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NCT Number: NCT06528574

Postoperative Pain After Activation of Irrigant

The purpose of this research is to analyze the levels of pain after cleaning and shaping in individuals who are receiving root canal therapy using the IVAC irrigation approach, and those who are treated with ultrasonic irrigation techniques, negative pressure irrigation technique and traditional irrigation techniques.

PICOTS Question:

Does the new Dent's iVac irrigation protocol has an effect on reduction of postoperative pain

By enlisting at least 84 suitable individuals who are undergoing the identical endodontic procedure.

pain will be measures by assessing pain levels through a standardized numerical rate scale (NRS) at certain time intervals after root canal treatment, 6 hours, 12 hours, 24 hours, 48 hours, and 72 hours.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Males and females Age :20-50 Mandibular mature first molars with symptomatic acute pulpitis Medically free patients

Exclusion criteria

Pulp necrosis or apical periodontitis Periodontal disease Vertical root fracture Radiographic apical radiolucency

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Treatment and study plan

Conventional root canal treatment

Device

Root canals will be irrigated by only side perforated needle

Ultrasonic

Device

Root canals will finally receive activation of the irrigant by the ultrasonic part of the IVAC system

Apical negative pressure

Device

Root canals will finally receive activation of the irrigant by the negative pressure part of the IVAC system

Combined Ultrasonic and negative pressure

Device

Root canals will finally receive activation of the irrigant by the IVAC system which is a combination of ultrasonic and apical negative pressure procedures.

Primary outcomes

  1. Numerical Pain Scale (NRS)

    Time frame: Preoperative, 6 hours, 12 hours, 24 hours, 48 hours and 72 hour post-procedure.

    Pain will be assessed during the numerical rate scale (NRS) which has a scale from 0 to 10, where 0 is no pain while 10 is most unbearable one.

Secondary outcomes

  1. Analgesics intake

    Time frame: 6 hours, 12 hours, 24 hours,48 hours and 72 hour post-procedure.

    The patient will be advised to take analgesics in case of unbearable pain and record this. Number of tablets and the time will be recorded

    ● The satisfaction of patients regarding the pain management intervention at the follow-up

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed A Hashem, PhD

CONTACT

[email protected]

4405021591

Waleed Elmallah, PhD

CONTACT

[email protected]

2163336695

Sponsors and collaborators

Lead sponsor

Cleveland Dental Institute

Other

Registry information

Official study title

Incidence of Postoperative Pain After Activation of Irrigant With Apical Negative Pressure and Ultrasonics in Mandibular Molar Teeth With Irreversible Pulpitis: A Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Jul 30, 2024
Registry last updated
Jul 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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