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

NCT07684014 | Suspended

• 1 other identifier: 71226
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Periapical Periodontitis; Periapical Abscess; Chronic Periapical Periodontitis; Pulp Necrosis; Pulp Necrosis, Apical Periodontitis

Keywords

Periapical periodontitis; Calcium silicate based sealer (CSBS); Dia-Root Bio Sealer; Obturation techniques; root canal obturation

Outcome Measures

Primary Outcomes (1)

• Success of healing and healing rate of the periapical lesion after one year

  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 Outcomes (1)

• Change in Postoperative Pain Intensity

  Preoperative (Baseline) and 72 hours postoperative

Study Arms (3)

Single cone (SC) technique group

EXPERIMENTAL

Conventional Root canal treatment followed by obturation with the Dia-Root Bio sealer using the Single cone technique

Device: Dia-Root Bio Sealer; Procedure: Single cone (SC) Obturation technique

Warm vertical compaction (WVC) technique group

EXPERIMENTAL

Conventional Root canal treatment followed by obturation with the Dia-Root Bio sealer using the warm vertical compaction technique

Device: Dia-Root Bio Sealer; Procedure: Warm Vertical compaction (WVC) technique

Cold lateral compaction (CLC) technique group

ACTIVE COMPARATOR

Conventional Root canal treatment followed by obturation with the Dia-Root Bio sealer using the cold lateral compaction technique

Device: Dia-Root Bio Sealer; Procedure: Cold lateral condensation (CLC) technique

Interventions

Dia-Root Bio Sealer DEVICE

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.

Also known as: Calcium silicate-based sealer, CSBS, MTA-based bioceramic root canal sealer

Cold lateral compaction (CLC) technique group; Single cone (SC) technique group; Warm vertical compaction (WVC) technique group

Single cone (SC) Obturation technique PROCEDURE

Filling the prepared root canal with the master cone and the CSBS. Then cutting the excess gutta percha from the root canal orifice

Also known as: Root canal compaction, Root filling techniques

Single cone (SC) technique group

Warm Vertical compaction (WVC) technique PROCEDURE

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.

Also known as: Root canal filling, Root canal obturation

Warm vertical compaction (WVC) technique group

Cold lateral condensation (CLC) technique PROCEDURE

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.

Also known as: Root canal filling, Root canal obturation, Gold standard root canal filling technique

Cold lateral compaction (CLC) technique group

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Dentistry, Ain Shams University

Cairo, Egypt

Location

MeSH Terms

Conditions

Periapical Periodontitis; Periapical Abscess; Dental Pulp Necrosis

Interventions

Methods; Root Canal Obturation

Condition Hierarchy (Ancestors)

Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Abscess; Suppuration; Infections; Dental Pulp Diseases; Tooth Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques; Root Canal Therapy; Endodontics; Dentistry

Study Officials

• Mohammed M Nagy, Professor

  Faculty of Dentistry, Ain Shams University

  STUDY DIRECTOR

• Sara H Fahmy, Lecturer of Endodontics

  Faculty of Dentistry, Ain Shams University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisstant Lecturer of Endodontics, Faculty of Dentistry, Ain Shams University

Study Record Dates

• First Submitted: June 29, 2026
• First Posted: July 6, 2026
• Study Start: July 29, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: July 7, 2026

Record last verified: 2026-06

Locations

EG (1)