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NCT Number: NCT06631885

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

regenerative endodontic procedure using blood clot according to AAE

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

regenerative endodontic procedure using photo activated nanochitosan 2%

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

Primary outcomes

  1. 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

Secondary outcomes

  1. root development

    Time frame: 6 months, 1 year postoperative

    change of root length

  2. Apical foramen closure

    Time frame: 6 months, 1 year postoperative

    change in apical foramen diameter

  3. periapical bone healing

    Time frame: 6 months, 1 year postoperative

    change in the area of periapical lesion

Study contacts

Contact information is provided by the study sponsor or research team.

Mohamed Abdelmawla, assisstant lecturer

CONTACT

[email protected]

+20-1005757045

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Official study title

Efficacy of Integrated Nano-technology in the Irrigation Protocol of Revascularization Technique In Immature Necrotic Teeth (Randomized Clinical Trial)

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Oct 8, 2024
Registry last updated
Oct 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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