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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Irrigation with 2.5% NaOCl & 17% EDTA | |
| Intervention 1: 1% Nanochitosan | Active Comparator | Irrigation with 1% nanochitosan |
|
| Intervention 2: 1% Nanochitosan & 17% EDTA | Active Comparator | Irrigation with 1% nanochitosan & 17% EDTA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention 1: 1% nanochitosan | Procedure | Irrigation with 1% nanochitosan |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of clinical success & healing of single visit regenerative endodontics in mature necrotic teeth with chronic apical periodontitis. | Clinical success will be evaluated via:
| 1 year follow up |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year follow up |
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Inclusion Criteria: -adult patients in the age range 18-40 years with necrotic mature anterior teeth with chronic apical periodontitis as evidenced by apical radiolucency.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sarah Hamed, M.D.Sc. in endodontics | Contact | +201012604389 | drsarahhamed25@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Suez Canal University | Ismailia | Egypt |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 12, 2026 | May 30, 2026 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D004492 | Edetic Acid |
| ID | Term |
|---|---|
| D005029 | Ethylenediamines |
| D003959 | Diamines |
| D011073 | Polyamines |
| D000588 | Amines |
| D009930 |
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| Intervention 2: 1% nanochitosan & 17% EDTA | Procedure | Irrigation with 1% nanochitosan & 17% EDTA |
|
| Organic Chemicals |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |