Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2025-12-26 @ 3:05 AM
Study NCT ID:
NCT05763420
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-11-14
First Post:
2023-02-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Efficacy of AH Plus Bioceramic Sealer
Sponsor:
Ministry of Health, Kuwait
Organization:
Study Overview
Official Title:
Clinical Efficacy of AH Plus Bioceramic Sealer in Root Canal Treatment of Molar Teeth: A Randomized Controlled Trial
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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, bioactivity, and their ability to form a hydroxyapatite-mediated interfacial bond with root canal dentine. Although in vitro and retrospective clinical studies have reported promising findings, there remains a lack of prospective, well-controlled trials evaluating their clinical and radiographic performance.
Aims and Objectives:
1. To compare the clinical outcome of single-cone bioceramic obturation (SBO) with warm vertical compaction (WVC) in primary root canal treatment.
2. To compare the radiographic outcome of SBO and WVC using periapical (PA) radiographs and cone-beam computed tomography (CBCT).
Materials and Methods:
Patients referred for primary root canal treatment of molar teeth at Jaber Al-Ahmed Dental Center who fulfil the inclusion and exclusion criteria will be invited to participate. Written informed consent will be obtained from all participants.
Preoperative PA radiographs and CBCT scans will be taken. After completion of root canal instrumentation, participants will be randomly allocated to either Group A: SBO or Group B: WVC. Participants will be blinded to the obturation technique. Allocation will remain concealed until canals are ready for obturation, at which time the treating clinician will be informed of the assigned method.
All teeth will receive definitive restorations following obturation. Participants will be recalled at 12 months for clinical and radiographic evaluation using PA radiographs and CBCT, and will subsequently be followed annually for up to 4 years.
The study will conform to the CONSORT statement and will be conducted in accordance with the Declaration of Helsinki. Ethical approval has been granted by the local health authority (ID: 2291).
Statistical and Analytical Plan:
Sample size estimation for the primary healing outcome was performed using PASS (NCSS, Kaysville, UT, USA). Burns et al. (2022) reported pooled healing rates of approximately 92-93% under loose criteria and 82% under strict criteria in primary NSRCT, indicating that reductions on the order of 10-12 percentage points are clinically meaningful. Based on these data, an absolute 12% difference (0.99 vs 0.87) was considered clinically important.
Using a two-sided test comparing two independent proportions, with 80% power and 5% significance level, detecting this 12% absolute difference required 108 teeth (54 per group). Accounting for a 30% anticipated loss to follow-up, the required sample size is 156 teeth (78 per group).
Healing at 12 months will serve as the dependent variable in logistic regression models. Predictor variables will include age, sex, preoperative status, presence of apical periodontitis, preoperative pain, patency, apical preparation size, root filling quality, and sealer type. Two-way interactions will be assessed. Analyses will follow the intention-to-treat principle.
Null Hypothesis:
Hâ‚€: There is no difference between SBO and WVC in clinical or radiographic healing outcomes at 12 months.
Aims and Objectives:
1. To compare the clinical outcome of single-cone bioceramic obturation (SBO) with warm vertical compaction (WVC) in primary root canal treatment.
2. To compare the radiographic outcome of SBO and WVC using periapical (PA) radiographs and cone-beam computed tomography (CBCT).
Materials and Methods:
Patients referred for primary root canal treatment of molar teeth at Jaber Al-Ahmed Dental Center who fulfil the inclusion and exclusion criteria will be invited to participate. Written informed consent will be obtained from all participants.
Preoperative PA radiographs and CBCT scans will be taken. After completion of root canal instrumentation, participants will be randomly allocated to either Group A: SBO or Group B: WVC. Participants will be blinded to the obturation technique. Allocation will remain concealed until canals are ready for obturation, at which time the treating clinician will be informed of the assigned method.
All teeth will receive definitive restorations following obturation. Participants will be recalled at 12 months for clinical and radiographic evaluation using PA radiographs and CBCT, and will subsequently be followed annually for up to 4 years.
The study will conform to the CONSORT statement and will be conducted in accordance with the Declaration of Helsinki. Ethical approval has been granted by the local health authority (ID: 2291).
Statistical and Analytical Plan:
Sample size estimation for the primary healing outcome was performed using PASS (NCSS, Kaysville, UT, USA). Burns et al. (2022) reported pooled healing rates of approximately 92-93% under loose criteria and 82% under strict criteria in primary NSRCT, indicating that reductions on the order of 10-12 percentage points are clinically meaningful. Based on these data, an absolute 12% difference (0.99 vs 0.87) was considered clinically important.
Using a two-sided test comparing two independent proportions, with 80% power and 5% significance level, detecting this 12% absolute difference required 108 teeth (54 per group). Accounting for a 30% anticipated loss to follow-up, the required sample size is 156 teeth (78 per group).
Healing at 12 months will serve as the dependent variable in logistic regression models. Predictor variables will include age, sex, preoperative status, presence of apical periodontitis, preoperative pain, patency, apical preparation size, root filling quality, and sealer type. Two-way interactions will be assessed. Analyses will follow the intention-to-treat principle.
Null Hypothesis:
Hâ‚€: There is no difference between SBO and WVC in clinical or radiographic healing outcomes at 12 months.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: