Regenerative Endodontic Treatment of Mature Necrotic Teeth With Apical Periodontitis

Not Applicable

Completed

• Conditions: Necrotic Pulp; Apical Periodontitis
• Interventions: Other: White MTA; Other: Biodentine

• Registration Number: NCT04018456
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study First Submitted: 2019-07-07
• Study First Submitted QC: 2019-07-11
• Study First Posted: 2019-07-12
• Study Start: 2021-08-01
• Primary Completion: 2022-01-01
• Study Completion: 2023-06-01
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-21
• Last Update Posted: 2024-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

1. Tooth type: single-rooted teeth (anterior or premolar) encasing of one root canal with mature root (closed apex).
2. Negative response of pulp tissue to electrical or thermal pulp tester.
3. 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.

  2. Teeth with developmental anomalies (i.e, dens invaginatusor a palatogingival groove).

  3. Teeth with previous root canal. 5. Teeth need to post and core as final restoration

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
White MTA	White MTA	Control group: application of White MTA as pulp space barrier during regenerative endodontic treatment.
Biodentine	Biodentine	Intervention group: application of biodentine as pulp space barrier during regenerative endodontic treatment.

Primary Outcome Measures

Name	Time	Method
Discoloration of teeth	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 Outcome Measures

Name	Time	Method
Healing of Periapical Tissue	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.
Restoring the sensibility of tooth	after 6,9 and Up to 12 months after completion of regenerative endodontic treatment	Electric pulp tester (EPT)

Trial Locations

Locations (1)

Dentistry Faculty; 🇪🇬 Cairo, Egypt