Regenerative Endodontic Treatment of Mature Necrotic Teeth With Apical Periodontitis

Apical Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04018456
• Other study ID #: CU-2019-7-7
• Status: Completed
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: June 1, 2023

Study information

• Verified date: January 2024
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: June 1, 2023
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 45 Years

Eligibility

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.

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

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

Related Conditions & MeSH terms

• Apical Periodontitis
• Dental Pulp Necrosis
• Necrosis
• Necrotic Pulp
• Periapical Periodontitis
• Periodontitis

Intervention

Other:
• Biodentine
Biodentine is calcium silicate based cement which is bioactive and inductive material. Biodentine will be applied as coronal plug material.
• White MTA
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.

Locations

Country	Name	City	State
Egypt	Dentistry Faculty	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Arslan H, Ahmed HMA, Sahin Y, Doganay Yildiz E, Gundogdu EC, Guven Y, Khalilov R. Regenerative Endodontic Procedures in Necrotic Mature Teeth with Periapical Radiolucencies: A Preliminary Randomized Clinical Study. J Endod. 2019 Jul;45(7):863-872. doi: 10 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Discoloration of teeth	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.	Up to one Year after completion of regenerative endodontic treatment
Secondary	Healing of Periapical Tissue	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.	after 3, 6,9 and Up to 12 months after completion of regenerative endodontic treatment
Secondary	Restoring the sensibility of tooth	Electric pulp tester (EPT)	after 6,9 and Up to 12 months after completion of regenerative endodontic treatment