Effect of NeoSEALER FLO and AH Plus Resin Sealer on Postoperative Pain and Healing of Periapical Lesions | NCT07785973 | Trialant

RecruitingInterventionalNot ApplicableUpdated Aug 25, 2026

Effect of NeoSEALER FLO and AH Plus Resin Sealer on Postoperative Pain and Healing of Periapical Lesions

Effect of NeoSEALER FLO and AH Plus Resin Sealer on Postoperative Pain and Healing of Periapical Lesions: A Randomized Clinical Study

Overview

Key facts that identify this study and show where it stands today.

ClinicalTrials.gov ID: NCT07785973
Lead Sponsor: Minia UniversityOTHER
Overall Status: Recruiting
Study Type: Interventional
Phase: Not Applicable
Enrollment: 30Estimated
Last Update Posted: Aug 25, 2026Actual
Start Date: Aug 1, 2026Actual
Primary Completion Date: Aug 1, 2027Estimated
Completion Date: Aug 10, 2027Estimated

Description

What the study is about and why it is being run, in the researchers' own words.

Official Title: Effect of NeoSEALER FLO and AH Plus Resin Sealer on Postoperative Pain and Healing of Periapical Lesions: A Randomized Clinical Study
Brief Summary: Tissue repair is an essential process that reestablishes tissue integrity and regular function. Nevertheless, different therapeutic factors and clinical conditions may interfere in this process of periapical healing.The success of root canal treatment is affected by the correct choice of clinical protocol.

These factors are dependent on the sanitization process (instrumentation, irrigating solution, irrigating strategies, and intracanal dressing) the apical limit of the root canal preparation and obturation, and the quality of the sealer. The challenges affecting the healing process of endodontically treated teeth include control of the inflammation of pulp or infectious processes and simultaneous neutralization of unpredictable provocations to the periapical tissue.
Detailed Description

Conditions

The medical conditions and diseases this study investigates.

Post Operative Pain

Interventions

The treatments and procedures being evaluated in this study.

AH plus sealer

Participation

Who can join this study and the criteria used to decide.

Ages Eligible for Study: Adult (18-64)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Yes
Eligibility Criteria: Inclusion Criteria:

Patients with mature permanent teeth.

Patients with apical periodontitis.

Maxillary anterior teeth only will be involved.

Patients should be free from any systemic disease that may affect normal healing and predictable outcome.

Patients who will agree to the consent and will commit to follow-up period.

The selected teeth should have periapical lesion score ≤3

Exclusion Criteria:

Patients with immature canals.

Patients with swelling.

Pregnant females.

Patients who could/would not participate in a 1-year follow-up.

Geriatric patients.

Patients with old age.

Teeth with periodontal involvement.

Teeth with vertical root fractures.

Non-restorable teeth.

cases with previously initiated endodontic treatment.

Design

How the study is designed and how its participant groups are organized.

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Contacts

The people to reach with questions about this study or how to join it.

Allaa Mohamed Kamel Mohamed, MSCContact

allaa91mk@gmail.com+201006767773

Locations

Where the study is run and whether each site is currently recruiting.

Minia University, Faculty of DentistryRecruiting

Minya, Egypt

Collaborators

The organizations and people involved in this study.

Lead Sponsor: Minia UniversityOTHER

Similar Studies

Other registered studies that closely resemble this one.

The goal of root canal obturation is to obtain complete sealing to hinder the communication between the root canal and the periapical tissue. This favors the process of apical and periapical repair after endodontic therapy.An ideal root canal sealer must have adequate physical, chemical, and biological properties.

Several factors can affect the success of RCT, including the type and composition of sealer utilized. The presence and release of substances from the sealers can cause different reactions when in contact with tissue.

AH Plus, an epoxy resin-based sealer, is considered the gold standard among root canal sealers due to its excellent physical, chemical, and biological properties. However, the biocompatibility of this sealer remains a subject of debate, as some studies raise concerns about potential inflammatory responses or cytotoxic effects associated with resin-based sealers.

Recent advancements have introduced bioceramic-based sealer composed of zirconium oxide, calcium silicates, calcium phosphates, and calcium hydroxide. This sealer is available in pre-mixed syringes for easy application and exhibit hydrophilic properties, allowing for setting reactions in a moist environment within the root canal, thus preventing shrinkage. Moreover, bioceramic-based sealers exhibit favorable biocompatibility due to their similarity to dentin and ability to stimulate mineralization.

NeoSealer Flo (NeoFlo, NuSmile, Houston, TX, USA) is a ready-to-use bioceramic root canal sealer. According to the manufacturer, it has hydroxyapatite formation ability, biocompatibility, dimensional stability, and antimicrobial activity. NeoFlo has adequate physicochemical properties and releases biologically active ions, such as calcium and phosphate. The addition of cetrimide to NeoSealer Flo promoted a greater inflammatory reaction, but the reduction of inflammatory cells and rearrangement of connective tissue suggests that NeoSealer Flo and the associations with cetrimide are biocompatible and have bioactive potential.

Endodontic treatment comprises the overall management of pre-, intra- and post-operative symptoms, including post-operative endodontic pain, considered as a complication susceptible to chronicization. Post-operative pain is very common and highly unpreventable and has a multifactorial etiology and a potential pathogenic link to the acute inflammation of the periapical area, secondary to localized chemical, mechanical, host and/or microbial damage occurring during endodontic treatment.