Comparing the Effect of Different Intracanal Dressing on Failed Root Canal Treated Cases on Periapical Healing

Ain Shams University

Status and phase: Completed; Phase 2

Conditions: Periapical Disease

Treatments: Drug: Ciprofloxacin 500 mg +ibuprofen 400mg; Drug: Curcumin Gel; Drug: Metapaste [calcium hydroxide paste (control group)]; Drug: nanocurcumin gel

Study type: Interventional

Funder types: Other

Identifiers

NCT06342830

End 20-05 P

Details and patient eligibility

About

The goal of this clinical trial is to compare the effects of different intracanal medication between endodontic retreatment visits in previously failed root canal treatment patients (single root canal anteriors or premolars teeth). The main question it aims to answer are:

• Is natural and synthetic intracanal Medicament effective in reducing or complete healing of Periapical lesions or not? the researchers will compare the effect of different intracanal dressing including:
• nanocurcumin gel
• curcumin gel
• ciprofloxacin +ibuprofen gel
• calcium hydroxide Paste as control group in between the endodontic retreatment visits to see if these medicaments work well on periapical lesion healing this outcome measured by Cone beam CT at base and after 1 year follow up period

Enrollment: 60 patients

Sex: All

Ages: 20 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Medically free Patients
• both sex includes male and females
• Patients age between 20-60
• Patients agreement positively to share in the study
• patient able to sign informed consent
• on clinical and radiographic examinations, the included teeth maxillary and mandibular single root canal anteriors or premolars suffering from failed endodontic treatment with periapical lesion

Exclusion criteria

• badly broken down teeth indicated for extraction or with difficult isolation
• teeth with former procedural errors as ledge, perforation or instrument separation
• Medically compromised patients
• patients with history of receiving antibiotics within a month before starting study
• periodontally affected teeth by pocket depth & > 4mm

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 4 patient groups

Nanocurcumin gel .

Experimental group

Description:

Preparation Method: Olive oil (5%), surfactant (Tween 80 (8%)) and co-surfactant (PEG 400 (2%)) were used as excipients and their selection was based on the solubility of curcumin. A high-energy ultrasonication techniquewas used to prepare the Cur-NE. Curcumin (0.3%) was dissolved in oil /surfactant/ co-surfactant mixture and stirred till obtaining clear solution. The mixture was microtitrated with distilled water (85 %) to achieve a coarse emulsion. A 20 kHz ultrasonic processor was used for the production of the desired nano-emulsion. Gel Preparation: 0.4gm of Carboxymethyl cellulose (Loba CHIME, india) was sprinkled gently and gradually over the solution of Cur NE 0.3% under mild temperature with vigorous stirring to get homogenous gel

Treatment:

Drug: nanocurcumin gel

Curcumin gel

Experimental group

Description:

curcumin 250 mg powder + carboxymethyl cellulose 300mg+distilled water to 10ml

Treatment:

Drug: Curcumin Gel

Ciprofloxacin 500 mg +Ibuprofen 400 mg

Experimental group

Description:

Ciprofloxacin 500 mg +ibuprofen 400mg powder +carboxymethyl cellulose 300 mg +distilled water to 10 ml

Treatment:

Drug: Ciprofloxacin 500 mg +ibuprofen 400mg

calcium hydroxide

Active Comparator group

Description:

Metapaste

Treatment:

Drug: Metapaste [calcium hydroxide paste (control group)]