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Postoperative Pain After Activation of Irrigant

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06528574
Enrollment
84
Registered
2024-07-30
Start date
2023-08-01
Completion date
2025-04-30
Last updated
2024-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Brief summary

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.

Interventions

Root canals will be irrigated by only side perforated needle

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

DEVICEApical negative pressure

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

DEVICECombined Ultrasonic and negative pressure

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

Sponsors

Cleveland Dental Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

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 \-

Design outcomes

Primary

MeasureTime frameDescription
Numerical Pain Scale (NRS)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

MeasureTime frameDescription
Analgesics intake6 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

Countries

United States

Contacts

Primary ContactAhmed A Hashem, PhD
a.hashem@cdiohio.org4405021591
Backup ContactWaleed Elmallah, PhD
w.elmallah@cdiohio.org2163336695

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026