Evaluation of the Effect of Circadian Rhythm of Adrenal G... | NCT06610383

Status Module

Description Module

Detailed Description

This clinical study was conducted on 20 patients who applied to the Afyonkarahisar Health Sciences University (AFSU) Faculty of Dentistry, Department of Oral and Maxillofacial Surgery between November 2021 and July 2022 for surgical extraction of mandibular impacted third molars in the same impaction class (Mesioangular-Pell and Gregory class II-B) bilaterally. This study was created by including 20 patients who applied to the AFSÜ Faculty of Dentistry, Oral, Dental and Maxillofacial Surgery Clinic due to the presence of impacted teeth and/or complaints caused by their impacted teeth, and who were decided to have symmetrical, bilateral, bone-retained (Mesioangular) third molars in the mandible extracted as a result of clinical examination and radiographic evaluations.

Participation in this study was completely up to the participant. If the participant did not want to participate in the study or withdrew, the doctor still applied the most appropriate treatment plan for the participant.

During the surgery for your wisdom teeth, we took a saliva sample from the participant before anesthesia, on the 2nd and 7th postoperative days, and measured the amount of steroids secreted from your body through your saliva. The participant's pain, swelling, and trismus values were assessed using reference points on your face and pain scales on the day he/she came to the surgery, the 2nd day, and the 7th day. The study has no risks or discomfort. Based on the results of this study, surgeons will be able to evaluate the effects of adrenal steroids at different times of the day and determine when their procedures will be more comfortable. Participants did not incur any financial burden by participating in the study, and no payment was made to the participants. The researchers will use the participants' personal information to conduct the study and statistical analyses, but the participants' identities will be kept confidential. Ethics committees or official authorities may review the participants' information only when necessary. At the end of the study, the study results may be published in the medical literature, but your identity will not be disclosed.

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1 (08:30 group (n=20))		Patients in this group will spit into 1.5 ml tubes at 08:30 in the morning before starting the impacted tooth surgery and 48 hours after the surgery, and these tubes will be stored in the refrigerator at -22 degrees. The samples in these tubes will then be examined with ELISA kits and the numerical data of adrenal glucocorticoids in the saliva will be obtained. The patients will fill out the Visual Analog Scale and OHIP-14 forms a total of five times: 6 hours, 24 hours, 48 hours, 72 hours and 7 days after the surgery.	Procedure: Surgical extraction of wisdom teeth in the morning
Group 2 (15:30 group (n=20))		Patients in this group will spit into 1.5 ml tubes at 15:30 in the morning before starting the impacted tooth surgery and 48 hours after the surgery, and these tubes will be stored in the refrigerator at -22 degrees. The samples in these tubes will then be examined with ELISA kits and the numerical data of adrenal glucocorticoids in the saliva will be obtained. The patients will fill out the Visual Analog Scale and OHIP-14 forms a total of five times: 6 hours, 24 hours, 48 hours, 72 hours and 7 days after the surgery.	Procedure: Surgical extraction of wisdom teeth in the afternoon

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Surgical extraction of wisdom teeth in the morning	Procedure	The patients in this group underwent impacted tooth surgery at 08:30 in the morning.	Group 1 (08:30 group (n=20))

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain Assessment	A 100 mm VAS scale was used to assess postoperative pain. Patients were asked to mark the appropriate part of their pain on the scale during preoperative and postoperative 2nd-7th day controls. In order to standardize analgesic use, patients were informed verbally and in writing that the first analgesic should be taken 1 hour after the operation and then every 8 hours for 3 days, regardless of pain.	preoperative and postoperative days 2-7
Evaluation of Edema	In the postoperative edema assessment, the tragus, soft tissue pogonion, lateral canthus of the eye, gonion point on the mandible angulus and commissura labiorum were used as anatomical reference points. In the measurements; tragus-lateral canthus, tragus-commissura lobiorum, tragus-soft tissue pogonion, tragus-gonion and gonion-lateral canthus lengths were measured with a flexible ruler and calculated linearly. Preoperative measurement values were accepted as basic values and measurements on postoperative 2nd and 7th days were compared both between the groups and on the preoperative measurement values. Data were created and evaluated by taking the arithmetic average of the measured distances.	preoperative and postoperative days 2-7
Evaluation of Trismus	The amount of trismus was assessed by measuring the distance between the mesial corners of the right maxillary and mandibular central incisors at maximum mouth opening immediately before the operation and on the 2nd and 7th postoperative days.	preoperative and postoperative days 2-7
Evaluation of Salivary Cortisol	Before starting the impacted tooth surgery, patients spit into 1.5 ml tubes at 08:30 or 15:30 depending on their groups; 48 hours after surgery and on the 7th day, and these tubes were stored in the refrigerator at -22 degrees. The samples in these tubes were then examined with the 'Human Cor (Cortisol) ELISA Kit- ELK8526' ELISA kits with a measurement sensitivity of 1.02 ng/mL and a measurement range of 3.13-200 ng/mL.

Eligibility Module

Facility	Status	City	State	ZIP	Country	Contacts
Afyonkarahisar Health Sciences University Faculty of Dentistry, Department of Oral and Maxillofacial Surgery		Afyonkarahisar	Afyonkarahisar	03030	Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
2405122	Result	Montgomery MT, Hogg JP, Roberts DL, Redding SW. The use of glucocorticosteroids to lessen the inflammatory sequelae following third molar surgery. J Oral Maxillofac Surg. 1990 Feb;48(2):179-87. doi: 10.1016/s0278-2391(10)80207-1.
21320597	Result	Chung S, Son GH, Kim K. Circadian rhythm of adrenal glucocorticoid: its regulation and clinical implications. Biochim Biophys Acta. 2011 May;1812(5):581-91. doi: 10.1016/j.bbadis.2011.02.003. Epub 2011 Feb 12.