Biological, Radiographic and Clinical Evaluation of Various Inter-Visit Root Canal Dressings in Retreatment Cases
RCT
1 other identifier
interventional
60
1 country
1
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
- 4.Biological Evaluation: Biomarker (IL 1B)
- 5.Radiographic Evaluation: CBCT
- 6.Clinical Evaluation: Pain Score (VAS)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jun 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2026
CompletedFirst Submitted
Initial submission to the registry
June 7, 2026
CompletedFirst Posted
Study publicly available on registry
June 11, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2027
June 12, 2026
June 1, 2026
1 year
June 7, 2026
June 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Biological Evaluation of inflammatory marker (IL-1B)
IL-1B collected by periapical fluid sample using paper points and measured using ELISA.
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.
Secondary Outcomes (1)
Radiographic Evaluation using limited FOV CBCT
1 year between pre- and post-operative CBCT scans.
Other Outcomes (1)
Clinical Evaluation using Pain Score (Visual Analogue Scale)
Pre-operative and Post-operative at 6, 24, 48, 72 hours and 1 week intervals
Study Arms (3)
Calcium Silicate Intracanal Medication
EXPERIMENTALCalcium silicate-based bioceramic Intracanal Medication as Bio C-Temp (Angelus)
Calcium Hydroxide Slurry mixed with Sodium Hypochlorite
EXPERIMENTALCalcium Hydroxide slurry mixed with 3% Sodium Hypochlorite
Calcium Hydroxide
ACTIVE COMPARATORCalcium Hydroxide Intracanal Medication (Control Group)
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- Age: 21-45 years.
- Medically free patients. (ASA Class 1)
- Gender: males and females
- Patients who are cooperative at operation and in attendance at scheduled follow-up visits.
- Restorable root canal treated permanent lower first molars with periapical lesions.
- Small (\<5 mm) or medium periapical lesion size (5-10 mm)
You may not qualify if:
- Patients with a history of allergic reactions to any of the study materials.
- Teeth that become non-restorable after complete caries excavation.
- Teeth that have mobility or deep periodontal pockets.
- Teeth with internal or external resorption.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ain Shams University
Cairo, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 7, 2026
First Posted
June 11, 2026
Study Start
June 1, 2026
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
August 1, 2027
Last Updated
June 12, 2026
Record last verified: 2026-06