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

NCT03732170 | Active Not Recruiting

• 1 other identifier: 2018/00390
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

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.

Conditions

Root Canal Obturation

Outcome Measures

Primary Outcomes (1)

• Change in the status of periapical lesion size

  Proportion z-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).

  comparison of the periapical lesion size at baseline, 6 month and 12 month

Secondary Outcomes (1)

• Comparison of the pain score of post-op pain

  Day 1, Day 3 and Day 7 post treatment

Study Arms (2)

TotalFill® Bioceramic sealer

EXPERIMENTAL

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.

Device: TotalFill® Bioceramic sealer

AH plus® sealer

ACTIVE COMPARATOR

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.

Device: AH plus® sealer

Interventions

TotalFill® Bioceramic sealer DEVICE

The participant will be treated with TotalFill® Bioceramic sealer.

TotalFill® Bioceramic sealer

AH plus® sealer DEVICE

The participant will be treated with AH plus® sealer.

AH plus® sealer

Eligibility Criteria

• Age: 21 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National University Hospital, Singapore: lead

Study Sites (1)

National University Hospital, Singapore

Singapore, 119085, Singapore

Location

Study Officials

• Victoria Yu, PhD

  National University Hosptial, Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Blinding will be done to the assessors to reduce bias to healing assessment. As well, participants won't know which treatment they are undergoing.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Study subject (tooth) will be randomized in a 1:1 allocation ratio between the two treatment groups.

Study Record Dates

• First Submitted: November 1, 2018
• First Posted: November 6, 2018
• Study Start: August 13, 2018
• Primary Completion: June 30, 2019
• Study Completion (Estimated): June 30, 2026
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

SG (1)