Periapical PeriodontitisCSBSNCT07684014

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

A study testing Dia-Root Bio Sealer, Single cone (SC) Obturation technique and Warm Vertical compaction (WVC) technique in people with Periapical Periodontitis and Chronic Periapical Periodontitis, run by Ain Shams University at 1 site in Egypt.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record

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Trial 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. Postoperative healing. 2. Preoperative, postoperative pain and frequency of analgesic intake. Read more about this study

Who is it for?: Ages 20 to 50 years
Conditions the study is for: Periapical Periodontitis, Chronic Periapical Periodontitis, Periapical Abscess
What is being tested?: Dia-Root Bio Sealer, Single cone (SC) Obturation technique and Warm Vertical compaction (WVC) technique
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 63 participants
Where: 1 siteEgypt
Study dates: 29 Jul 2025to Dec 2028
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 50 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Faculty of Dentistry, Ain Shams University
Cairo

Other trials in Egypt

About this study

Official title: 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:

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

Read the 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.

Conditions: Periapical Periodontitis, Chronic Periapical Periodontitis, Periapical Abscess, Pulp Necrosis, Apical Periodontitis, Pulp Necrosis
Being tested: Dia-Root Bio Sealer, Single cone (SC) Obturation technique, Warm Vertical compaction (WVC) technique, Cold lateral condensation (CLC) technique
Keywords: Periapical periodontitis, Calcium silicate based sealer (CSBS), Dia-Root Bio Sealer, Obturation techniques, root canal obturation
Medical subject headings: Periapical Periodontitis, Periapical Abscess, Dental Pulp Necrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dia-Root Bio SealerDevice
Also called Calcium silicate-based sealer, CSBS, MTA-based bioceramic root canal 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.
Single cone (SC) Obturation techniqueProcedure or surgery
Also called Root canal compaction, Root filling techniques
Filling the prepared root canal with the master cone and the CSBS. Then cutting the excess gutta percha from the root canal orifice
Warm Vertical compaction (WVC) techniqueProcedure or surgery
Also called Root canal filling, Root canal obturation
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.
Cold lateral condensation (CLC) techniqueProcedure or surgery
Also called Root canal filling, Root canal obturation, Gold standard root canal filling 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.

Study groups in NCT07684014
Study group	Role	What they receive
Single cone (SC) technique group	Experimental	Conventional Root canal treatment followed by obturation with the Dia-Root Bio sealer using the Single cone technique Receives: 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 Receives: 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 Receives: Device: Dia-Root Bio Sealer; Procedure: Cold lateral condensation (CLC) technique

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 6 and 12 months postoperatively

Secondary outcomes (1)

Change in Postoperative Pain Intensity
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.
Measured: Preoperative (Baseline) and 72 hours postoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Jul 2025Dec 2028

First posted6 Jul 2026
Study start29 Jul 2025
Primary completionDec 2028 (estimated)
Study completionDec 2028 (estimated)

Why it stopped: Health conditions

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Periapical PeriodontitisStudies of the same condition, open and under way.
More trials run by Ain Shams UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 63 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07684014
Sponsor's protocol ID: 71226
Acronym: CSBS
Status last verified: Jun 2026
First submitted: 29 Jun 2026
Last updated: 7 Jul 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
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Effects of Different Activation Techniques on Antimicrobial Photodynamic Therapy in Apical Periodontitis
Apical Periodontitis, Endodontic Retreatment
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Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
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Not yet recruiting
PRP-Assisted Regenerative Endodontics Versus Conventional Root Canal Treatment in Mature Necrotic Teeth
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Influence of Continuous Rotation Versus Reciprocation Motion of MG3 Blue Rotary File on Postoperative Pain and Intracanal Bacterial Reduction of Teeth With Necrotic Pulps.
Necrotic Pulps With no Apical Periodontitis

All Periapical Periodontitis trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of New Heat-Resistant Calcium Silicate- Based Sealer Using Different Obturation Techniques (In-Vitro and In-Vivo Study)
ClinicalTrials.gov ID: NCT07684014
Acronym / sponsor ID: CSBS / 71226
Conditions: Periapical Periodontitis, Chronic Periapical Periodontitis, Periapical Abscess, Pulp Necrosis, Apical Periodontitis, Pulp Necrosis
Keywords: Periapical periodontitis, Calcium silicate based sealer (CSBS), Dia-Root Bio Sealer, Obturation techniques, root canal obturation
Study type: Interventional
Recruitment status: SuspendedReason stopped: Health conditions
Enrolment: 63 participants (actual)
Lead sponsor: Ain Shams UniversityUniversity, hospital or other
Study start: 29 Jul 2025 (actual)
Primary completion: Dec 2028 (estimated)
Study completion: Dec 2028 (estimated)
First posted: 6 Jul 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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:

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Single cone (SC) technique group	Experimental	Device: Dia-Root Bio Sealer, Procedure: Single cone (SC) Obturation techniqueConventional Root canal treatment followed by obturation with the Dia-Root Bio sealer using the Single cone technique
Warm vertical compaction (WVC) technique group	Experimental	Device: Dia-Root Bio Sealer, Procedure: Warm Vertical compaction (WVC) techniqueConventional Root canal treatment followed by obturation with the Dia-Root Bio sealer using the warm vertical compaction technique
Cold lateral compaction (CLC) technique group	Active comparator	Device: Dia-Root Bio Sealer, Procedure: Cold lateral condensation (CLC) techniqueConventional Root canal treatment followed by obturation with the Dia-Root Bio sealer using the cold lateral compaction technique

Who may qualify

Ages: 20 to 50 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (7 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Dia-Root Bio SealerAlso: Calcium silicate-based sealer, CSBS, MTA-based bioceramic root canal sealerThe 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.	Device	Cold lateral compaction (CLC) technique group, Single cone (SC) technique group, Warm vertical compaction (WVC) technique group
Single cone (SC) Obturation techniqueAlso: Root canal compaction, Root filling techniquesFilling the prepared root canal with the master cone and the CSBS. Then cutting the excess gutta percha from the root canal orifice	Procedure or surgery	Single cone (SC) technique group
Warm Vertical compaction (WVC) techniqueAlso: Root canal filling, Root canal obturationAfter 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.	Procedure or surgery	Warm vertical compaction (WVC) technique group
Cold lateral condensation (CLC) techniqueAlso: Root canal filling, Root canal obturation, Gold standard root canal filling techniqueAfter 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.	Procedure or surgery	Cold lateral compaction (CLC) technique group

Primary outcome

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

1 secondary outcome

Change in Postoperative Pain Intensity
Time frame: Preoperative (Baseline) and 72 hours postoperative

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
Individual participant dataSharing planned: Undecided

Related trials for Periapical Periodontitis

Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
Recruiting
Effects of Different Activation Techniques on Antimicrobial Photodynamic Therapy in Apical Periodontitis
Apical Periodontitis, Endodontic Retreatment
Not yet recruiting
Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
Post Operative Pain, Acute, Irreversible Pulpitis (Toothache)
Not yet recruiting
PRP-Assisted Regenerative Endodontics Versus Conventional Root Canal Treatment in Mature Necrotic Teeth
Pulp Necrosis, Apical Periodontitis
Not yet recruiting
Influence of Continuous Rotation Versus Reciprocation Motion of MG3 Blue Rotary File on Postoperative Pain and Intracanal Bacterial Reduction of Teeth With Necrotic Pulps.
Necrotic Pulps With no Apical Periodontitis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mohammed M Nagy, Professor study director

Faculty of Dentistry, Ain Shams University

Sara H Fahmy, Lecturer of Endodontics study chair

Faculty of Dentistry, Ain Shams University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: paused, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Success of healing and healing rate of the periapical lesion after one year (time frame: 6 and 12 months postoperatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07684014.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.