NCT07106307

Brief Summary

The aim of this clinical study is to evaluate the effect of root canal filling, which is the last stage of root canal treatment (RCT), on the post-operative pain level on single rooted permanent teeth with wide lesions with apical periodontitis, and the effect on the healing of the periapical tissue and lesion by comparing periapical radyography images, which was taken at the beginning and after one year.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
168

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 12, 2025

Completed
25 days until next milestone

First Posted

Study publicly available on registry

August 6, 2025

Completed
Last Updated

August 6, 2025

Status Verified

July 1, 2025

Enrollment Period

1.5 years

First QC Date

July 12, 2025

Last Update Submit

July 29, 2025

Conditions

Apical PeriodontitisPeriapical Lesion

Keywords

Apical PeriodontitisPeriapical HealingBioseramic sealerEpoxy Resin Based SealerWarm Vertical Compaction

Outcome Measures

Primary Outcomes (1)

  • Periapical Healing

    The primary outcome of this study is periapical healing. It will be assessed radiographically using standardized periapical images (taken with the parallel technique), captured preoperatively and at the 1-year follow-up, and evaluated using the Periapical Index (PAI) score by two blinded observers. The PAI score ranges from 1 (healthy periapical structures) to 5 (severe periodontitis).

    From end of treatment to 1 year

Secondary Outcomes (2)

  • Post Operative Pain İntensity

    From end of treatment to 6, 12, 18, 24, 48, and 72 hours; 7 days; and 1 month after root canal treatment

  • Post Operative Pain Intensity

    From end of treatment to 6, 12, 18, 24, 48, and 72 hours; 7 days; and 1 month after root canal treatment

Study Arms (4)

Cold lateral compaction with AH Plus (Epoxy Resin Based Sealer)

EXPERIMENTAL

Root canal obturation will be performed using the cold lateral compaction technique with AH Plus epoxy-resin based sealer.

Other: Epoxy Resin-Based SealerProcedure: Cold Lateral Compaction

Cold lateral compaction with AH Plus Bioceramic (Calcium Silicate Based Sealer)

EXPERIMENTAL

Root canal obturation will be performed using the cold lateral compaction technique with AH Plus Bioceramic sealer.

Other: Bioceramic SealerProcedure: Cold Lateral Compaction

Warm vertical compaction with AH Plus (Epoxy Resin Based Sealer)

EXPERIMENTAL

Root canal obturation will be performed using the warm vertical compaction technique with AH Plus epoxy-resin based sealer.

Procedure: Warm Vertical CompactionOther: Epoxy Resin-Based Sealer

Warm vertical compaction with AH Plus Bioceramic (Calcium Silicate Based Sealer)

EXPERIMENTAL

Root canal obturation will be performed using the warm vertical compaction technique with AH Plus Bioceramic sealer.

Other: Bioceramic SealerProcedure: Warm Vertical Compaction

Interventions

Bioceramic SealerOTHER

This intervention involves the use of Bioceramic Sealer during root canal obturation. The sealer will be combined with the cold lateral compaction or warm vertical compaction technique depending on the study arm.

Cold lateral compaction with AH Plus Bioceramic (Calcium Silicate Based Sealer)Warm vertical compaction with AH Plus Bioceramic (Calcium Silicate Based Sealer)
Warm Vertical CompactionPROCEDURE

Warm vertical obturation is performed using a heat delivery device, which thermosoftens gutta-percha and allows vertical compaction into the root canal system. This technique will be used in combination with either resin-based or bioceramic sealers, depending on the study group.

Warm vertical compaction with AH Plus (Epoxy Resin Based Sealer)Warm vertical compaction with AH Plus Bioceramic (Calcium Silicate Based Sealer)
Epoxy Resin-Based SealerOTHER

This intervention involves the use of an epoxy resin-based root canal sealer during root canal obturation. The material will be applied in combination with either cold lateral compaction or warm vertical compaction techniques, depending on the study group.

Cold lateral compaction with AH Plus (Epoxy Resin Based Sealer)Warm vertical compaction with AH Plus (Epoxy Resin Based Sealer)
Cold Lateral CompactionPROCEDURE

Cold lateral compaction is a root canal obturation technique in which a master gutta-percha cone is placed to working length and compacted laterally using a finger spreader. This method will be used in combination with either resin-based or bioceramic sealers, depending on the study group.

Cold lateral compaction with AH Plus (Epoxy Resin Based Sealer)Cold lateral compaction with AH Plus Bioceramic (Calcium Silicate Based Sealer)

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Single rooted anterior and premolar teeth with radiographically confirmed periapical lesions classified as Periapical Index (PAI) scores of 4 or 5 will be included in the analysis
  • Age between 18 and 60 years
  • Systemically healthy individuals
  • To be able to read and sign the informed consent form
  • Physical and mental fitness to undergo treatment
  • Willingness to attend all follow-up sessions

You may not qualify if:

  • Patients with systemic diseases classified as ASA III or higher
  • Presence of severe periodontal disease (probing depth \>4 mm)
  • Use of analgesics within the last 12 hours or antibiotics within the past month before the treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University Faculty of Dentistry

Istanbul, Esenler, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periapical Periodontitis

Interventions

epoxy resin-based root canal sealer

Condition Hierarchy (Ancestors)

Periapical DiseasesJaw DiseasesStomatognathic DiseasesPeriodontal DiseasesMouth DiseasesPeriodontitis

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Department of Endodontics, Medipol University

Study Record Dates

First Submitted

July 12, 2025

First Posted

August 6, 2025

Study Start

November 1, 2023

Primary Completion

May 15, 2025

Study Completion

May 15, 2025

Last Updated

August 6, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

All collected individual participant data (IPD), including all IPD that underlie the results reported in the publication

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Data will be shared starting 6 months after publication.
Access Criteria
Qualified researchers may request access to all de-identified individual participant data (IPD) and study protocols. Access will be granted upon reasonable request by contacting the corresponding author via email and after signing a data sharing agreement

Locations

TU(1)