Wisdom TeethNCT06610383
Evaluation of the Effect of Circadian Rhythm of Adrenal Glucocorticoids After Third Molar Extraction
An observational study of Wisdom Teeth, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Wisdom Teeth
- What is being tested?
- Surgical extraction of wisdom teeth in the morning and Surgical extraction of wisdom teeth in the afternoon
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Nov 2021to 1 Nov 2023
- How long will I take part?
- 7 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients living in Afyonkarahisar province and applying for extraction of bilaterally impacted wisdom teeth
Who may be able to join
- 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,
Show all 9Show fewer
- 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.
Who cannot join
- 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,
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Afyonkarahisar Health Sciences University Faculty of Dentistry, Department of Oral and Maxillofacial Surgery
Afyonkarahisar, Afyonkarahisar, 03030
About this study
Official title: Effect of Circadian Rhythm of Adrenal Glucocorticoid on Pain, Swelling, and Trismus After Surgical Removal of Mandibular Third Molars
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.
Read the 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.
- Conditions
- Wisdom Teeth
- Being tested
- Surgical extraction of wisdom teeth in the morning, Surgical extraction of wisdom teeth in the afternoon
- Keywords
- wisdom teeth, circadian rhythm, steroid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical extraction of wisdom teeth in the morningProcedure or surgery
The patients in this group underwent impacted tooth surgery at 08:30 in the morning.
Surgical extraction of wisdom teeth in the afternoonProcedure or surgery
Impacted tooth surgery was performed on the patients in this group at 15:30.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Surgical extraction of wisdom teeth in the afternoon |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: preoperative and postoperative days 2-7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start11 Nov 2021
- Primary completion1 May 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Wisdom TeethStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Afyonkarahisar Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammet Yasin Pektaş, Afyonkarahisar Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06610383
- Sponsor's protocol ID
- 21.KARİYER.008
- Status last verified
- Sep 2024
- First submitted
- 20 Sep 2024
- Last updated
- 24 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 2405122Chung 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.
PubMed 21320597Balbo 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.
PubMed 20628523
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Circadian Rhythm of Adrenal Glucocorticoid on Pain, Swelling, and Trismus After Surgical Removal of Mandibular Third Molars
- ClinicalTrials.gov ID
- NCT06610383
- Acronym / sponsor ID
- 21.KARİYER.008
- Conditions
- Wisdom Teeth
- Keywords
- wisdom teeth, circadian rhythm, steroid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Afyonkarahisar Health Sciences UniversityUniversity, hospital or other
- Study start
- 11 Nov 2021 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 24 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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\'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.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Target follow-up
- 7 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (08:30 group (n=20)) | – | Procedure: Surgical extraction of wisdom teeth in the morningPatients 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. |
| Group 2 (15:30 group (n=20)) | – | Procedure: Surgical extraction of wisdom teeth in the afternoonPatients 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. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients living in Afyonkarahisar province and applying for extraction of bilaterally impacted wisdom teeth
Key inclusion criteria (9 listed)
- 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,
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical extraction of wisdom teeth in the morningThe patients in this group underwent impacted tooth surgery at 08:30 in the morning. | Procedure or surgery | Group 1 (08:30 group (n=20)) |
| Surgical extraction of wisdom teeth in the afternoonImpacted tooth surgery was performed on the patients in this group at 15:30. | Procedure or surgery | Group 2 (15:30 group (n=20)) |
Primary outcome
Pain Assessment
Time frame: preoperative and postoperative days 2-7
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.
Evaluation of Edema
Time frame: preoperative and postoperative days 2-7
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.
Evaluation of Trismus
Time frame: preoperative and postoperative days 2-7
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.
Evaluation of Salivary Cortisol
Time frame: preoperative and postoperative days 2-7
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2024.
- Results publication: PubMed 2405122Montgomery 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.
- Results publication: PubMed 21320597Chung 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.
- Results publication: PubMed 20628523Balbo 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wisdom Teeth, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Assessment (time frame: preoperative and postoperative days 2-7). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06610383, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2024.