Clinical trial NCT06020053: Effect of Using Irrigations at Different Temperatures on Postoperative Period During the Extraction of Impacted Mandibular Molars
Official title: Effect of Using Irrigations at Different Temperatures on Postoperative Period During the Extraction of Impacted Mandibular Molars
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Impacted Third Molar Tooth
Keywords: irrigation,
third molar surgery,
temperature,
Lead sponsor: Firat University
Sponsor class: OTHER
First posted: 2023-08-31
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: An Evaluation of the Effect of Using Irrigations at Different Temperatures on Pain, Edema, and Trismus During the Extraction of Bilateral Impacted Mandibular Third Molars: A Randomized Split-Mouth Clinical Trial

Detailed description: Abstract Introduction: The surgical extraction of impacted wisdom teeth is a standard practice in dentistry. Unfortunately, inflammatory reactions such as discomfort, edema, and trismus frequently jeopardize patients' well-being after the extraction of third molars. Saline solutions at room temperature (25°C) are routinely used in impacted tooth extraction. Refrigerated serums were used to work with cold serum, and since the refrigerator temperature was 4°C, this study was designed to have a cold serum temperature of 4°C. This study aims to assess the influence of saline irrigation at various temperatures (4°C, 25°C) on postoperative edema, pain, and trismus after the extraction of impacted third molars.

Materials and Methods: Eighteen patients with bilateral symmetrical mandibular impacted third molars were enrolled in this split-mouth, randomized, prospective, double-blind clinical trial. For each patient, one side was irrigated with a solution at 4°C (test), and the other side was irrigated with a solution at room temperature (25°C) (control). Pain, trismus, and facial edema were noted on the 2nd, 4th, and 7th days. A Mann-Whitney U-test was used to compare pairs, and a Wilcoxon signed-rank test was used to compare groups.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18 to 30 who were classified as ASA (American Society of Anesthesiologists)1 and who required the removal of impacted third molars on either the right or left side of the mandible;
* Presence of impacted mandibular third molars on panoramic radiographs, bilaterally symmetrical, with bone retention and bone removal for extraction, position B class 2 of impacted teeth according to the Pell and Gregory Classification System, and mesioangular position according to the Winter Classification;
* Absence of systemic disease and habitual smoking behavior and absence of an allergy to the drugs to be used postoperatively.

Exclusion Criteria:

* Patients with a history of taking antibiotics and analgesics for at least one month;
* Having an infection in the operation area and acute pericoronitis or severe periodontal disease before the operation;
* The existence of cysts and tumors within proximity of the impacted third molar.

Primary outcomes:
measure: Pain was noted on the 2nd, 4th, and 7th days.
timeFrame: on the 2nd, 4th, and 7th days.
Secondary outcomes:
measure: trismus was noted on the 2nd, 4th, and 7th days.
timeFrame: on the 2nd, 4th, and 7th days.
measure: facial edema was noted on the 2nd, 4th, and 7th days
timeFrame: on the 2nd, 4th, and 7th days.
Other outcomes:
Locations:
city: Merkez
country: Turkey
facility: Fırat Üniversitesi
state: Elaziğ
Study officials:
affiliation: Firat University
name: muhammet ozupek
role: STUDY_DIRECTOR
References: