NCT07785973

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
11mo left

Started Aug 2026

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress8%
Aug 2026Aug 2027

Study Start

First participant enrolled

August 1, 2026

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

August 21, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 25, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2027

Last Updated

August 25, 2026

Status Verified

August 1, 2026

Enrollment Period

1 year

First QC Date

August 21, 2026

Last Update Submit

August 21, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Treatment of Postoperative Pain

    Patients will be evaluated for postoperative pain via (NRS) to record the intensity of pain.as follows: 0 reading represents "no pain" ; 1- 3 reading represents "mild pain" ; 4- 6 reading represents "moderate pain" and 7- 10 reading represents "severe pain".

    from 0 hours to 2 weeks after the procedure

Secondary Outcomes (1)

  • Periapical Healing

    After 6 months to 12 months

Study Arms (2)

AH plus sealer

ACTIVE COMPARATOR

About 15 cases will undergo the AH plus sealer during obturation After complete preparation of the root canal system

Procedure: AH plus sealer

NeoSEALER FLO

ACTIVE COMPARATOR

About 15 cases will undergo the Neo Sealer FLO during obturation After complete preparation of the root canal system

Procedure: AH plus sealer

Interventions

to evaluate and compare postoperative pain and periapical healing after root canal treatment using two different base endodontic sealers: * NeoSEALER Flo * AH plus Resin sealer

Also known as: NeoSEALER FLO
AH plus sealerNeoSEALER FLO

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Minia University, Faculty of Dentistry

Minya, Egypt

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

epoxy resin-based root canal sealer

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Maged Mohamed Negm, M.D

    Professor of Endodontics, Faculty of Dentistry,Cairo University

    STUDY CHAIR

Central Study Contacts

Allaa Mohamed Kamel Mohamed, MSC

CONTACT

Maged Mohamed Negm, professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer at Endodontics Department,Faculty of Dentistry,Lotus University

Study Record Dates

First Submitted

August 21, 2026

First Posted

August 25, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 10, 2027

Last Updated

August 25, 2026

Record last verified: 2026-08

Locations