Back to resultsUsing Three Different Final Irrigants and Showing Their Effects on the Success of Revascularization
Primary Purpose
Post-operative Pain
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Propolis
Nano-propolis
saline
Sponsored by
About this trial
This is an interventional other trial for Post-operative Pain
Eligibility Criteria
Inclusion Criteria:
- mature teeth.
- teeth with periapical periodontitis.
- Maxillary anterior teeth
- Patients should be free from any systemic disease
- 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. .Non-restorable teeth.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
propolis
Nano-propolis
saline
Arm Description
natural antibacterial, anti-inflammatory irrigation solution
natural antibacterial, anti-inflammatory irrigation solution
sodium chloride irrigation solution
Outcomes
Primary Outcome Measures
post-operative pain: Visual analogue scale
post-operative pain evaluated using Visual analogue scale , 0 no pain, 10 severe pain.
Secondary Outcome Measures
periapical healing
evaluated radiographically
sensitivity
electric pulp tester
survival
clinical evaluation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03591172
Brief Title
Using Three Different Final Irrigants and Showing Their Effects on the Success of Revascularization
Official Title
Assessment of Implementing Nano-technology in the Irrigation Protocol of One Step Revascularization For Necrotic Mature Teeth
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 2018 (Anticipated)
Primary Completion Date
November 2018 (Anticipated)
Study Completion Date
September 2019 (Anticipated)
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
5. Study Description
Brief Summary
this study will assess different irrigating materials on the success revascularization of necrotic mature teeth associated with PRF.
Detailed Description
Nano-propolis and Propolis will be used as final endodontic irrigants and will be compared to saline in Revascularization of necrotic mature teeth.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-operative Pain
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
propolis
Arm Type
Experimental
Arm Description
natural antibacterial, anti-inflammatory irrigation solution
Arm Title
Nano-propolis
Arm Type
Experimental
Arm Description
natural antibacterial, anti-inflammatory irrigation solution
Arm Title
saline
Arm Type
Active Comparator
Arm Description
sodium chloride irrigation solution
Intervention Type
Drug
Intervention Name(s)
Propolis
Other Intervention Name(s)
natural irrigant
Intervention Description
Using propolis as a final irrigation in revascularization
Intervention Type
Drug
Intervention Name(s)
Nano-propolis
Other Intervention Name(s)
Natural irrigant
Intervention Description
Using Nano-propolis as a final irrigation in revasculariztion
Intervention Type
Drug
Intervention Name(s)
saline
Other Intervention Name(s)
sodium chloride
Intervention Description
Using saline as a final irrigation in revasculariztion
Primary Outcome Measure Information:
Title
post-operative pain: Visual analogue scale
Description
post-operative pain evaluated using Visual analogue scale , 0 no pain, 10 severe pain.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
periapical healing
Description
evaluated radiographically
Time Frame
1 year
Title
sensitivity
Description
electric pulp tester
Time Frame
1 year
Title
survival
Description
clinical evaluation
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
mature teeth.
teeth with periapical periodontitis.
Maxillary anterior teeth
Patients should be free from any systemic disease
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. .Non-restorable teeth.
12. IPD Sharing Statement
Learn more about this trial
Using Three Different Final Irrigants and Showing Their Effects on the Success of Revascularization
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