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Regenerative Endodontic Treatment of Mature Necrotic Teeth With Apical Periodontitis

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04018456
Enrollment
36
Registered
2019-07-12
Start date
2021-08-01
Completion date
2023-06-01
Last updated
2024-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Apical Periodontitis, Necrotic Pulp

Keywords

Necrotic pulp,, Apical periodontitis, Regeneration, MTA, Biodentine

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.

Interventions

OTHERBiodentine

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

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.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

Participants/ outcome assessor will be blinded

Eligibility

Sex/Gender
ALL
Age
10 Years to 45 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Discoloration of teethUp to one Year after completion of regenerative endodontic treatmentDiscoloration 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

MeasureTime frameDescription
Healing of Periapical Tissueafter 3, 6,9 and Up to 12 months after completion of regenerative endodontic treatmentHealing 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 toothafter 6,9 and Up to 12 months after completion of regenerative endodontic treatmentElectric pulp tester (EPT)

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026