Efficacy of Integrated Nano-technology in Revascularization of Immature Necrotic Teeth

NCT ID: NCT06631885

Last Updated: 2024-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-11

Study Completion Date

2025-04-11

Brief Summary

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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

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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.

Conditions

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Immature Teeth Necrotic Pulp

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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control group: using AAE protocol

revascularization using blood clot according to the standardized protocol of the American association of endodontics

Group Type ACTIVE_COMPARATOR

regenerative endodontic procedure using blood clot according to AAE

Intervention Type PROCEDURE

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

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

Group Type EXPERIMENTAL

regenerative endodontic procedure using photo activated nanochitosan 2%

Intervention Type PROCEDURE

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

Interventions

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regenerative 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

Intervention Type PROCEDURE

regenerative 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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Minia University

OTHER

Sponsor Role lead

Responsible Party

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Mohammed abdelmawla mohammed

assisstant lecturer of endodontics

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Mohamed Abdelmawla, assisstant lecturer

Role: CONTACT

+20-1005757045

Other Identifiers

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(586/2022)

Identifier Type: -

Identifier Source: org_study_id

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