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Completed

NCT Number: NCT04018456

Regenerative Endodontic Treatment of Mature Necrotic Teeth With Apical Periodontitis

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.

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Key information

Conditions

Necrotic Pulp Apical Periodontitis Dental Pulp Diseases Dental Pulp Necrosis Jaw Diseases Mouth Diseases Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Periapical Diseases Periapical Periodontitis Periodontal Diseases Periodontitis Stomatognathic Diseases Tooth Diseases

Age range

10 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dentistry Faculty

Cairo, Egypt

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

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

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

  • 1. Patients having significant systemic disorder or immunocompromised patients. 2. 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. 5. Teeth need to post and core as final restoration

Treatment and study plan

Biodentine

Other

Biodentine is calcium silicate based cement which is bioactive and inductive material. Biodentine will be applied as coronal plug material.

White MTA

Other

MTA is calcium silicate based cement which is bioactive and inductive material. MTA is used in most cases of regenerative endodontics and it will be applied as coronal plug material.

Other names: white mineral trioxide aggregate

Primary outcomes

  1. 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

  1. Healing of Periapical Tissue

    Time frame: after 3, 6,9 and Up to 12 months after completion of regenerative endodontic treatment

    Healing of periapical tissue will be assessed clinically and radiographically through follow up period: 3, 6, 9, 12 months. When the case is clinically asymptomatic: (without sinus tract, swelling, with no palpation, or percussions pain) and radiographically showed absence or reduction of the radiolucency are together will considered successful of regenerative treatment.

  2. Restoring the sensibility of tooth

    Time frame: after 6,9 and Up to 12 months after completion of regenerative endodontic treatment

    Electric pulp tester (EPT)

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Jul 12, 2019
Registry last updated
Jan 23, 2024

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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