Evaluation of the Impact of Different Final Irrigation Activation Modes on Healing of Periapical Lesions Related to Permanent Mandibular First Molars Using CBCT.

NCT07589556 | Active Not Recruiting DMC

• 1 other identifier: FUE.REC (45)/11-2024
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn how different ways of activating the cleaning liquid (irrigation) during endodontic treatment affect healing of infections at the root tip (periapical lesions) in adults aged 20 to 40 with a lower first molar tooth. The main question it aims to answer is: Does the way the cleaning liquid is moved inside the tooth during endodontic treatment change how well the infection at the root tip heals after 12 months? Researchers will compare four irrigation methods to see which one helps the infection heal best: A regular needle and syringe (the standard endodontic method) Ultra X, which uses sound waves to push the liquid through the tooth Endo Vac, which uses gentle suction to pull the liquid through the tooth I Vac, which combines suction and sound waves Participants will: Have their endodontic treatment done in one visit by the same dentist Be randomly placed into one of the four groups Return for check-ups at 3, 6, and 9 months after endodontic treatment Come back at 12 months for a final check-up and a 3D dental scan (CBCT) to measure how much the infection has healed

Conditions

Necrotic Pulp With Symptomatic Apical Periodontitis

Keywords

apical periodontitis; iVac; healing; CBCT; Final Irrigation protocol; EndoVac; ultrasonic; Root canal treatment

Outcome Measures

Primary Outcomes (1)

• healing of periapical lesion

  percent reduction lesion size after root canal treatment using CBCT-PAI scores

  12 month

Study Arms (4)

side vented needle

PLACEBO COMPARATOR

single visit root canal treatment with final irrigation protocol using side vented needle

Procedure: root canal treatment

passive ultrasonic irrigation activation (Ultra X )

ACTIVE COMPARATOR

single visit root canal treatment with final irrigation protocol using ultrasonic ( Ultra X )

Procedure: root canal treatment

apical negative pressure irrigation activation ( Endo Vac)

ACTIVE COMPARATOR

single visit root canal treatment with final irrigation protocol using apical negative pressure irrigation activation( Endo Vac )

Procedure: root canal treatment

Apical Negative Pressure Irrigation and Activation System (iVac)

ACTIVE COMPARATOR

single visit root canal treatment with final irrigation protocol using Apical Negative Pressure Irrigation and Activation System (iVac)

Procedure: root canal treatment

Interventions

root canal treatment PROCEDURE

single visit root canal treatment with final irrigation protocol according to arm

Apical Negative Pressure Irrigation and Activation System (iVac); apical negative pressure irrigation activation ( Endo Vac); passive ultrasonic irrigation activation (Ultra X ); side vented needle

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- Medically free patients with no systemic disease: (American Society of Anesthesiologists / (ASA Class I or II).
• The age range is between 20 to 40 years.
• Patients have restorable Mandibular permanent molars that were diagnosed with necrotic pulp with symptomatic apical periodontitis (with small to moderate periapical lesion/≤ 5mm) .
• Positive patient's acceptance for participating in the study.
• Patients able to sign informed consent.
• Both male and female patients are eligible.
• Good oral hygiene.
• Mandibular first molars with two roots (mesial and distal), each presenting a Weine Type III canal configuration.

You may not qualify if:

• \- Medically compromised patients.
• Pregnant or lactating females.
• Psychologically disturbed patients.
• Patients with a history of allergy to any medication used in the study were excluded.
• Mandibular first molar with:
• Wide or open apex.
• Vital pulp tissues.
• Periodontally affected with grade 2 or 3 mobility.
• Not restorable teeth.
• Abnormal anatomy and calcified canals.
• Previous root canal treatment.

Sponsors & Collaborators

• Future University in Egypt: lead

Study Sites (1)

Future university in Eygpt

Cairo, New Cairo, 118535, Egypt

Location

MeSH Terms

Conditions

Periapical Periodontitis

Condition Hierarchy (Ancestors)

Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: the first blinding will be to the participants, where they will not know the type of irrigation activation device used the second blinding will be to the investigator, where another individual will be assigned to follow up with the participants and record the outcome measures the third blinding will be to the outcome assessors, where they will be blinded to the groups
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical instructor

Study Record Dates

• First Submitted: May 11, 2026
• First Posted: May 15, 2026
• Study Start: January 15, 2025
• Primary Completion: May 3, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: May 15, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)