Evaluation of Bone Healing After Obturation Using Dia-Root Bio Sealer (CSBS) After Obturation Using Three Obturation Techniques (CSBS)

June 29, 2026 updated by: Omnia Saber, Ain Shams University

Evaluation of New Heat-Resistant Calcium Silicate- Based Sealer Using Different Obturation Techniques (In-Vitro and In-Vivo Study)

The study aims to evaluate the efficiency of using a Calcium silicate-based sealer (CSBS) with different obturation techniques in treating root canals with apical periodontitis in single visit.

Evaluating:

  1. Postoperative healing.
  2. Preoperative, postoperative pain and frequency of analgesic intake.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Detailed Description

Evaluation of Dia-Root Bio Sealer (CSBS) using the three known obturation techniques; Single cone (SC) technique, Warm vertical compaction (WVC) technique, and Cold lateral compaction (CLC) technique.

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Faculty of Dentistry, Ain Shams University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Medical condition: Medically free patients.
  • Age: Ranging from 20-50 years old
  • Gender: Male and female patients
  • Teeth: Patients with mandibular permanent mature molar(s) diagnosed with necrotic pulps and with apical periodontitis (asymptomatic, symptomatic apical periodontitis, or chronic periapical abscess), with at least one of the roots showing radiographic evidence of periapical lesion.
  • Preoperative radiographic (CBCT) lesion size should range from 2 - 4 mm.
  • Patients who fulfill these criteria, agree to participate, and sign the informed consent

Exclusion Criteria:

  • Participants with generalized periodontal disease, and those who are pregnant, breastfeeding, or have any systemic disease.
  • Teeth diagnosed with immature apices, root resorption, or non-restorable.
  • Patients in which the clinical assessment necessitates multiple-visits treatment, such as those with signs and symptoms of acute or diffuse infection.
  • Patients who had pre-treatment antibiotic therapy or analgesics and within 7 days.
  • Patients who fail to complete their final restoration postoperatively.
  • Patients who will refuse to sign the informed consent.
  • Root canals requiring apical preparation larger the #40.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single cone (SC) technique group
Conventional Root canal treatment followed by obturation with the Dia-Root Bio sealer using the Single cone technique
Device: Dia-Root Bio Sealer
The sealer will be delivered in the canals with the provided intracanal tips inserted three millimeters from the WL and back filling until the orifice. The pre-fitted master cone will be inserted with slight up and down motion before reaching the WL.
Other Names:
  • Calcium silicate-based sealer
  • CSBS
  • MTA-based bioceramic root canal sealer
Procedure: Single cone (SC) Obturation technique
Filling the prepared root canal with the master cone and the CSBS. Then cutting the excess gutta percha from the root canal orifice
Other Names:
  • Root canal compaction
  • Root filling techniques
Experimental: Warm vertical compaction (WVC) technique group
Conventional Root canal treatment followed by obturation with the Dia-Root Bio sealer using the warm vertical compaction technique
Device: Dia-Root Bio Sealer
The sealer will be delivered in the canals with the provided intracanal tips inserted three millimeters from the WL and back filling until the orifice. The pre-fitted master cone will be inserted with slight up and down motion before reaching the WL.
Other Names:
  • Calcium silicate-based sealer
  • CSBS
  • MTA-based bioceramic root canal sealer
Procedure: Warm Vertical compaction (WVC) technique
After placing the CSBS intside the RC, the cone will be packed down till 4 mm from the apex for 4 seconds cycles. Then the apical GP will be condensed using pluggers previously fitted inside the canal. Canals will be backfilled with 180C temperature setting. The tip will be placed into the root canal against the apical gutta-percha for 5 s before extruding the gutta-percha on increments. The middle and coronal thirds will be condensed using pre-fitted pluggers.
Other Names:
  • Root canal filling
  • Root canal obturation
Active Comparator: Cold lateral compaction (CLC) technique group
Conventional Root canal treatment followed by obturation with the Dia-Root Bio sealer using the cold lateral compaction technique
Device: Dia-Root Bio Sealer
The sealer will be delivered in the canals with the provided intracanal tips inserted three millimeters from the WL and back filling until the orifice. The pre-fitted master cone will be inserted with slight up and down motion before reaching the WL.
Other Names:
  • Calcium silicate-based sealer
  • CSBS
  • MTA-based bioceramic root canal sealer
Procedure: Cold lateral condensation (CLS) technique
After placing the CSBS inside the root canal, the master GP cone will be laterally condensed with a pre-selected spreader inserted 2-4 mm from the WL and accessory GP cone will be placed in the provided space by the spreader. This process will be repeated until 1 mm from the canal orifice. Excess GP will be cut at the orifice with a heat carrier and lightly packed vertically with a plugger.
Other Names:
  • Root canal filling
  • Root canal obturation
  • Gold standard root canal filling technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success of healing and healing rate of the periapical lesion after one year
Time Frame: 6 and 12 months postoperatively
Periapical bone healing will be evaluated using Cone Beam Computed Tomography (CBCT) images scored according to the CBCT Periapical Index (CBCT-PAI). Success is defined as a CBCT-PAI score of 0 (healthy) or a significant reduction in the volumetric size of the periapical radiolucency compared to the preoperative baseline
6 and 12 months postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Postoperative Pain Intensity
Time Frame: Preoperative (Baseline) and 72 hours postoperative
The change in patient-reported pain intensity from baseline. Pain is evaluated using a 0 to 100 mm Visual Analog Scale (VAS), where 0 represents 'no pain' and 100 represents 'the worst imaginable pain' Patients will be asked not to use analgesic medication after treatment until needed. If necessary, the patient will be instructed to record pain score before analgesic administration and record the dose and frequency of intake (by hour) of the analgesic and to submit this information after 72 h.
Preoperative (Baseline) and 72 hours postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Study Director: Mohammed M Nagy, Professor, Faculty of Dentistry, Ain Shams University
  • Study Chair: Sara H Fahmy, Lecturer of Endodontics, Faculty of Dentistry, Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 29, 2025

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

June 29, 2026

First Submitted That Met QC Criteria

June 29, 2026

First Posted (Actual)

July 6, 2026

Study Record Updates

Last Update Posted (Actual)

July 6, 2026

Last Update Submitted That Met QC Criteria

June 29, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 71226

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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