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

Not Applicable

Not yet recruiting

• Conditions: Immature Teeth; Necrotic Pulp
• Interventions: Procedure: regenerative endodontic procedure using blood clot according to AAE; Procedure: regenerative endodontic procedure using photo activated nanochitosan 2%

• Registration Number: NCT06631885
• Lead Sponsor: Minia University

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.

Study Timeline

• Study First Submitted: 2024-09-13
• Status Verified: 2024-10
• Study First Submitted QC: 2024-10-07
• Last Update Submitted: 2024-10-07
• Study First Posted: 2024-10-08
• Last Update Posted: 2024-10-08
• Study Start: 2024-10-11
• Primary Completion: 2024-11-11
• Study Completion: 2025-04-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group: using AAE protocol	regenerative endodontic procedure using blood clot according to AAE	revascularization using blood clot according to the standardized protocol of the American association of endodontics
test group	regenerative endodontic procedure using photo activated nanochitosan 2%	diode laser will be used to activate photosensitized nano chitosan 2% for canal disinfection instead of NaOCl in the first visit of revascularization protocol

Primary Outcome Measures

Name	Time	Method
pain intensity assessed by numerical rating scale	24 hours and 1 week after completion of the procedure	postoperative pain using numerical rating scale

Secondary Outcome Measures

Name	Time	Method
root development	6 months, 1 year postoperative	change of root length
Apical foramen closure	6 months, 1 year postoperative	change in apical foramen diameter
periapical bone healing	6 months, 1 year postoperative	change in the area of periapical lesion