The Effect of Saline Irrigation at Different Temperatures on Pain, Edema, and Trismus After Impacted Third Molar Surgery: A Prospective, Randomized, Split-Mouth, Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Trakya University
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Change in Facial Swelling
Study Overview
Brief Summary
Third molar surgery is one of the most common procedures in oral surgery and the most common postoperative complications are swelling, pain, and trismus. This study aims to evaluate the postoperative morbidity (pain, swelling, and trismus) in third molar surgery performed using different degrees of cooled and room temperature irrigation solutions.
Detailed Description
This single-blind, single- centre, split-mouth, superiority randomized prospective clinical trial was approved by The Ethics Committee of Trakya University, Medical Sciences (Decision no: 13/10). The sample size calculation based on data obtained from a previous study indicated that 48 patients would be sufficient per group (80% power and 5% significance level).
Adult patients (18 - 59 years of age) referred to the Trakya University, Faculty of Dentistry, Department of Oral and Maxillofacial Surgery between September 2018 and December 2020 were examined clinically and radiographically.
Inclusion criteria:
- Patients who fit the requirements of the study such as attending follow up sessions and signing the informed consent.
- Patients who had bilateral asymptomatic vertical third molar teeth with impaction of class I, level C (21).
- Patients who had no significant medical diseases or use of drugs, were not pregnant, had no allergy, and did not smoke.
A patient was excluded if any of the following conditions were observed:
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Volunteers over the age of 18
- •Patients who had no significant medical diseases or use of drugs, were not pregnant, had no allergy, and did not smoke.
- •Patients who had bilateral asymptomatic vertical third molar teeth with impaction of class I, level C according to Pell and Gregory Classification, and no history of recent antibiotic or anti-inflammatory treatment.
Exclusion Criteria
- •Patients who had symptomatic impacted third molars.
- •Patients who had a medical history described above.
- •Patients under the age of 18.
Arms & Interventions
Experimental Group A
In experimental group A, 4°C saline irrigation was used for removal of the bone surrounding the right or left third molars.
Intervention: 4 °C colled saline irrigation (Procedure)
Experimental Group B
In experimental group B, 10°C saline irrigation was used for removal of the bone surrounding the right or left third molars.
Intervention: 10 °C cooled saline irrigation (Procedure)
Control Group A
In control group A, room temperature saline was used for the other side extractions of patients whose impacted tooth was extracted under 4 °C saline irrigation on one side.
Intervention: Room temperature saline irrigation (Procedure)
Control Group B
In control group B, room temperature saline was used for the other side extractions of patients whose impacted tooth was extracted under 10 °C saline irrigation on one side.
Intervention: Room temperature saline irrigation (Procedure)
Outcomes
Primary Outcomes
Change in Facial Swelling
Time Frame: 7 days
three measurements between 5 reference points were performed with a flexible ruler: tragus to soft tissue pogonion, lateral corner of the eye to the angle of the mandible, and tragus to the outer corner of the mouth. The sum of the 3 measurements was calculated preoperatively and repeated.The difference between each postoperative measurement and the preoperative measurement was determined as the value for facial swelling.
Change in pain
Time Frame: 7 days
Postoperative pain was evaluated by the Visual Analogue Scale (VAS) from "0" (as no pain) to "10" (as the most severe pain experienced).
Change in trismus
Time Frame: 7 days
Trismus was assessed by measuring the distance between the mesial incisal corners of the right upper and lower central teeth when the patient had maximum mouth opening. The difference between each postoperative measurement and the preoperative measurement indicated the trismus for that day.
Secondary Outcomes
- Change in the number of analgesic(7 days)
Investigators
Fatma Gülfeşan Çanakçi
Assistant Professor
Trakya University