Clinical trial NCT04753138: Outcome of SBO With Calcium Silicate Sealer vs WVC With Resin Based Sealer
Official title: The Outcome of Non-surgical Root Canal Treatment Using Sealer-based Obturation With Calcium Silicate Sealer vs. Warm Vertical Compaction With AH+ Sealer. A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Root Canal Obturation
Root Canal Filling
Sealer-based Obturation
Randomized Clinical Trial
Postoperative Pain
Resin Based Sealer
Warm Vertical Compaction
Lead sponsor: Kuwait Institute for Medical Specialization
Sponsor class: OTHER_GOV
Collaborators: name: Ministry of Health, Kuwait
name: Kuwait Foundation for the Advancement of Sciences
First posted: 2021-02-15
Enrollment: 212
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

Brief summary: 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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Assessment of radiographic healing with periapical (PA) radiographs using Orstavik's PAI
timeFrame: Comparison of of periapical lesion size at baseline and 12 months
measure: Assessment of radiographic healing with Cone beam computed tomography (CBCT) scans using Estrela's PAI based on CBCT
timeFrame: Comparison of of periapical lesion size at baseline and 12 months
measure: Assessment of clinical outcome by assessing the resolution/persistence/development of clinical signs and symptoms
timeFrame: Comparison at baseline and 12 months
Secondary outcomes:
measure: Comparison of the postoperative pain score
timeFrame: 1, 3 and 7 days postoperatively
measure: Comparison of the time required to complete obturation between the 2 groups
timeFrame: Intra-operatively
Other outcomes:
Locations:
city: Kuwait
country: Kuwait
facility: Specialized Dental Center
Study officials:
affiliation: Kuwait Board of Endodontics
name: Fahad Alzoubi, M.Endo
role: PRINCIPAL_INVESTIGATOR
References: