Biological, Radiographic and Clinical Evaluation of Various Inter-Visit Root Canal Dressings in Retreatment Cases

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age21-45
SponsorAin Shams University

About this trial

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)

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Calcium Silicate Intracanal Medication

    Drug

    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.

  • Calcium Hydroxide Slurry mixed with Sodium Hypochlorite Intracanal Medication

    Drug

    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 (Ca(OH)2) Intracanal Medication

    Drug

    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.

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: Calcium Silicate Intracanal MedicationExperimental treatment 1 intervention
Group B: Calcium Hydroxide Slurry mixed with Sodium HypochloriteExperimental treatment 1 intervention
Group C: Calcium HydroxideActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Biological Evaluation of inflammatory marker (IL-1B)

IL-1B collected by periapical fluid sample using paper points and measured using ELISA.

Time frame
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

Pre-operative and post-operative limited FOV CBCT scans are taken to compare volumetric reduction in periapical lesion size.

Time frame
1 year between pre- and post-operative CBCT scans.

Other outcomes

1

Clinical Evaluation using Pain Score (Visual Analogue Scale)

evaluation of pain score using Visual Analogue Scale on a scale of 0-10 with 0 representing no pain and 10 representing the most severe pain (subjective)

Time frame
Pre-operative and Post-operative at 6, 24, 48, 72 hours and 1 week intervals

Sponsors and contacts

Click on the lead sponsor to view all of their trials.