Comparing the Effect of Different Intracanal Dressing on Failed Root Canal Treated Cases on Periapical Healing
- Conditions
- Periapical Disease
- Interventions
- Registration Number
- NCT06342830
- Lead Sponsor
- Ain Shams University
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 80
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ciprofloxacin 500 mg +Ibuprofen 400 mg Ciprofloxacin 500 mg +ibuprofen 400mg Ciprofloxacin 500 mg +ibuprofen 400mg powder +carboxymethyl cellulose 300 mg +distilled water to 10 ml Curcumin gel Curcumin Gel curcumin 250 mg powder + carboxymethyl cellulose 300mg+distilled water to 10ml calcium hydroxide Metapaste [calcium hydroxide paste (control group)] Metapaste Nanocurcumin gel . nanocurcumin gel 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
- Primary Outcome Measures
Name Time Method healing of periapical lesion 1 year measured radiographically the periapical lesion volmetric changes by CBCT between preoperative and after1 year follow up
- Secondary Outcome Measures
Name Time Method 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 Three samples S1 after removal of old root canal filling , S2 after mechanical Preparation , S3 after 7 days of placement of intracanal dressing measuring total bacterial count by colony forming unit each sample cultured and incubated for 24hours and bacterial counting measured
Interappointment Pain 6,12, 24, 48, 72 hours after 1st visit measured by Numerical Rating Scale (NRS) which is an 11-point scale consisting of numbers from 0 through 10 0 reading represents "no pain"
1- 3 readings represent "mild pain" 4- 6 readings represent "moderate pain" 7- 10 readings represent "severe pain" No or mild pain was considered as success while moderate or severe pain were regarded as failure.
Trial Locations
- Locations (1)
faculty of dentistry, Ain shams university
🇪🇬Cairo, Egypt