Evaluation of the Effect of Circadian Rhythm of Adrenal Glucocorticoids After Third Molar Extraction

NCT06610383 | Completed

• 1 other identifier: 21.KARİYER.008
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Wisdom Teeth

Keywords

wisdom teeth; circadian rhythm; steroid

Outcome Measures

Primary Outcomes (4)

• 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.

  preoperative and postoperative days 2-7

Study Arms (2)

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

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))

Surgical extraction of wisdom teeth in the afternoon PROCEDURE

Impacted tooth surgery was performed on the patients in this group at 15:30.

Group 2 (15:30 group (n=20))

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients living in Afyonkarahisar province and applying for extraction of bilaterally impacted wisdom teeth

You may qualify if:

• Patients with bilateral wisdom teeth in the lower jaw and similar impacted positions
• 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,
• 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,
• Patients with good oral hygiene,
• Patients who can comply with the scales in the questionnaire form,
• Patients who have not had surgery on their lower wisdom teeth before,
• Patients who have not used corticosteroids and anticonvulsant drugs,
• Patients who have no active caries and pulpal lesions,
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Afyonkarahisar Health Sciences University: lead

Study Sites (1)

Afyonkarahisar Health Sciences University Faculty of Dentistry, Department of Oral and Maxillofacial Surgery

Afyonkarahisar, Afyonkarahisar, 03030, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 2405122 BACKGROUND

• 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.

  PMID: 21320597 BACKGROUND

• 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.

  PMID: 20628523 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Asistant

Study Record Dates

• First Submitted: September 20, 2024
• First Posted: September 24, 2024
• Study Start: November 11, 2021
• Primary Completion: May 1, 2023
• Study Completion: November 1, 2023
• Last Updated: September 24, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)