ASA Physical Status I, Intervention Studies, Intracanal Medication, Periapical Abscess, Retreatment
Conditions
Keywords
intracanal medication, retreatment, inflammatory marker, radiographic, pain score
Brief summary
The aim of this clinical trial is to evaluate anti-inflammatory effect of various intracanal medications: 1. Calcium Hydroxide Slurry mixed with 3% Sodium Hypochlorite 2. Calcium Silicate 3. Calcium Hydroxide In retreatment cases in terms of: 1. Biological Evaluation: Biomarker (IL 1B) 2. Radiographic Evaluation: CBCT 3. Clinical Evaluation: Pain Score (VAS)
Detailed description
Sixty patients presenting with failed root canal treated lower first molars with periapical lesion were included in this randomized controlled single-center clinical superiority trial with two parallel arms and randomly allocated to 3 equal groups (n = 20) according to the type of ICM used. Patients were randomly allocated to receive either Ca(OH)2 slurry that was prepared from pure Ca(OH)2 powder mixed with 3% NaOCl, calcium-silicate (Bio-C Temp) or calcium hydroxide (CH) as ICM. Teeth were instrumented using a rotary file system (M3 pro Gold) and irrigated with 3% NaOCl. Subsequently, the root canals were dressed with a Ca(OH)2 + NaOCl or calcium silicate (test groups) or Ca(OH)2 (control group). Periapical fluid samples were collected after accessing the root canal in the first visit and after the root canal dressing removal in the second visit 2 weeks later using paper point. Samples were transferred to the microbiology lab immediately and levels of pro-inflammatory marker (IL1B) were measured using a specific enzyme-linked immunosorbent assay (ELISA) immediately after the second visit to test the reduction in inflammatory marker level after intracanal medication usage. Also, preoperative and 12 months-postoperative radiographic evaluation by CBCT were obtained to measure volumetric reduction in lesion size using segmentation technique. And patients rated their pain pre-operatively and then after 6, 12, 24, 48, 72 h and 7 days using the VAS score. Clinical and radiographic follow-up evaluations were scheduled for 1 week, 1 month, 6 months and 12 months by examining the patient clinically using palpation and percussion tests and pain questionnaire and periapical digital radiographs to compare reduction in lesion size.
Interventions
DRUGCalcium Silicate Intracanal Medication
Calcium silicate-based bioceramic materials have gained attention for their bioactivity and biocompatibility, acting through hydration with calcium hydroxide release followed by hydroxyapatite formation that promotes healing. Bio-C Temp is an example, characterized by high calcium ion release, alkaline pH, adequate radiopacity, and good biocompatibility.
DRUGCalcium Hydroxide Slurry mixed with Sodium Hypochlorite Intracanal Medication
Combining calcium hydroxide with sodium hypochlorite (NaOCl) has been proposed. NaOCl provides rapid and potent antimicrobial and tissue-dissolving effects, while Ca(OH)₂ offers prolonged action. Both agents retain their properties when combined, and this combination may produce a synergistic effect that enhances disinfection and reduces chair time in two-visit treatment protocols.
Calcium hydroxide ICM being the most widely used due to its high alkalinity, antimicrobial properties, endotoxin neutralization, and ability to reduce periapical inflammation. It is applied as an aqueous mixture or polyethylene glycol-based paste and provides a slow but sustained antimicrobial effect. Despite their benefits, Ca(OH)₂ medicaments re limited by their solubility, susceptibility to tissue fluids, potential to weaken tooth structure over time, and reduced effectiveness against resistant microorganisms such as Candida Albicans and Enterococcus Faecalis.
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Intracanal medication (drug) approved by the FDA.
Eligibility
Sex/Gender
ALL
Age
21 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age: 21-45 years. 2. Medically free patients. (ASA Class 1) 3. Gender: males and females 4. Patients who are cooperative at operation and in attendance at scheduled follow-up visits. 5. Restorable root canal treated permanent lower first molars with periapical lesions. 6. Small (\<5 mm) or medium periapical lesion size (5-10 mm)
Exclusion criteria
1. Patients with a history of allergic reactions to any of the study materials. 2. Teeth that become non-restorable after complete caries excavation. 3. Teeth that have mobility or deep periodontal pockets. 4. Teeth with internal or external resorption.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biological Evaluation of inflammatory marker (IL-1B) | 1st sample is collected in the first visit after root canal filling removal while 2nd sample is collected after intracanal medication removal in the second visit. Both visits are 14 days apart. | IL-1B collected by periapical fluid sample using paper points and measured using ELISA. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic Evaluation using limited FOV CBCT | 1 year between pre- and post-operative CBCT scans. | Pre-operative and post-operative limited FOV CBCT scans are taken to compare volumetric reduction in periapical lesion size. |
Countries
Egypt
Contacts
CONTACTMerna Mamdouh Botros Billatos, Msc
Outcome results
None listed