Back to resultsAssessment of Regenerative Potential of Mature Permanent Teeth With Necrotic Pulps Using Two Revascularization Protocols. (In Vivo Study)
Primary Purpose
Apical Periodontitis
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Method
Sponsored by
About this trial
This is an interventional treatment trial for Apical Periodontitis
Eligibility Criteria
Inclusion Criteria:
- Patients with mature teeth.
- Patients with periapical periodontitis.
- Maxillary anterior teeth only will be involved.
- Patients should be free from any systemic disease that may affect normal healing and predictable outcome.
- Patients who will agree to the consent and will commit to follow up period.
Exclusion Criteria:
- Patients with immature roots.
- Patients with any systemic disease that may affect normal healing.
- Patients with swelling.
- Pregnant females.
- Patients who could/would not participate in a 1 year follow up.
- Patients with fistula.
- Patients with old age.
- Teeth with periodontal involvement.
- Teeth with vertical root fractures.
- Unrestorable teeth.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Blood clotting protocol for pulp regeneration
platelet rich fibrin for pulp regeneration
Arm Description
pulp regeneration for mature teeth using blood clotting protocol
pulp regeneration for mature teeth using platelet rich fibrin (PRF)
Outcomes
Primary Outcome Measures
clinical success
pulp vitality testing using electric pulp tester which detect response of pulp to electric current
radiographic success
healing of apical periodontitis by detecting change in apical radiolucency and absences of apical bone resorption
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04158232
Brief Title
Assessment of Regenerative Potential of Mature Permanent Teeth With Necrotic Pulps Using Two Revascularization Protocols. (In Vivo Study)
Official Title
Assessment of Regenerative Potential of Mature Permanent Teeth With Necrotic Pulps Using Two Revascularization Protocols. (In Vivo Study)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 2, 2019 (Anticipated)
Primary Completion Date
September 2, 2020 (Anticipated)
Study Completion Date
November 2, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Minia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Regenerative endodontic procedures have been used to successfully treat human mature permanent teeth with necrotic pulps and apical periodontitis. Many researchers have begun to apply regenerative endodontic procedures to mature teeth in adult patients. Several clinical case reports have shown complete resolution of signs and symptoms of pulp necrosis in mature teeth, even those with large periapical lesions, as well as signs of pulp canal obliteration. thevaim of this study is To assess the regenerative potential of mature permanent teeth with necrotic pulps with platelet-rich fibrin (PRF) and blood clot using radiographic and clinical methods.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Apical Periodontitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Blood clotting protocol for pulp regeneration
Arm Type
Active Comparator
Arm Description
pulp regeneration for mature teeth using blood clotting protocol
Arm Title
platelet rich fibrin for pulp regeneration
Arm Type
Experimental
Arm Description
pulp regeneration for mature teeth using platelet rich fibrin (PRF)
Intervention Type
Other
Intervention Name(s)
Method
Intervention Description
treatment of mature teeth with apical periodontitis
Primary Outcome Measure Information:
Title
clinical success
Description
pulp vitality testing using electric pulp tester which detect response of pulp to electric current
Time Frame
9 months
Title
radiographic success
Description
healing of apical periodontitis by detecting change in apical radiolucency and absences of apical bone resorption
Time Frame
9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients with mature teeth.
Patients with periapical periodontitis.
Maxillary anterior teeth only will be involved.
Patients should be free from any systemic disease that may affect normal healing and predictable outcome.
Patients who will agree to the consent and will commit to follow up period.
Exclusion Criteria:
Patients with immature roots.
Patients with any systemic disease that may affect normal healing.
Patients with swelling.
Pregnant females.
Patients who could/would not participate in a 1 year follow up.
Patients with fistula.
Patients with old age.
Teeth with periodontal involvement.
Teeth with vertical root fractures.
Unrestorable teeth.
12. IPD Sharing Statement
Citations:
PubMed Identifier
35030270
Citation
Youssef A, Ali M, ElBolok A, Hassan R. Regenerative endodontic procedures for the treatment of necrotic mature teeth: A preliminary randomized clinical trial. Int Endod J. 2022 Apr;55(4):334-346. doi: 10.1111/iej.13681. Epub 2022 Jan 31.
Results Reference
derived
Learn more about this trial
Assessment of Regenerative Potential of Mature Permanent Teeth With Necrotic Pulps Using Two Revascularization Protocols. (In Vivo Study)
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