Root Canal Treatment With TotalFill® Bioceramic Sealer and AH Plus® Sealer

NCT ID: NCT03732170

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 170 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-13
• Study Completion Date: 2026-06-30

Brief Summary

The study design is a double blinded randomized controlled trial and 170 subjects (teeth) , 85 in each of the 2 groups, will be enrolled from the patients at the NUH dental centre endodontic unit. The study aims to assess how the use of TotalFill® bioceramic sealer affects the healing outcome of apical periodontitis compared to a control AH plus®.

Conventional root canal treatment will be done during this study. Radiographs will be taken at each study visit during the study for root canal. The preoperative, postoperative and review clinical and radiographic data will be analysed.

Detailed Description

Randomization and Blinding Study subject (tooth) will be randomized in a 1:1 allocation ratio between the two treatment groups. Allocation will be by random permuted block and stratified by gender to enhance balance. Computer generated randomized allocation for each subject will be concealed in opaque envelope. The envelope will only be opened by the operator on the obturation visit of the enrolled patient and the randomization number assigned to them.

In the event that a patient has more than 1 tooth eligible for the study, only one tooth on left and/or right side of the mouth will be recruited for the study. Therefore, a patient could contribute a maximum of two teeth for this study (i.e. a maximum of one tooth on each side of the mouth). Selection of tooth will be done using computer generated randomization number.

Study Visits and Procedures After cleaning and shaping and the patients are deemed ready for obturation, the patients will be randomly assigned to one of the 2 groups for obturation using AH plus® or TotalFill® bioceramic sealer.

• The patients and the examiners will be blinded to the type of sealer used but it would not be possible to blind the operators.

b. Post Study Follow up and Procedures

• A follow up phone call will be made to collect the patient pain experience on day 1, day 3 and day 7 post treatment which they have recorded on their pain/discomfort diary.
• At the 6-month and 12-month review, patients will be examined for any clinical signs and symptoms and a review radiograph will be taken to assess the size of the periapical lesion.

c. Radiographic assessment

• All radiographs will be taken with a localising device to control for angulation and magnification.
• Calibrated measurement tools in the dental practice management software will be used to measure the diameter of the lesion across the longest diameter.

Statistical and Analytical Plans

a. General Considerations Intention-to-treat population is considered the main analysis population. The intention-to-treat population includes all subjects who were assigned a randomization number. Study subject's demographic and pre-operative characteristics will be summarized for each treatment group.

Conditions

Root Canal Obturation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

TotalFill® Bioceramic sealer

Intervention Type: DEVICE

The participant will be treated with TotalFill® Bioceramic sealer.

AH plus® 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.

Group Type: ACTIVE_COMPARATOR

AH plus® sealer

Intervention Type: DEVICE

The participant will be treated with AH plus® sealer.

Interventions

TotalFill® Bioceramic sealer

The participant will be treated with TotalFill® Bioceramic sealer.

Intervention Type: DEVICE

AH plus® sealer

The participant will be treated with AH plus® sealer.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• A preoperative periapical radiograph will be required for diagnosis.
• Subjects at least 21 years old.
• Medically healthy
• In a patient with multiple teeth requiring root canal treatment, only 1 tooth from each side will be included and selected at random.

Exclusion Criteria

• Patient below 21 years old
• Pregnant women.
• Patients with autoimmune diseases and uncontrolled diabetes.
• Teeth with periodontal probing depths of 5mm or more.
• Incomplete root formation that is detected radiographically.
• Cracked teeth
• Teeth are deemed to have poor restorative prognosis.
• Teeth with adjacent teeth on the same side that require root canal treatment

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National University Hospital, Singapore

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Victoria Yu, PhD

Role: PRINCIPAL_INVESTIGATOR

National University Hosptial, Singapore

Locations

National University Hospital, Singapore

Singapore, , Singapore

Countries

Singapore

Other Identifiers

2018/00390

Identifier Type: -

Identifier Source: org_study_id