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Not yet recruitingNCT06631885Updated Oct 8, 2024

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

An interventional study of regenerative endodontic procedure using blood clot according to AAE and regenerative endodontic procedure using photo activated nanochitosan 2% in Immature Teeth and Necrotic Pulp, sponsored by Minia University. Not yet recruiting. Per ClinicalTrials.gov, last updated 2024-10-08.

Sponsored by Minia University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Nov 2024, 2 years ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Immature Teeth
  • Necrotic Pulp

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Keywords

  • regenerative endodontic procedure
03

In context

Dental Pulp Necrosis

157 studies on the registry are indexed under Dental Pulp Necrosis; 44 are open to participants now.

This study's planned enrollment of 20 is below the median of 45 across 148 interventional studies indexed under Dental Pulp Necrosis.

Browse Dental Pulp Necrosis studies →

Lead sponsor

Minia University is the lead sponsor of 370 studies on the registry; 117 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
20 participants (estimated)

Study arms

  • Active comparator
    control group: using AAE protocol

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

    Procedure: regenerative endodontic procedure using blood clot according to AAE

  • Experimental
    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

    Procedure: regenerative endodontic procedure using photo activated nanochitosan 2%

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

06

What researchers measure

Primary outcomes

  1. pain intensity assessed by numerical rating scale

    postoperative pain using numerical rating scale

    Time frame: 24 hours and 1 week after completion of the procedure

Secondary outcomes

  1. root development

    change of root length

    Time frame: 6 months, 1 year postoperative

  2. Apical foramen closure

    change in apical foramen diameter

    Time frame: 6 months, 1 year postoperative

  3. periapical bone healing

    change in the area of periapical lesion

    Time frame: 6 months, 1 year postoperative

07

Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2024; primary completion for Nov 2024, 1 month later.

Of 66 non-industry interventional studies with no phase under Dental Pulp Necrosis, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 35. This study's planned 1 month is below that.

Counting every sponsor, half of 67 studies reached it within 15 months; a quarter within 9 and three quarters within 31.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 13, 2024
First posted
Oct 8, 2024
StartEst.
Oct 11, 2024
Primary completionEst.
Nov 11, 2024
CompletionEst.
Apr 11, 2025
Last update
Oct 8, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 8, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06631885
Lead sponsor
Minia University
Responsible party
Mohammed abdelmawla mohammed (assisstant lecturer of endodontics, Minia University) — Principal investigator
First posted
Oct 8, 2024
Start date
Oct 11, 2024 (estimated)
Primary completion
Nov 11, 2024 (estimated)
Completion
Apr 11, 2025 (estimated)
Last update
Oct 8, 2024

Study contacts

Mohamed Abdelmawla, assisstant lecturer
Contact
dr.mohammed.abdelmawla@gmail.com
+20-1005757045

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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