Necrotic Teeth With Chronic Apical PeriodontitisNCT07584928
Regenerative Endodontics in Mature Necrotic Teeth
A study testing Intervention 1: 1% nanochitosan and Intervention 2: 1% nanochitosan & 17% EDTA in people with Necrotic Teeth With Chronic Apical Periodontitis, run by Suez Canal University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to learn if nanochitosan can achieve regeneration in mature necrotic teeth. It will also provide data about the healing potential \& postoperative pain after using different irrigation protocols. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Necrotic Teeth With Chronic Apical Periodontitis
- What is being tested?
- Intervention 1: 1% nanochitosan and Intervention 2: 1% nanochitosan & 17% EDTA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2026to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
None listed.
Who cannot join
- medically compromised patients, systemic conditions e.g. uncontrolled diabetes or those on immunosuppressive drugs.
- pregnant females
- patients with generalized chronic periodontitis, mobility, and deep pockets
- non-restorable teeth or teeth with open apices
- teeth where post is needed to be restored or with previous root canal therapy
- teeth with developmental anomalies, external and internal resorption
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Assessment of Clinical Success and Postoperative Pain of Mature Necrotic Teeth With Chronic Apical Periodontitis After Single Visit Regenerative Endodontics Using Different Irrigation Protocols: a Randomized Controlled Clinical Trial
The goal of this clinical trial is to learn if nanochitosan can achieve regeneration in mature necrotic teeth. It will also provide data about the healing potential \& postoperative pain after using different irrigation protocols. The main question it aims to answer are:
Does nanochitosan can demonstrate clinically successful outcome, minimize postoperative pain \& flare ups? What is the regenerative potential of mature necrotic teeth with chronic apical periodontitis? Is regeneration an alternative treatment modality for mature necrotic teeth with apical periodontitis? Researcher will compare the regenerative potential \& postoperative pain after using 2.5% NaOCl+ 17% EDTA, 1% nanochitosan \& 1% nanochitosan+17% EDTA to see if 1% nanochitosan alone or when used with 17% EDTA can enhance regeneration.
Read more
Participants' root canals will be:
Divided into 3 groups \&irrigated thoroughly by the different irrigation protocols (2.5% NaOCl+ 17% EDTA, 1% nanochitosan \& 1% nanochitosan+ 17% EDTA) Regenerative procedures will be done Clinical sensibility test \& radiographic changes will be evaluated at 6\&12 months follow up periods Detection of inflammatory mediators from GCF at 6 months follow up periods to be compared with its preoperative levels as a predictor for success or failure Assessment of postoperative pain using Numerical Rating Scale at 6, 12, 24 hours then daily for 7 days
- Being tested
- Intervention 1: 1% nanochitosan, Intervention 2: 1% nanochitosan & 17% EDTA
- Keywords
- Regeneration, Mature necrotic teeth, Nanochitosan, Inflammatory mediators
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention 1: 1% nanochitosanProcedure or surgery
Irrigation with 1% nanochitosan
Intervention 2: 1% nanochitosan & 17% EDTAProcedure or surgery
Irrigation with 1% nanochitosan \& 17% EDTA
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Irrigation with 2.5% NaOCl \& 17% EDTA |
| Intervention 1: 1% Nanochitosan | Active comparator | Irrigation with 1% nanochitosan Receives: Procedure: Intervention 1: 1% nanochitosan |
| Intervention 2: 1% Nanochitosan & 17% EDTA | Active comparator | Irrigation with 1% nanochitosan \& 17% EDTA Receives: Procedure: Intervention 2: 1% nanochitosan & 17% EDTA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of clinical success & healing of single visit regenerative endodontics in mature necrotic teeth with chronic apical periodontitis.
Clinical success will be evaluated via:
- Sensibility tests using cold test (Endo Ice) \& electric pulp tester at 6 \& 12 months follow up periods.
- Detection of molecular markers (inflammatory mediators) from the gingival crevicular fluid at 6 months follow up periods using ELISA.
- Radiographic analysis of the changes in size of periapical lesion using Cone Beam Computed Tomography (CBCT) at 6 \& 12 months follow up periods.
Measured: 1 year follow up
Secondary outcomes (1)
Postoperative pain assessment after single visit regenerative endodontics in mature necrotic teeth with chronic apical periodontitis.
Postoperative pain will be assessed using Numerical Rating Scale by reporting pain levels at 6, 12, 24 hours, then daily for 7 days and comparing it with pain levels prior to the procedures.
Measured: 1 year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Necrotic Teeth With Chronic Apical PeriodontitisStudies of the same condition, open and under way.
- 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07584928
- Sponsor's protocol ID
- 1123/2026
- Status last verified
- May 2026
- First submitted
- 30 Apr 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Clinical Success and Postoperative Pain of Mature Necrotic Teeth With Chronic Apical Periodontitis After Single Visit Regenerative Endodontics Using Different Irrigation Protocols: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07584928
- Acronym / sponsor ID
- 1123/2026
- Keywords
- Regeneration, Mature necrotic teeth, Nanochitosan, Inflammatory mediators
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 13 May 2026 (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.
The goal of this clinical trial is to learn if nanochitosan can achieve regeneration in mature necrotic teeth. It will also provide data about the healing potential \& postoperative pain after using different irrigation protocols. The main question it aims to answer are:
Does nanochitosan can demonstrate clinically successful outcome, minimize postoperative pain \& flare ups? What is the regenerative potential of mature necrotic teeth with chronic apical periodontitis? Is regeneration an alternative treatment modality for mature necrotic teeth with apical periodontitis? Researcher will compare the regenerative potential \& postoperative pain after using 2.5% NaOCl+ 17% EDTA, 1% nanochitosan \& 1% nanochitosan+17% EDTA to see if 1% nanochitosan alone or when used with 17% EDTA can enhance regeneration.
Participants' root canals will be:
Divided into 3 groups \&irrigated thoroughly by the different irrigation protocols (2.5% NaOCl+ 17% EDTA, 1% nanochitosan \& 1% nanochitosan+ 17% EDTA) Regenerative procedures will be done Clinical sensibility test \& radiographic changes will be evaluated at 6\&12 months follow up periods Detection of inflammatory mediators from GCF at 6 months follow up periods to be compared with its preoperative levels as a predictor for success or failure Assessment of postoperative pain using Numerical Rating Scale at 6, 12, 24 hours then daily for 7 days
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Irrigation with 2.5% NaOCl \& 17% EDTA |
| Intervention 1: 1% Nanochitosan | Active comparator | Procedure: Intervention 1: 1% nanochitosanIrrigation with 1% nanochitosan |
| Intervention 2: 1% Nanochitosan & 17% EDTA | Active comparator | Procedure: Intervention 2: 1% nanochitosan & 17% EDTAIrrigation with 1% nanochitosan \& 17% EDTA |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- medically compromised patients, systemic conditions e.g. uncontrolled diabetes or those on immunosuppressive drugs.
- pregnant females
- patients with generalized chronic periodontitis, mobility, and deep pockets
- non-restorable teeth or teeth with open apices
- teeth where post is needed to be restored or with previous root canal therapy
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 |
|---|---|---|
| Intervention 1: 1% nanochitosanIrrigation with 1% nanochitosan | Procedure or surgery | Intervention 1: 1% Nanochitosan |
| Intervention 2: 1% nanochitosan & 17% EDTAIrrigation with 1% nanochitosan \& 17% EDTA | Procedure or surgery | Intervention 2: 1% Nanochitosan & 17% EDTA |
Primary outcome
Assessment of clinical success & healing of single visit regenerative endodontics in mature necrotic teeth with chronic apical periodontitis.
Time frame: 1 year follow up
Clinical success will be evaluated via: 1. Sensibility tests using cold test (Endo Ice) \& electric pulp tester at 6 \& 12 months follow up periods. 2. Detection of molecular markers (inflammatory mediators) from the gingival crevicular fluid at 6 months follow up periods using ELISA. 3. Radiographic analysis of the changes in size of periapical lesion using Cone Beam Computed Tomography (CBCT) at 6 \& 12 months follow up periods.
1 secondary outcome
Postoperative pain assessment after single visit regenerative endodontics in mature necrotic teeth with chronic apical periodontitis.
Time frame: 1 year follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: Undecided
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention 1: 1% nanochitosan and Intervention 2: 1% nanochitosan & 17% EDTA in people with Necrotic Teeth With Chronic Apical Periodontitis, run by Suez Canal University at 1 site in Egypt.
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 0 inclusion and 6 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: opening soon, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah Hamed, M.D.Sc. in endodontics (+201012604389, drsarahhamed25@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of clinical success & healing of single visit regenerative endodontics in mature necrotic teeth with chronic apical periodontitis. (time frame: 1 year follow up). 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 3 Jun 2026; AzTrials last refreshed its copy on 26 Oct 2026.