Periapical Disease
Conditions
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
Interventions
DRUGnanocurcumin gel
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
DRUGCurcumin Gel
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
DRUGCiprofloxacin 500 mg +ibuprofen 400mg
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
DRUGMetapaste [calcium hydroxide paste (control group)]
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
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| healing of periapical lesion | 1 year | measured radiographically the periapical lesion volmetric changes by CBCT between preoperative and after1 year follow up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Egypt
Outcome results
None listed