Efficacy of Integrated Nano-technology in Revascularization of Immature Necrotic Teeth
1 other identifier
interventional
20
0 countries
N/A
Brief Summary
This trial aims to study the effect of photoactivated disinfection using Diod laser (810 nm) to activate photosensitive nanoparticle chitosan as an endodontic irrigant versus sodium hypochlorite followed by saline and then EDTA 17% on 1) postoperative pain and 2) the success of revascularization in patients with necrotic immature maxillary anterior teeth using a randomized clinical trial design.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2024
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 13, 2024
CompletedFirst Posted
Study publicly available on registry
October 8, 2024
CompletedStudy Start
First participant enrolled
October 11, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 11, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 11, 2025
CompletedOctober 8, 2024
October 1, 2024
1 month
September 13, 2024
October 7, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
pain intensity assessed by numerical rating scale
postoperative pain using numerical rating scale
24 hours and 1 week after completion of the procedure
Secondary Outcomes (3)
root development
6 months, 1 year postoperative
Apical foramen closure
6 months, 1 year postoperative
periapical bone healing
6 months, 1 year postoperative
Study Arms (2)
control group: using AAE protocol
ACTIVE COMPARATORrevascularization using blood clot according to the standardized protocol of the American association of endodontics
test group
EXPERIMENTALdiode laser will be used to activate photosensitized nano chitosan 2% for canal disinfection instead of NaOCl in the first visit of revascularization protocol
Interventions
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
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Minia Universitylead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- assisstant lecturer of endodontics
Study Record Dates
First Submitted
September 13, 2024
First Posted
October 8, 2024
Study Start
October 11, 2024
Primary Completion
November 11, 2024
Study Completion
April 11, 2025
Last Updated
October 8, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share