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

Postoperative Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04753138
• Other study ID #: Fahadmz
• Status: Completed
• Phase: N/A
• Start date: February 24, 2021
• Est. completion date: December 3, 2023

Study information

• Verified date: December 2023
• Source: Kuwait Institute for Medical Specialization
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 212
• Est. completion date: December 3, 2023
• Est. primary completion date: December 3, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain
• Randomized Clinical Trial
• Root Canal Obturation

Intervention

Device:
• 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.
• 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.

Locations

Country	Name	City	State
Kuwait	Specialized Dental Center	Kuwait

Sponsors (3)

Lead Sponsor	Collaborator
Kuwait Institute for Medical Specialization	Kuwait Foundation for the Advancement of Sciences, Ministry of Health, Kuwait

Country where clinical trial is conducted

Kuwait, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of radiographic healing with periapical (PA) radiographs using Orstavik's PAI	Proportion t-test will be carried to compare the proportion of study subjects with improved apical lesion size between the two treatment groups. Odds ratio with 95% confidence interval will be reported. Logistic regression analysis adjusted for the stratification variables (gender) and other confounding factors (namely patency, extrusion of sealer or GP, short fill, voids, pre-op apical size, pre-op clinical symptoms and number of C&S visits). Orstavik's periapical index (PAI) will be used as the outcome measure	Comparison of of periapical lesion size at baseline and 12 months
Primary	Assessment of radiographic healing with Cone beam computed tomography (CBCT) scans using Estrela's PAI based on CBCT	Proportion t-test will be carried to compare the proportion of study subjects with improved apical lesion size between the two treatment groups. Odds ratio with 95% confidence interval will be reported. Logistic regression analysis adjusted for the stratification variables (gender) and other confounding factors (namely patency, extrusion of sealer or GP, short fill, voids, pre-op apical size, pre-op clinical symptoms and number of C&S visits). Estrela's (periapical index) PAI based on CBCT will be used as outcome measure	Comparison of of periapical lesion size at baseline and 12 months
Primary	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)	Comparison at baseline and 12 months
Secondary	Comparison of the postoperative pain score	11 point Numerical Rating Scale (NRS) will be used. The participants will be given an NRS sheet to complete. They will be asked to choose a number between 0 'No Pain' and 10 'Worst imaginable pain' that best represents your pain intensity.	1, 3 and 7 days postoperatively
Secondary	Comparison of the time required to complete obturation between the 2 groups		Intra-operatively