Outcome of SBO With Calcium Silicate Sealer vs WVC With Resin Based Sealer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

212 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-24

Study Completion Date

2023-12-03

Brief Summary

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A single blinded randomized controlled trial. 212 subjects (teeth), 106 in each of the 2 groups will be recruited from the patients referred to Kuwait Board of Endodontics for primary root canal treatment. The aim is to compare the outcome of sealer-based obturation (SBO) with calcium silicate sealer versus warm vertical compaction (WVC) and resin based sealer.

Preoperative PA radiograph and CBCT will be taken. A 1 year follow up period will be arranged and another PA radiograph and CBCT will be taken. The preoperative, postoperative and review clinical and radiographic data will be analyzed

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Detailed Description

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Aims and Objectives

* To compare the clinical outcome of the SBO with WVC in non-surgical root canal treatment.
* To compare the radiographic outcome of the SBO with WVC in non-surgical root canal treatment using periapical radiographs and CBCT scans.
* To assess the difference in postoperative pain between the 2 groups.
* To assess the difference in the time required to complete the obturation between the 2 groups.

Materials and Methods

* Patients who are referred to the Kuwait Board of Endodontics for non-surgical root canal treatment and fulfil the inclusion/exclusion criteria of the study will be included
* Pre-operative periapical radiograph, CBCT scan and 11-point Numerical Rating Scale (NRS) will be taken.
* Upon completion of root canal instrumentation, the participants will be randomly allocated to either Group A: obturation using SCCS or Group B: obturation using 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 canal/canals are ready for obturation.
* All teeth will then be restored definitively.
* The participants will be contacted via telephone 1, 3 and 7 days post-treatment to report their NRS pain score.
* The participants will be recalled after 1 year for clinical and radiographic assessment using periapical radiograph and CBCT scan.
* 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.

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 initial endodontic therapy. For a two independent-samples t-test of proportions, at power of 80% and 5% significance level for two-tailed test, detecting a 10% difference of healing rate required a sample size of 148 teeth. Adjusting for a dropout rate of 30%, the required sample size was 212 teeth. The slightly high 30% dropout rate is anticipated because most of the patients we treat are non-Kuwaiti nationals and their presence in the country after 1 year is not guaranteed.

Conditions

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Root Canal Obturation Root Canal Filling Sealer-based Obturation Randomized Clinical Trial Postoperative Pain Resin Based Sealer Warm Vertical Compaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Permuted block randomization (of block size = only known to statistician) will be used to randomly select 212 subjects (106 subjects in each group). Statistical software (NCSS, LLC© ver. 2020) will be utilized to generate the randomization list and subjects will be assigned to the selected treatment group accordingly.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Participants will be blinded to the type of treatment they receive to reduce bias in the reporting of postoperative pain.

Since it is not possible to blind the care providers, they will only be informed of the type of treatment once full chemo-mechanical debridement has been completed and the tooth is ready to be obturated. This would reduce care provider bias.

Assessors will be blinded to the treatment option to reduce bias during the assessment of healing.

Study Groups

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SBO with calcium silicate sealer

The teeth will be obturated with the single cone technique and BC sealer

Group Type EXPERIMENTAL

TotalFill Bioceramic Sealer

Intervention Type DEVICE

It will be used in conjunction with TotalFill® bioceramic impregnated gutta percha points for the obturation of root canals. It is dispensed through a fine disposable syringe into the root canals during obturation.

WVC with resin based sealer

The teeth will be obturated with warm vertical compaction and AH+ sealer

Group Type ACTIVE_COMPARATOR

AH+ Sealer

Intervention Type DEVICE

It consists of 2 pastes that are mixed together in equal amounts before it is used in conjunction with gutta percha points for obturation during root canal treatment.

Interventions

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TotalFill Bioceramic Sealer

It will be used in conjunction with TotalFill® bioceramic impregnated gutta percha points for the obturation of root canals. It is dispensed through a fine disposable syringe into the root canals during obturation.

Intervention Type DEVICE

AH+ Sealer

It consists of 2 pastes that are mixed together in equal amounts before it is used in conjunction with gutta percha points for obturation during root canal treatment.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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
* All types of permanent teeth are included (incisors, canines, premolars \& molars)
* The teeth must be restorable and have fully formed roots with no advanced periodontal disease
* In the event that a patient has more than 1 tooth eligible for the study, only one tooth on the left and/or right side of the mouth will be selected at random. A maximum of 2 teeth per participant can be included in the study

Exclusion Criteria

* ASA classification of III or more
* Pregnant women
* Advanced periodontal disease or teeth with more than 5mm probing
* Teeth with incomplete root formation or root resorption
* Teeth with adjacent teeth that require RCT
* Previously root canal treated teeth
* Teeth with a history of trauma
* Teeth that have poor restorative prognosis
* Teeth requiring extensive prosthodontic rehabilitation
* Cracked teeth

Minimum Eligible Age

16 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes