Clinical Efficacy of AH Plus Bioceramic Sealer

NCT05763420 | Enrolling By Invitation

• 1 other identifier: 2291
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to assess the efficacy and outcome of sealer-based obturation (SBO) using a new calcium silicate sealer in comparison with warm vertical compaction (WVC) using a resin-based sealer, which is the current gold standard.

Conditions

Root Canal Infection; Periapical Periodontitis; Periapical Diseases

Outcome Measures

Primary Outcomes (2)

• Assessment of radiographic healing with cone beam computed tomography (CBCT) scans using Estrela's PAI (periapical index)

  Estrela's PAI based on CBCT will be used in logistic regression models with different predictor variables.

  Change from baseline periapical lesion size at 12 months

• Assessment of clinical outcome by assessing the resolution/persistence/development of clinical signs and symptoms

  The examiner will label the teeth as having a normal clinical outcome (absence of pain, swelling and other symptoms, no sinus tract, no loss of function) or showing signs and symptoms clinical outcome (the tooth is associated with signs and/or symptoms of infection).

  Change from baseline at 12 months

Study Arms (2)

SBO with AH Plus Bioceramic Sealer

EXPERIMENTAL

The teeth will be obturated using a single cone technique with AH Plus Bioceramic Sealer.

Device: AH Plus Bioceramic Sealer

WVC with resin-based AH Plus Sealer

ACTIVE COMPARATOR

The teeth will be obturated using warm vertical compaction with resin-based AH Plus Sealer.

Device: AH Plus Sealer (resin-based)

Interventions

AH Plus Bioceramic Sealer DEVICE

A bioactive, calcium silicate-based sealer will be used in combination with the core root canal filling material (gutta-percha). It's premixed and is dispensed in the root canal via a fine disposable syringe.

SBO with AH Plus Bioceramic Sealer

AH Plus Sealer (resin-based) DEVICE

A resin-based sealer will be used in combination with the core root canal material (gutta-percha). It consists of two pastes that are mixed together in equal amounts prior to application.

WVC with resin-based AH Plus Sealer

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must be 18-65 years of age at the time of recruitment
• Participants must have a classification of I or II on the American Society of Anesthesiologists (ASA) physical status classification system
• Participants must not have known allergies to any materials used in the study
• Participants must agree to participate in the study by signing a consent form
• Participants must have good oral hygiene
• Maxillary and mandibular permanent molar teeth that require primary root canal treatment will be included
• The teeth must be restorable and have fully formed roots with no advanced periodontal disease

You may not qualify if:

• ASA classification of III or more
• Pregnant or breastfeeding women
• Patients who are unable to give consent
• Patients who have advanced periodontal disease or teeth with more than 5mm probing
• Anterior, premolar and third molar teeth
• Teeth whose apices were over-enlarged at the time of pulp extirpation
• Teeth with broken instruments
• Teeth with blocked or non-negotiable canals
• Teeth with iatrogenic perforations
• Teeth with incomplete root formation
• Teeth with internal or external root resorption
• Teeth that have a poor restorative prognosis
• Teeth that require posts or extensive prosthetic rehabilitation
• Teeth with cracks
• Teeth that have been previously root-filled

Sponsors & Collaborators

• Ministry of Health, Kuwait: lead
• Kuwait Institute for Medical Specialization: collaborator

Study Sites (1)

Jaber Al-Ahmed Dental Center

Janūb as Surrah, Hawalli Governate, 00000, Kuwait

Location

MeSH Terms

Conditions

Periapical Periodontitis; Periapical Diseases

Condition Hierarchy (Ancestors)

Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants will be blinded to the type of treatment they will receive to reduce bias in the reporting of pain. Since it is not possible to blind the care providers, they will only be informed of the type of treatment once cleaning and shaping has been completed and the tooth is ready to be obturated. This will reduce care provider bias. Assessors will be blinded to the treatment option to reduce bias during the assessment of healing.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Specialist in Endodontics

Model Details: Permuted block randomization using a block size of 4 will be used to randomly select 136 participants (68 participants in each group). The Study Randomizer website (http://www.studyrandomizer.com) will be utilized to generate the randomization list and participants will be assigned to the selected treatment group accordingly.

Study Record Dates

• First Submitted: February 27, 2023
• First Posted: March 10, 2023
• Study Start: August 7, 2023
• Primary Completion: January 29, 2026
• Study Completion (Estimated): January 29, 2027
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

KU (1)