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Clinical Efficacy of AH Plus Bioceramic Sealer

Primary Purpose

Root Canal Infection, Periapical Periodontitis, Periapical Diseases

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Kuwait
Study Type
Interventional
Intervention
AH Plus Bioceramic Sealer
AH Plus Sealer (resin-based)
Sponsored by
Ministry of Health, Kuwait
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Root Canal Infection

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Participants must be 21-65 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 first 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 Exclusion Criteria: 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 second/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

Sites / Locations

  • Jaber Al-Ahmed Dental Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SBO with AH Plus Bioceramic Sealer

WVC with resin-based AH Plus Sealer

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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).

Secondary Outcome Measures

Full Information

First Posted
February 27, 2023
Last Updated
October 2, 2023
Sponsor
Ministry of Health, Kuwait
Collaborators
Kuwait Institute for Medical Specialization
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1. Study Identification

Unique Protocol Identification Number
NCT05763420
Brief Title
Clinical Efficacy of AH Plus Bioceramic Sealer
Official Title
Clinical Efficacy of AH Plus Bioceramic Sealer in Root Canal Treatment of Molar Teeth: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
August 7, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ministry of Health, Kuwait
Collaborators
Kuwait Institute for Medical Specialization

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Calcium silicate sealers are used in endodontics because of their biocompatibility, bioactive properties and fluid-tight seal that forms a chemical bond with root canal dentine. In vitro and retrospective studies have shown promising results. However, to date, there is a lack of prospective and well-controlled studies. Aims and objectives: To compare the clinical outcome of SBO with WVC in primary root canal treatment. To compare the radiographic outcome of SBO with WVC in primary root canal treatment using periapical radiography (PA) and cone-beam computed tomography (CBCT). Materials and Methods: Patients who are referred for primary root canal treatment of molar teeth at Jaber Al-Ahmed Dental Center and fulfil the inclusion/exclusion criteria of the study will be included. Informed consent will be obtained from all participants. Preoperative PA and CBCT scans will be taken. Upon completion of root canal instrumentation, the participants will be randomly allocated to either Group A: SBO or Group B: WVC. The participants will be blinded to the type of treatment received and the clinician will only be informed of the obturation method once the canals are ready for obturation. All teeth will then be restored definitively. The participants will be recalled after 1 year for clinical and radiographic assessment using PA and CBCT scans. The participants will then be followed-up annually for up to 4 years. Statistical analysis will be performed. The design of the study will conform to the CONSORT statement. The study will be conducted in accordance with the Declaration of Helsinki, and ethical approval has been granted by the local health authority (ID: 2291). Statistical and Analytical Plans: Sample size estimation for the treatment outcome was performed using PASS 2019 computer software, utilizing information from previous studies on healing outcome after primary root canal treatment. For a two independent-samples t-test of proportions, at a power of 80% and a 5% significance level for a two-tailed test, detecting a 10% difference in healing rate required a sample size of 148 teeth. Adjusting for a dropout rate of 30%, the required sample size will be 212 teeth. The outcome at a specific time-point (12 months) will be a primary response variable in analysis. Outcome will be the dependent variable in logistic regression models with different predictor variables: age, sex, periapical status, preoperative pain, patency, apical size, root filling quality and sealer used. Two-way interactions between factors will also be assessed. Expected outcome (Null Hypothesis): No significant difference will be found between the two groups in clinical and radiographic outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Root Canal Infection, Periapical Periodontitis, Periapical Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Permuted block randomization using a block size of 4 will be used to randomly select 212 participants (106 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.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
212 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SBO with AH Plus Bioceramic Sealer
Arm Type
Experimental
Arm Description
The teeth will be obturated using a single cone technique with AH Plus Bioceramic Sealer.
Arm Title
WVC with resin-based AH Plus Sealer
Arm Type
Active Comparator
Arm Description
The teeth will be obturated using warm vertical compaction with resin-based AH Plus Sealer.
Intervention Type
Device
Intervention Name(s)
AH Plus Bioceramic Sealer
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
AH Plus Sealer (resin-based)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Assessment of radiographic healing with cone beam computed tomography (CBCT) scans using Estrela's PAI (periapical index)
Description
Estrela's PAI based on CBCT will be used in logistic regression models with different predictor variables.
Time Frame
Change from baseline periapical lesion size at 12 months
Title
Assessment of clinical outcome by assessing the resolution/persistence/development of clinical signs and symptoms
Description
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).
Time Frame
Change from baseline at 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Participants must be 21-65 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 first 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 Exclusion Criteria: 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 second/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
Facility Information:
Facility Name
Jaber Al-Ahmed Dental Center
City
Janūb As Surrah
State/Province
Hawalli Governate
ZIP/Postal Code
00000
Country
Kuwait

12. IPD Sharing Statement

Plan to Share IPD
No

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Clinical Efficacy of AH Plus Bioceramic Sealer

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