The Impact of Using Different Final Irrigation Modes on Postoperative Pain Following Root Canal Treatment of Non-vital Mandibular First Molar With Periapical Lesion.

NCT07623629 | Active Not Recruiting DMC

• 1 other identifier: FUE.REC (48)/11-2024
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn which rinsing of root canals method works best to lower pain after a root canal in adults. The study focuses on participants aged 20 to 40 with an infection in a lower back tooth (mandibular first molar) and a small area of bone loss at the root tip. The main questions it aims to answer are: Does the type of tool used to rinse the tooth root canal change how much pain a participant feels after treatment? Does the cleaning method lower the number of painkillers a participant needs to take? Researchers will compare four different rinsing tools-ranging from a standard needle to advanced vacuum and vibration devices-to see if using suction and sound waves can lower pain levels. Participants will: Receive a complete root canal treatment in a single visit Be randomly assigned to one of four cleaning groups (standard rinse, vibration, vacuum, or a combination of both) Rate their pain on a scale of 0 to 10 at five specific times: before the visit, and at 6, 12, 24, and 48 hours after treatment Record how many painkiller tablets (Ibuprofen) they take during the two days following the procedure

Conditions

Necrotic Pulp With Symptomatic Apical Periodontitis

Keywords

Ivac; apical periodontitis; postoperative pain; single visit root canal treatment; final irrigation protocol

Outcome Measures

Primary Outcomes (1)

• postoperative pain

  modifies visual analog scale (vas) with values from 0 to 10, where 0 value means no pain and 10 means worst pain and 6 faces describing the comfort, where the first face means "does not hurt" up to the last face "hurts worst"

  Before treatment, 6 hours after treatment, 12 hours after treatment, 1 day after treatment, 2 days after treatment.

Secondary Outcomes (1)

• Analgesic intake

  6 hours after treatment, 12 hours after treatment, 1 day after treatment, 2 days after treatment.

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

ACTIVE COMPARATOR

single visit root canal treatment with final irrigation protocol using ultrasonic (ultraX) irrigation activation protocol

Procedure: root canal treatment

apical negative pressure irrigation activation

ACTIVE COMPARATOR

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

Procedure: root canal treatment

iVac™ Apical Negative Pressure Irrigation and Activation System

ACTIVE COMPARATOR

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

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 activation; iVac™ Apical Negative Pressure Irrigation and Activation System; passive ultrasonic irrigation activation; side vented needle

Eligibility Criteria

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

You may qualify if:

• Lower first molar Classification of root canal configuration according to weine classification: -
• Distal root: any type of root canal configuration given that the portal of exit is through only one apical foramen
• Mesial root: any type of root canal configuration given that the portal of exit is through only one apical foramen(18).
• Patient with mild pre-operative pain with pain score from 0-3
• 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 lower permanent molars that were diagnosed with symptomatic apical periodontitis with small to moderate periapical lesion.
• Positive patient's acceptance for participating in the study.
• Patients able to sign informed consent.

You may not qualify if:

• Patients with systemic conditions that may affect pain perception (e.g., fibromyalgia, chronic pain disorders)
• Patients currently taking or taken analgesics or anti-inflammatory medications before the trial in the last 12 hours.
• Pregnant or lactating females.
• Psychologically disturbed patients.
• Patients with a history of allergy to any medication used in the study are excluded.
• Teeth that have:
• 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 Egypt

Cairo, New Cairo, 11835, Egypt

Location

MeSH Terms

Conditions

Periapical Periodontitis; Pain, Postoperative

Condition Hierarchy (Ancestors)

Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• hesham mohamed salah, lecturer

  Future University in Egypt

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, 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: June 3, 2026
• Study Start: January 3, 2026
• Primary Completion: May 5, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: June 3, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)