Immature TeethNCT06631885
Efficacy of Integrated Nano-technology in Revascularization of Immature Necrotic Teeth
A study testing regenerative endodontic procedure using blood clot according to AAE and regenerative endodontic procedure using photo activated nanochitosan 2% in people with Immature Teeth and Necrotic Pulp, run by Minia University.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Immature Teeth, Necrotic Pulp
- What is being tested?
- regenerative endodontic procedure using blood clot according to AAE and regenerative endodontic procedure using photo activated nanochitosan 2%
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 11 Oct 2024to 11 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Efficacy of Integrated Nano-technology in the Irrigation Protocol of Revascularization Technique In Immature Necrotic Teeth (Randomized Clinical Trial)
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.
- Conditions
- Immature Teeth, Necrotic Pulp
- Being tested
- regenerative endodontic procedure using blood clot according to AAE, regenerative endodontic procedure using photo activated nanochitosan 2%
- Keywords
- regenerative endodontic procedure
- Medical subject headings
- Dental Pulp Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
regenerative endodontic procedure using blood clot according to AAEProcedure or surgery
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 or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| control group: using AAE protocol | Active comparator | revascularization using blood clot according to the standardized protocol of the American association of endodontics Receives: Procedure: regenerative endodontic procedure using blood clot according to AAE |
| test group | Experimental | diode laser will be used to activate photosensitized nano chitosan 2% for canal disinfection instead of NaOCl in the first visit of revascularization protocol Receives: Procedure: regenerative endodontic procedure using photo activated nanochitosan 2% |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain intensity assessed by numerical rating scale
postoperative pain using numerical rating scale
Measured: 24 hours and 1 week after completion of the procedure
Secondary outcomes (3)
root development
change of root length
Measured: 6 months, 1 year postoperative
Apical foramen closure
change in apical foramen diameter
Measured: 6 months, 1 year postoperative
periapical bone healing
change in the area of periapical lesion
Measured: 6 months, 1 year postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start11 Oct 2024 (estimated)
- Primary completion11 Nov 2024 (estimated)
- Study completion11 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immature TeethStudies of the same condition, open and under way.
- More trials run by Minia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed abdelmawla mohammed, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06631885
- Sponsor's protocol ID
- (586/2022)
- Status last verified
- Oct 2024
- First submitted
- 13 Sep 2024
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Integrated Nano-technology in the Irrigation Protocol of Revascularization Technique In Immature Necrotic Teeth (Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT06631885
- Acronym / sponsor ID
- (586/2022)
- Conditions
- Immature Teeth, Necrotic Pulp
- Keywords
- regenerative endodontic procedure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 11 Oct 2024 (estimated)
- Primary completion
- 11 Nov 2024 (estimated)
- Study completion
- 11 Apr 2025 (estimated)
- First posted
- 8 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group: using AAE protocol | Active comparator | Procedure: regenerative endodontic procedure using blood clot according to AAErevascularization using blood clot according to the standardized protocol of the American association of endodontics |
| test group | Experimental | Procedure: 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- o Immature necrotic maxillary incisor with open apex greater than 1 mm.
Key exclusion criteria (4 listed)
- o Non-restorable teeth.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| regenerative endodontic procedure using blood clot according to AAEregenerative 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 | Procedure or surgery | control group: using AAE protocol |
| 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 | Procedure or surgery | test group |
Primary outcome
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
3 secondary outcomes
root development
Time frame: 6 months, 1 year postoperative
Apical foramen closure
Time frame: 6 months, 1 year postoperative
periapical bone healing
Time frame: 6 months, 1 year postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing regenerative endodontic procedure using blood clot according to AAE and regenerative endodontic procedure using photo activated nanochitosan 2% in people with Immature Teeth and Necrotic Pulp, run by Minia University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Abdelmawla, assisstant lecturer (+20-1005757045, dr.mohammed.abdelmawla@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain intensity assessed by numerical rating scale (time frame: 24 hours and 1 week after completion of the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.