Back to resultsRegenerative Endodontic Treatment of Mature Necrotic Teeth With Apical Periodontitis
Primary Purpose
Necrotic Pulp, Apical Periodontitis
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Biodentine
White MTA
Sponsored by
About this trial
This is an interventional treatment trial for Necrotic Pulp focused on measuring Necrotic pulp,, Apical periodontitis, Regeneration, MTA, Biodentine
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:
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
Sites / Locations
- Dentistry Faculty
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Biodentine
White MTA
Arm Description
Intervention group: application of biodentine as pulp space barrier during regenerative endodontic treatment.
Control group: application of White MTA as pulp space barrier during regenerative endodontic treatment.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Restoring the sensibility of tooth
Electric pulp tester (EPT)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04018456
Brief Title
Regenerative Endodontic Treatment of Mature Necrotic Teeth With Apical Periodontitis
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
November 1, 2022 (Actual)
Study Completion Date
June 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Necrotic Pulp, Apical Periodontitis
Keywords
Necrotic pulp,, Apical periodontitis, Regeneration, MTA, Biodentine
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Participants/ outcome assessor will be blinded
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Biodentine
Arm Type
Experimental
Arm Description
Intervention group: application of biodentine as pulp space barrier during regenerative endodontic treatment.
Arm Title
White MTA
Arm Type
Active Comparator
Arm Description
Control group: application of White MTA as pulp space barrier during regenerative endodontic treatment.
Intervention Type
Other
Intervention Name(s)
Biodentine
Intervention Description
Biodentine is calcium silicate based cement which is bioactive and inductive material. Biodentine will be applied as coronal plug material.
Intervention Type
Other
Intervention Name(s)
White MTA
Other Intervention Name(s)
white mineral trioxide aggregate
Intervention Description
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.
Primary Outcome Measure Information:
Title
Discoloration of teeth
Description
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.
Time Frame
Up to one Year after completion of regenerative endodontic treatment
Secondary Outcome Measure Information:
Title
Healing of Periapical Tissue
Description
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.
Time Frame
after 3, 6,9 and Up to 12 months after completion of regenerative endodontic treatment
Title
Restoring the sensibility of tooth
Description
Electric pulp tester (EPT)
Time Frame
after 6,9 and Up to 12 months after completion of regenerative endodontic treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amatallah HN Al-Rawhani, Master
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dentistry Faculty
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31155298
Citation
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: 10.1016/j.joen.2019.04.005. Epub 2019 May 31.
Results Reference
result
Learn more about this trial
Regenerative Endodontic Treatment of Mature Necrotic Teeth With Apical Periodontitis
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