Efficacy of Integrated Nano-technology in Revascularization of Immature Necrotic Teeth
Efficacy of Integrated Nano-technology in the Irrigation Protocol of Revascularization Technique In Immature Necrotic Teeth (Randomized Clinical Trial)
Study Overview
Status
Conditions
Detailed Description
randomized clinical trial will be conducted to investigate and compare the efficacy of photosensitized nano-chitosan 2% as an endodontic disinfectant during revascularization versus sodium hypochlorite, followed by EDTA 17% according to the standardized protocol of the American Association of endodontics.
Twenty individuals with necrotic, immature permanent anterior teeth will be recruited. They will be randomly assigned into two groups according to the received intervention: control group and test group.
pain will be evaluated as a primary outcome at 24 hours and one week post-intervention using numerical rating scale (NRS). In addition, the root development in terms of change in root length and apical foramen diameter and periapical bone healing will be evaluated as secondary outcomes using cone beam tomography.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mohamed Abdelmawla, assisstant lecturer
- Phone Number: +20-1005757045
- Email: dr.mohammed.abdelmawla@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
o Immature necrotic maxillary incisor with open apex greater than 1 mm.
- Teeth where pulp space are not needed for post and core.
- A restorable tooth.
- 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:
o Non-restorable teeth.
- Teeth with root fractures, internal or external root resorption.
- Teeth with mature fully developed root with closed apex
- Patients with any systemic disease that may affect predictable outcome
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: control group: using AAE protocol
revascularization using blood clot according to the standardized protocol of the American association of endodontics
|
regenerative endodontic procedure using blood clot to replace the necrotic pulp tissues in immature teeth with a pulp like to tissue to complete root development.
using AAE protocol
|
|
Experimental: test group
diode laser will be used to activate photosensitized nano chitosan 2% for canal disinfection instead of NaOCl in the first visit of revascularization protocol
|
regenerative endodontic procedure using blood clot to replace the necrotic pulp tissues in immature teeth with a pulp like to tissue to complete root development.
using photosensitized nanochitosan for root canal disinfection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
pain intensity assessed by numerical rating scale
Time Frame: 24 hours and 1 week after completion of the procedure
|
postoperative pain using numerical rating scale
|
24 hours and 1 week after completion of the procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
root development
Time Frame: 6 months, 1 year postoperative
|
change of root length
|
6 months, 1 year postoperative
|
|
Apical foramen closure
Time Frame: 6 months, 1 year postoperative
|
change in apical foramen diameter
|
6 months, 1 year postoperative
|
|
periapical bone healing
Time Frame: 6 months, 1 year postoperative
|
change in the area of periapical lesion
|
6 months, 1 year postoperative
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- (586/2022)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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