Regenerative Endodontics in Mature Necrotic Teeth

N/ANot Yet RecruitingNCT07584928

Suez Canal University60 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Necrotic Teeth With Chronic Apical Periodontitis

Eligibility

Sex: ALLMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

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. * 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 Exclusion Criteria: * 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

Outcomes

Primary Outcomes

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.

Time frame: 1 year follow up

Secondary Outcomes

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.