Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05170516 |
| Other study ID # |
TrakyaU 2018 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 15, 2018 |
| Est. completion date |
December 15, 2020 |
Study information
| Verified date |
January 2022 |
| Source |
Trakya University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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:
1. Patients who fit the requirements of the study such as attending follow up sessions and
signing the informed consent.
2. Patients who had bilateral asymptomatic vertical third molar teeth with impaction of
class I, level C (21).
3. 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:
1. Patients who have a complicating systemic disease (ASA: 3- 6).
2. Patients who have second molars with severe periodontal defect or deep periodontal
pocket (probing depth >4mm)
3. Patients who have a poor oral hygiene
4. Patients who have history of having taken analgesics 12 h or antibiotics 1 month before.
Fourty eight patients were randomly allocated to two groups (Group A and B)(n =24). For
randomization, a dentist blinded to the study took a sealed envelope from the bag, which
contained group codes. Bilateral impacted third molars (a total of 96 teeth) were extracted
from each patient in 2 different operation time. The second operation that was performed at
least 21 days after the first ones to return the variables to preoperative values. Each
patient had an experimental (one side with 4°C or 10°C saline irrigation) and control (the
other side with 25°C saline irrigation ) group impacted third molars.
All procedures were completed by a single operator who had ten years of experience. Inferior
alveolar nerve, lingual and buccal nerve blocks were performed using a local anesthetic
containing 0.006 mg/ml adrenaline hydrochloride and 40 mg/ml articaine hydrochloride (2 ml
Ultracaine® D-S Ampul, Sanofi Aventis). The flap was released with a triangular incision.
Osteotomies were made with a 1.6 mm round bur attached to a surgical high-speed handpiece
(W&H Implantmed, W&H, St Albans, UK) at 20000 rpm under saline irrigation at the temperature
determined according to the groups.
During operations, the temperatures of the salines were verified with a non-contact
thermometer (Omron Gentle Temp 720 MC, Omron Healthcare Co., Ltd., Kyoto, Japan) every 30
seconds. When temperature changes were detected, the correct temperature was achieved with
the addition of cooled irrigation. After tooth extraction flap was sutured with a 3.0 silk
suture which was removed 7 days after the surgery. The operation time was determined as the
time between the first incision and the last suture and recorded.
Biting a gauze pack for 30 minutes, an ice pack compression (5 minutes on and 5 minutes off)
for 6 hours, and having a soft and cold diet for 24 hours were recommended. Amoxicillin 500
mg 3 times/day for 5 days and 0.12% chlorhexidine digluconate mouthwash 3 times/day for 7
days were prescribed. The patients were also advised to take paracetamol 500 mg as required.
Assessment of postoperative pain before participation, all patients had read and signed an
informed consent form. All patients were given a pain form to report the level of
postoperative pain. Before the beginning of treatment, the clinician filled in an example of
a pain report with each patient to confirm that they understood the instructions.
Postoperative pain was evaluated by the Visual Analogue Scale (VAS) from "0" (as no pain) to
"10" (as the most severe pain experienced) for postoperative 7 days. And also patients were
asked to record the number of analgesics they used in 1 day for 7 days. Patients were not
aware of the side and the type of cooled irrigation in order not to affect VAS scores and the
total number of analgesics.
Postoperative measurements were made by a single surgeon blinded to operative procedures.
Patients were recalled on the 24th and 72nd hours and 7th days postoperatively, and trismus
and facial swelling measurements were made.
The level of facial swelling was determined by a method described by Üstün et. al. (22). To
assess facial swelling, 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 on postoperative days 1, 3, and 7. The difference
between each postoperative measurement and the preoperative measurement was determined as the
value for facial swelling.
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 on
postoperative 1, 3, 7 days. The difference between each postoperative measurement and the
preoperative measurement indicated the trismus for that day.
