University of Health Sciences, Keciören, Ankara
Ankara, 06610, Turkey (Türkiye)
NCT Number: NCT07835958
The present study aims to compare the effects of saline, chlorhexidine, and hydrogen peroxide irrigation solutions at different temperatures on postoperative complications, including pain, swelling, and mouth opening, as well as oral health-related quality of life, in patients undergoing surgical extraction of impacted mandibular third molars. The irrigation solutions will be applied immediately following surgical tooth extraction at temperatures of either 4°C or 25°C.
An a prior power analysis based on repeated-measures analysis of variance (Repeated Measures ANOVA, within-between interaction) was performed. An effect size of f = 0.25, a Type I error rate (α = 0.05), and a statistical power of 1 - β = 0.95 were assumed.
Based on the power analysis, a minimum of 11 participants per group was determined to be sufficient. Considering potential loss to follow-up and missing data, the sample size was increased by approximately 15%, and it was decided to enroll 13 participants in each group. Accordingly, the planned study will be conducted with a total of 78 participants allocated to six groups, and all participants will be evaluated at four different time points.
Trial opening soon.
Get Notified18 year–35 year
All sexes
Interventional
Not applicable
Ankara, 06610, Turkey (Türkiye)
The removal of mandibular third molars is among the most common procedures carried out in oral surgery. After extraction, patients often experience postoperative complications such as pain, swelling, and limited mouth opening. If these complications become more severe, they can negatively impact the patient's oral health-related quality of life.
In mandibular third molar surgery, following elevation of the soft tissue flap to gain access to the tooth, bone removal is performed using high-speed rotary instruments with continuous irrigation using physiological solutions . Following bone removal and exposure of the tooth, the extraction is performed. Subsequently, irrigation of the extraction socket with physiological saline or antiseptic solutions has been recommended. After socket irrigation and evaluation of the bony structures, the surgical site is sutured and postoperative instructions are provided to the patients.Although the aforementioned studies have demonstrated that socket irrigation may produce favorable postoperative outcomes, to the best of our knowledge, no study has evaluated the effectiveness of irrigation solutions used at different temperatures for socket irrigation.Therefore, the present study aims to compare the effects of saline, chlorhexidine, and hydrogen peroxide irrigation solutions at different temperatures on postoperative complications, including pain, swelling, and mouth opening, as well as oral health-related quality of life, in patients undergoing surgical extraction of impacted mandibular third molars. The irrigation solutions will be applied immediately following surgical tooth extraction at temperatures of either 4°C or 25°C.
The present study aims:
Accordingly, the planned study will be conducted with a total of 78 participants allocated to six groups, and all participants will be evaluated at four different time points.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients whose extraction sockets will be irrigated with 4°C sterile saline solution following mandibular third molar surgery.
Patients whose extraction sockets will be irrigated with 25°C sterile saline solution following mandibular third molar surgery.
Patients whose extraction sockets will be irrigated with 4°C 0.2% chlorhexidine solution following mandibular third molar surgery.
Patients whose extraction sockets will be irrigated with 25°C 0.2% chlorhexidine solution following mandibular third molar surgery.
Patients whose extraction sockets will be irrigated with 4°C 1.5% hydrogen peroxide solution following mandibular third molar surgery.
Patients whose extraction sockets will be irrigated with 25°C 1.5% hydrogen peroxide solution following mandibular third molar surgery.
Time frame: Preoperatively and on postoperative days 2, 4, and 7
Edema will be measured along five predetermined anatomical reference lines using a flexible millimeter ruler. Measurements will be recorded in millimeters.
Time frame: Preoperative and postoperative days 2, 4, and 7 using a 10-cm VAS.
Postoperative pain will be assessed by Visual Analog Scale (VAS). The amount of analgesic required by each patient during the postoperative period will be recorded daily on the patient follow-up form.
Time frame: Preoperative day and postoperative days 2, 4, and 7
Maximum mouth opening will be measured in millimeters using a digital caliper.
Time frame: Preoperatively and on postoperative days 2, 4, and 7.
The Oral Health Impact Profile-14 (OHIP-14), a validated and reliable instrument, will be used to evaluate changes in patients' daily comfort and oral health-related quality of life.
Contact information is provided by the study sponsor or research team.
Saglik Bilimleri Universitesi
Other
A Comparison of the Effects of Irrigation Solutions at Different Temperatures Used in Oral Surgery on Postoperative Complications and Oral Health-Related Quality of Life
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