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

NCT04753138 | Completed

• 1 other identifier: Fahadmz
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (2)

• Comparison of the postoperative pain score

  1, 3 and 7 days postoperatively

• Comparison of the time required to complete obturation between the 2 groups

  Intra-operatively

Study Arms (2)

SBO with calcium silicate sealer

EXPERIMENTAL

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

Device: TotalFill Bioceramic Sealer

WVC with resin based sealer

ACTIVE COMPARATOR

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

Device: AH+ Sealer

Interventions

TotalFill Bioceramic Sealer 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.

SBO with calcium silicate sealer

AH+ Sealer 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.

WVC with resin based sealer

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kuwait Institute for Medical Specialization: lead
• Ministry of Health, Kuwait: collaborator
• Kuwait Foundation for the Advancement of Sciences: collaborator

Study Sites (1)

Specialized Dental Center

Kuwait City, Kuwait

Location

Related Publications (1)

• Alzoubi F, Alajmi S, Alkandari A, Alqahtani S, Alanezi A, Setzer FC. Post-operative pain in non-surgical root canal treatment after sealer-based obturation versus warm vertical compaction: A randomized clinical trial. Int Endod J. 2024 Sep;57(9):1168-1179. doi: 10.1111/iej.14102. Epub 2024 May 30.

  PMID: 38813933 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Fahad Alzoubi, M.Endo

  Kuwait Board of Endodontics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair of Faculty of Dentistry

Model Details: 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.

Study Record Dates

• First Submitted: January 26, 2021
• First Posted: February 15, 2021
• Study Start: February 24, 2021
• Primary Completion: December 3, 2023
• Study Completion: December 3, 2023
• Last Updated: January 3, 2024

Record last verified: 2023-12

Locations

KU (1)