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Completed

NCT Number: NCT05904873

Cold Press Test and Post Operative Pain Relationship

The goal of this clinical trial is to investigate whether it is possible to get a preliminary idea about the postoperative pain in the patient with the results of a practical cold press test applied to American Society of Anesthesiologists(ASA) 1 and 2, healthy, male patients aged 16-35 before extraction of the lower third molar. The main question it aims to answer are:

• Can post-operative pain be predicted with an cold test that can be applied more practically than conventional quantitative sensory tests applied preoperatively? Participants will need to keep their hands on ice for 240 seconds prior to third molar surgery. When they take their hands off the ice, they will be asked to describe their pain on the visual analog scale. After the operation, the participants are required to mark whether they use painkillers every 8 hours in their pain follow-up forms and the pain they feel according to the visual analog scale.

Depending on the endurance time of the participants to keep their hands on the ice; Two different groups were determined as less than 240 sec and equal to 240 sec. The pain scores and the amount of painkiller use between these two groups were compared with each other.

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Key information

Conditions

Post-operative Pain, Acute Neurologic Manifestations Pain Pain Threshold Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

16 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Marmara University

Istanbul, 34854, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • The impacted third molar should be class 1 or 2 and position B according to Pell & Gregory classification.
  • The impacted third molar should be asymptomatic.
  • The impacted third molar should be located in the mandible and be in the mesioangular or vertical position.
  • To be male gender
  • To be in American Society of Anesthesiologists 1 or 2 classification
  • To be between the ages of 16-35

Exclusion criteria

  • Intolerance to non-steroidal anti-inflammatory drugs
  • Smoking more than 10 cigarettes a day
  • Operation time exceeding 20 minutes
  • Individuals who have performed third molar tooth extraction

Treatment and study plan

Mandibular Third Molar Surgery

Procedure

All surgical procedures were carried out by a single dental(maxillofacial) surgeon different from the clinician performing the cold testing. A total of 4 cc of local anesthetic solution containing 40 mg/ml articaine and 0.005 mg/ml epinephrine was applied to the inferior alveolar and buccal nerve blocks before the surgical procedure. In all cases, the mucoperiosteal flap was raised and bone was removed from the buccal and distal parts of the impacted tooth with burs, while protecting the papilla between the first and second molars during flap design. Before extraction, if necessary, the third molar was divided and tooth extraction was performed with elevators. The flap was brought to its original position and closed with silk suture material.

Primary outcomes

  1. Measurement of Post-Operative Pain

    Time frame: 4 days

    To measure postoperative pain, all participants were given a form to fill out after surgery. In the form, there were areas where the participant should indicate pain between 0 and 10 according to the VAS scale . Forms were collected from each participant at the end of 4 days after the operation.

Secondary outcomes

  1. Measurement of Painkiller Use In The Post Operative Period

    Time frame: 4 days

    To measure the amount of painkillers used post-surgery, all participants were given a form to fill out. In the form, there were areas where the participant should mark the use of ibuprofen in the first 0-2 hours and then every 8 hours. If paracetamol, which is the rescue medicine, is used, it was requested to mark the time and date in the table in the last part of the form. Forms were collected from each participant at the end of 4 days after the operation.

Sponsors and collaborators

Lead sponsor

Sinem Büşra Kıraç Can

Other

Registry information

Official study title

Can a Preoperative Cold Press Test be a Predictor of Pain After Third Molar Surgery?

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 15, 2023
Registry last updated
Jun 15, 2023

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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