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

NCT06342830 | Completed Phase 2

• 1 other identifier: End 20-05 P
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Periapical Disease

Outcome Measures

Primary Outcomes (1)

• healing of periapical lesion

  measured radiographically the periapical lesion volmetric changes by CBCT between preoperative and after1 year follow up

  1 year

Secondary Outcomes (2)

• antibacterial effect (CFU)

  at first visit : S1 :baseline sample, S2 : sample immediately after chemomechanical procedure , at second visit S3: sample after 7 days of placement medication

• Interappointment Pain

  6,12, 24, 48, 72 hours after 1st visit

Study Arms (4)

Nanocurcumin gel .

EXPERIMENTAL

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

Drug: nanocurcumin gel

Curcumin gel

EXPERIMENTAL

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

Drug: Curcumin Gel

Ciprofloxacin 500 mg +Ibuprofen 400 mg

EXPERIMENTAL

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

Drug: Ciprofloxacin 500 mg +ibuprofen 400mg

calcium hydroxide

ACTIVE COMPARATOR

Metapaste

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

Interventions

nanocurcumin gel DRUG

firstly patient anesthetized, rubber dam isolation , disinfect the crown with 10%H2O2, saline then sodium hypochlorite solution 2.5% then 5% sodium thiosulphate solution to inhibit the effect of NaOHCl then removal of old coronal restoration, disinfection of pulp chamber by the same previous protocol removal of old root canal filling with gates glidden drills and H files , taken first sample S1 from canal with paper point after using saline wash and scrubbing the canal wall the paper points left for 1 min in the canal then preparation of canal with edge endo files till size 45 taper 0.4 and NaOHCL 2.5% between each file and the next finally 5% sodium thiosulphate to inhibit the antibacterial effect of sodium hypochlorite irrigation then saline irrigation and scrubbing the canal wall and placement of paper points for 1min to taken second sample S2, then dryness of canal and placement of nanocurcumin gel until shown fill the canal under magnification and by using lentulospirals

Nanocurcumin gel .

Curcumin Gel DRUG

firstly patient anesthetized, rubber dam isolation , disinfect the crown with 10%H2O2, saline then sodium hypochlorite solution 2.5% then 5% sodium thiosulphate solution to inhibit the effect of NaOHCl then removal of old coronal restoration, disinfection of pulp chamber by the same previous protocol removal of old root canal filling with gates glidden drills and H files , taken first sample S1 from canal with paper point after using saline wash and scrubbing the canal wall the paper points left for 1 min in the canal then preparation of canal with edge endo files till size 45 taper 0.4 and NaOHCL 2.5% between each file and the next finally 5% sodium thiosulphate to inhibit the antibacterial effect of sodium hypochlorite irrigation then saline irrigation and scrubbing the canal wall and placement of paper points for 1min to taken second sample S2, then dryness of canal and placement of curcumin gel until shown fill the canal under magnification and by using lentulospirals

Curcumin gel

Ciprofloxacin 500 mg +ibuprofen 400mg DRUG

firstly patient anesthetized, rubber dam isolation , disinfect the crown with 10%H2O2, saline then sodium hypochlorite solution 2.5% then 5% sodium thiosulphate solution to inhibit the effect of NaOHCl then removal of old coronal restoration, disinfection of pulp chamber by the same previous protocol removal of old root canal filling with gates glidden drills and H files , taken first sample S1 from canal with paper point after using saline wash and scrubbing the canal wall the paper points left for 1 min in the canal then preparation of canal with edge endo files till size 45 taper 0.4 and NaOHCL 2.5 % between each file and the next finally 5% sodium thiosulphate to inhibit the antibacterial effect of sodium hypochlorite irrigation then saline irrigation and scrubbing the canal wall and placement of paper points for 1min to taken second sample S2, then dryness of canal and placement of ciprofloxacin + ibuprofen gel until fill the canal under magnification and by using lentulospirals

Ciprofloxacin 500 mg +Ibuprofen 400 mg

Metapaste [calcium hydroxide paste (control group)] DRUG

firstly patient anesthetized, rubber dam isolation , disinfect the crown with 10%H2O2, saline then sodium hypochlorite solution 2.5% then 5% sodium thiosulphate solution to inhibit the effect of NaOHCl then removal of old coronal restoration, disinfection of pulp chamber by the same previous protocol removal of old root canal filling with gates glidden drills and H files , taken first sample S1 from canal with paper point after using saline wash and scrubbing the canal wall the paper points left for 1 min in the canal then preparation of canal with edge endo files till size 45 taper 0.4 and NaOHCL 2.5 % between each file and the next finally 5% sodium thiosulphate to inhibit the antibacterial effect of sodium hypochlorite irrigation then saline irrigation and scrubbing the canal wall and placement of paper points for 1min to taken second sample S2, then dryness of canal and placement of calcium hydroxide paste until fill the canal under magnification by using lentulospirals

calcium hydroxide

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

faculty of dentistry, Ain shams university

Cairo, 11512, Egypt

Location

MeSH Terms

Conditions

Periapical Diseases

Interventions

Ciprofloxacin; Ibuprofen; Control Groups

Condition Hierarchy (Ancestors)

Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Rawda MO Baghdady

  faculty of dentistry, zagazig university

  PRINCIPAL INVESTIGATOR

• sarah H Fahmy

  faculty of dentistry, Ain Shams university

  STUDY CHAIR

• karim M El Batouty

  faculty of dentistry, Ain Shams university

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: March 14, 2024
• First Posted: April 2, 2024
• Study Start: June 20, 2024
• Primary Completion: September 20, 2025
• Study Completion: October 31, 2025
• Last Updated: November 17, 2025

Record last verified: 2025-11

Locations

EG (1)