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
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