Start Date
August 1, 2021
End Date
June 1, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Amatallah Hussein Nasser Al-Rawhani

Principle investigator

Cairo University

Eligibility Criteria

Inclusion Criteria

  • Tooth type: single-rooted teeth (anterior or premolar) encasing of one root canal with mature root (closed apex).
  • Negative response of pulp tissue to electrical or thermal pulp tester.
  • Widening in lamina dura or periapical radiolucency not more than 3 mm.

Exclusion Criteria

  • Patients having significant systemic disorder or immunocompromised patients.
  • Teeth with generalized chronic periodontitis or have periodontal pocket larger than 3 mm.
  • Teeth with developmental anomalies (i.e, dens invaginatusor a palatogingival groove).
  • Teeth with previous root canal.
  • Teeth need to post and core as final restoration

Outcomes

Primary Outcomes

Discoloration of teeth

Time Frame: Up to one Year after completion of regenerative endodontic treatment

Discoloration of teeth that will be assessed clinically through follow up period 3, 6, 9, 12 months by visual examination and by using color shade guide (Tetric N shade guide, Ivoclar Vivadent) whether tooth discolored or not in comparison with the original preoperative color shade.

Secondary Outcomes

  • Healing of Periapical Tissue(after 3, 6,9 and Up to 12 months after completion of regenerative endodontic treatment)
  • Restoring the sensibility of tooth(after 6,9 and Up to 12 months after completion of regenerative endodontic treatment)

Study Sites (1)

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