Clinical trial NCT06610383: Evaluation of the Effect of Circadian Rhythm of Adrenal Glucocorticoids After Third Molar Extraction
Official title: Effect of Circadian Rhythm of Adrenal Glucocorticoid on Pain, Swelling, and Trismus After Surgical Removal of Mandibular Third Molars
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Wisdom Teeth
Keywords: wisdom teeth
circadian rhythm
steroid
Lead sponsor: Afyonkarahisar Health Sciences University
Sponsor class: OTHER
First posted: 2024-09-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients living in Afyonkarahisar province and applying for extraction of bilaterally impacted wisdom teeth

Brief summary: This study aimed to investigate the effects of wisdom tooth surgery performed at different times of the day on pain, swelling and trismus based on changes in the circadian rhythm in the adrenal glands in patients aged between 18-25 years who applied to the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Afyonkarahisar Health Sciences University with complaints of pain and swelling due to wisdom teeth.

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\&#39;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\&#39; personal information to conduct the study and statistical analyses, but the participants\&#39; identities will be kept confidential. Ethics committees or official authorities may review the participants\&#39; 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.

Eligibility criteria: Inclusion Criteria:

1. Patients with bilateral wisdom teeth in the lower jaw and similar impacted positions
2. Patients with no history of trauma to the head and neck region, no congenital deformities, no degenerative joint disease, patients between the ages of 18 and 25,
3. Patients who have not received any treatment for the adrenal gland in the last 6 months, patients who have not used antidepressant medication in the last 6 months, patients who have no cardiovascular disease, thyroid disease, diabetes, hypertension, renal failure, isolated muscle disease, rheumatological and neurological disease, and patients who have no known psychiatric disorder,
4. Patients with good oral hygiene,
5. Patients who can comply with the scales in the questionnaire form,
6. Patients who have not had surgery on their lower wisdom teeth before,
7. Patients who have not used corticosteroids and anticonvulsant drugs,
8. Patients who have no active caries and pulpal lesions,
9. Patients who can fill out the questionnaire forms on their own. 10) Patients who have not received radiotherapy in the head and neck region and who do not use drugs that may cause MRONJ.

Exclusion Criteria:

1. Patients who had undergone surgical treatment for their wisdom teeth before the study,
2. Patients with serious systemic diseases and those taking medication,
3. Pregnant and breastfeeding women,
4. Individuals using removable dentures,
5. Those receiving psychiatric treatment and those taking medication,

7. Those with a history of heart infarction, 8. Patients using pacemakers, 9. Individuals with epilepsy and neurological disorders, 10. Patients with habits such as alcohol and drug addiction, 11. Patients with advanced periodontitis, 12. Patients undergoing orthodontic treatment and having unstable occlusions, 13. Patients who have received radiotherapy and those taking medications that may cause MRI.

Primary outcomes:
measure: Pain Assessment
timeFrame: preoperative and postoperative days 2-7
measure: Evaluation of Edema
timeFrame: preoperative and postoperative days 2-7
measure: Evaluation of Trismus
timeFrame: preoperative and postoperative days 2-7
measure: Evaluation of Salivary Cortisol
timeFrame: preoperative and postoperative days 2-7
Secondary outcomes:
Other outcomes:
Locations:
city: Afyonkarahisar
country: Turkey
facility: Afyonkarahisar Health Sciences University Faculty of Dentistry, Department of Oral and Maxillofacial Surgery
Study officials:
References:
citation: 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.
citation: 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.
citation: Balbo M, Leproult R, Van Cauter E. Impact of sleep and its disturbances on hypothalamo-pituitary-adrenal axis activity. Int J Endocrinol. 2010;2010:759234. doi: 10.1155/2010/759234. Epub 2010 Jun 9.