Regenerative Endodontics in Mature Necrotic Teeth

NCT07584928 | Not Yet Recruiting

• 1 other identifier: 1123/2026
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Necrotic Teeth With Chronic Apical Periodontitis

Keywords

Regeneration; Mature necrotic teeth; Nanochitosan; Inflammatory mediators

Outcome Measures

Primary Outcomes (1)

• 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. 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 year follow up

Secondary Outcomes (1)

• Postoperative pain assessment after single visit regenerative endodontics in mature necrotic teeth with chronic apical periodontitis.

  1 year follow up

Study Arms (3)

Control

NO INTERVENTION

Irrigation with 2.5% NaOCl \& 17% EDTA

Intervention 1: 1% Nanochitosan

ACTIVE COMPARATOR

Irrigation with 1% nanochitosan

Procedure: Intervention 1: 1% nanochitosan

Intervention 2: 1% Nanochitosan & 17% EDTA

ACTIVE COMPARATOR

Irrigation with 1% nanochitosan \& 17% EDTA

Procedure: Intervention 2: 1% nanochitosan & 17% EDTA

Interventions

Intervention 1: 1% nanochitosan PROCEDURE

Irrigation with 1% nanochitosan

Intervention 1: 1% Nanochitosan

Intervention 2: 1% nanochitosan & 17% EDTA PROCEDURE

Irrigation with 1% nanochitosan \& 17% EDTA

Intervention 2: 1% Nanochitosan & 17% EDTA

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• patients with good general health, without known systemic diseases or allergic reactions to any of the material used affecting healing outcome, with no sex predilection

You may not qualify if:

• 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

Sponsors & Collaborators

• Suez Canal University: lead

Study Sites (1)

Suez Canal University

Ismailia, Egypt

Location

MeSH Terms

Interventions

Edetic Acid

Intervention Hierarchy (Ancestors)

Ethylenediamines; Diamines; Polyamines; Amines; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids

Central Study Contacts

Sarah Hamed, M.D.Sc. in endodontics

CONTACT

+201012604389; drsarahhamed25@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2026
• First Posted: May 13, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 13, 2026

Record last verified: 2026-05

Locations

EG (1)