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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)

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06631885
Enrollment
20
Registered
2024-10-08
Start date
2024-10-11
Completion date
2025-04-11
Last updated
2024-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immature Teeth, Necrotic Pulp

Keywords

regenerative endodontic procedure

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.

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.

Interventions

PROCEDUREregenerative endodontic procedure using blood clot according to AAE

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

PROCEDUREregenerative endodontic procedure using photo activated nanochitosan 2%

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

Sponsors

Minia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
pain intensity assessed by numerical rating scale24 hours and 1 week after completion of the procedurepostoperative pain using numerical rating scale

Secondary

MeasureTime frameDescription
root development6 months, 1 year postoperativechange of root length
Apical foramen closure6 months, 1 year postoperativechange in apical foramen diameter
periapical bone healing6 months, 1 year postoperativechange in the area of periapical lesion

Contacts

Primary ContactMohamed Abdelmawla, assisstant lecturer
dr.mohammed.abdelmawla@gmail.com+20-1005757045

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026