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NCT Number: NCT07641933

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

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)

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Key information

Age range

21 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Ain Shams University

Cairo, Egypt

Location status: Recruiting

Location contact

Ain Shams University

CONTACT

00201000397491

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Biological Evaluation of inflammatory marker (IL-1B)

    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.

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

Secondary outcomes

  1. Radiographic Evaluation using limited FOV CBCT

    Time frame: 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.

Other outcomes

  1. Clinical Evaluation using Pain Score (Visual Analogue Scale)

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

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Merna Mamdouh Botros Billatos, Msc

CONTACT

[email protected]

00201201579537

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Biological, Radiographic and Clinical Evaluation of Various Inter-Visit Root Canal Dressings in Retreatment Cases: A Randomized Controlled Clinical Trial

Acronym: RCT

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 11, 2026
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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