Molar, ThirdPhase 4NCT06452134
Evaluation the Effect of Coenzyme Q10 on Tissue Healing Process in Patients Undergoing Wisdom Tooth Extraction
A Phase 4 study testing Coenzyme Q10 100 MG Oral Tablet in people with Molar, Third and Temporomandibular Joint Disorders, run by Zahra Nejati.
Trial summary
The goal of this clinical trial is to asses the effect of Coenzyme Q10 administration in patients from any gender group who are older than 18 years old undergoing wisdom tooth extraction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Molar, Third, Temporomandibular Joint Disorders, Dry Socket
- What is being tested?
- Coenzyme Q10 100 MG Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Jul 2024to May 2025
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients older than 18 years old that require mandibular or maxillary molar, third tooth extraction as Oral and Maxillofacial surgeon's clinical diagnosis.
Who cannot join
- The patient's departure from Sanandaj
- The patient's disagreement with the study protocol
- The Patient's demise
- The patient's hospitalization for unrelated illnesses
- The patient's discontent with the care they received
- The patient's failure to show up for follow-up appointments
- The patient's sensitivity to Coenzyme Q10
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation the Effect of Coenzyme Q10 on Tissue Healing Process in Patients Undergoing Wisdom Tooth Extraction in the City of Sanandaj-Iran in 1402: a Double-blinded Clinical Trial Study
The goal of this clinical trial is to asses the effect of Coenzyme Q10 administration in patients from any gender group who are older than 18 years old undergoing wisdom tooth extraction. The main questions it aims to answer are:
does Coenzyme Q10 help with better tissue healing? does Coenzyme Q10 administration lower the prevalence of Dry socket after surgery? does Coenzyme Q10 prevent TMD (Temporomandibular disorders) while recovering from surgery? how does Coenzyme Q10 administration effect the answers to SF-36 health survey in patients? Researchers will compare Coenzyme Q10 to a placebo (a look-alike substance that contains no drug) to see if it has any effect on mentioned parameters.
Read more
Participants will:
- take coenzyme Q10 (100mg) daily for 30 days after surgery.
- will be examined and evaluated 1, 7, 14 and 30 days after completion of surgery.
- Being tested
- Coenzyme Q10 100 MG Oral Tablet, Placebo
- Keywords
- coenzyme Q10, Dry Socket, Temporomandibular Joint Disorders, Molar, Third, SF-36 health survey, Tissue healing, Tooth Extraction, GHQ-12
- Medical subject headings
- Temporomandibular Joint Disorders, Dry Socket
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coenzyme Q10 100 MG Oral TabletDrug
Also called Coenzyme Q, CoQ, CoQ10, Ubiquinone
Coenzyme Q10 oral Tablet with dosage of 100mg daily given for a period of 30 days after surgery.
PlaceboDrug
Exactly same looking agent in the form of a tablet with same size and color to CoezymeQ10 with no active property given for a period of 30 days after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | This arm of the study includes 35 of participants who will be given Coenzyme Q10 100 MG Oral Tablet for 30 days. Receives: Drug: Coenzyme Q10 100 MG Oral Tablet |
| Control group | Placebo comparator | This arm of the study includes 35 of participants who will be given Placebo ( a look-alike substance ) with same tablet form given daily for a period of 30 days after surgery. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Tissue healing
Regeneration-the replacement of damaged tissues with cells of the same type-and fibrosis-the replacement of damaged tissues with connective tissue-are the two primary processes involved in wound healing. To help in tissue healing, some cells, such as fibroblasts and vascular endothelial cells, have the ability to proliferate quickly in response to an external stimulation. Wound closure also requires non-proliferating cells, such as peripheral nervous system cells and odontoblasts. The bone that grows in to fill the space left by a tooth extraction should be similar to the surrounding healthy tissues. A lack of tissue healing is indicated by symptoms such as edema, fever, bleeding, discomfort, necrosis, exudate, flap instability, foul taste, and fistula. If trismus results from a muscle injury following an IAN Block injection, it should go away as the tissue heals.
Measured: 1, 7, 14 and 30 days after surgery
Secondary outcomes (4)
Incidence of Temporomandibular disorders
Temporomandibular disorders is a collective term for a set of disorders characterized by pain and dysfunction in the muscles and jaw joint. A specialist dentist will measure a patient's temporomandibular disorder (TMD) clinically by looking for signs of trismus, abnormal movement of the lower jaw during opening and closing or chewing, jaw dysfunction, reduced range of motion, ear pain, temporal pain, headache, bruxism, sensitivity of the muscles in the neck and shoulders, and malocclusion (such as acquired edentulism, facial asymmetry, etc.). The diagnosis of TMD is finalized if the symptoms are positive.
Measured: 1, 7, 14 and 30 days after surgery
Occurrence of Dry socket
This is a non-scientific phrase for a cavity where all or part of the bone is exposed since there isn't any bone in the days following extraction. This can happen inside the cavity or outside the occlusal environment of the cavity. Severe recurrent pain results from the patient's inability to stop the mechanical stimulation of food particles or tongue on the exposed bone, which is extremely painful to touch. A specialized physician measures it by doing a clinical examination as well as by observing the whiteness of the bone-which is empty and uncomfortable to the touch-in the extracted tooth's socket.
Measured: 1, 7, 14 and 30 days after surgery
Answers to The Short Form Health Survey-36
This tool has shown to be useful in a variety of contexts, including clinical practice, the assessment of health policies, and general security investigations. The 36-item form was created in the United States in 1992 by Ware and associates, and studies on a range of patient populations have assessed its validity and reliability. This questionnaire's topics are not restricted to any one age range, illness, or condition. By adding the results of the eight health-forming categories, the questionnaire's design aims to assess the state of health from both a physical and mental standpoint. This survey, which consists of 63 items, rates eight distinct health domains using a scoring system derived from the table found in the reference. To score the SF-36, scales are standardized with a scoring algorithm or by the SF-36v2 scoring software to obtain a score ranging from 0 to 100. Higher scores indicate better health status.
Measured: 1, 7, 14 and 30 days after surgery
Answers to The General Health Questionnaire-12
Developed in the 1970s, the General Health Questionnaire (GHQ) is regarded as a valid and dependable instrument for evaluating mental health. The most popular of the various iterations of this survey is the GHQ-12 version. It is a 12-item mental health assessment that is assessed using the table given in the reference.The scores typically used are the binary scale (0-0-1-1) and the 4-point Likert-type scale (0-1-2-3). Responses to all items are summed up to a total score ranging from 0 to 12 (binary scale) or 0 to 36 (Likert scale), with higher scores indicating more severe impairment.
Measured: 1, 7, 14 and 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study startJul 2024 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (57)Papers the sponsor has linked to this study.
- Other trials for Molar, ThirdStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zahra Nejati
- Sponsor type
- University, hospital or other
- Collaborators
- Kurdistan University of Medical Sciences
- Responsible party
- Sponsor-investigator, Zahra Nejati, Kurdistan University of Medical Sciences
- Investigators
- Zahra Nejati, Study director, Zahra Nejati, Department of oral and maxillofacial medicine, School of Dentistry, Kurdistan University of Medical Sciences, Sanandaj, Iran.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06452134
- Sponsor's protocol ID
- IR.MUK.REC.1403.030
- Status last verified
- Jun 2024
- First submitted
- 30 May 2024
- Last updated
- 11 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rafetto LK. Managing Impacted Third Molars. Oral Maxillofac Surg Clin North Am. 2015 Aug;27(3):363-71. doi: 10.1016/j.coms.2015.04.004. Epub 2015 Jun 9.
PubMed 26070801Glickman A, Karlis V. Pediatric Benign Soft Tissue Oral and Maxillofacial Pathology. Oral Maxillofac Surg Clin North Am. 2016 Feb;28(1):1-10. doi: 10.1016/j.coms.2015.07.005.
PubMed 26614696Kaner KH. Referral and Management Considerations for a Biopsy: Why Choose the Oral and Maxillofacial Surgeon. Dent Clin North Am. 2020 Jan;64(1):241-247. doi: 10.1016/j.cden.2019.08.013. Epub 2019 Oct 21.
PubMed 31735229Kiencalo A, Jamka-Kasprzyk M, Panas M, Wyszynska-Pawelec G. Analysis of complications after the removal of 339 third molars. Dent Med Probl. 2021 Jan-Mar;58(1):75-80. doi: 10.17219/dmp/127028.
PubMed 33789003Hallab L, Azzouzi A, Chami B. Quality of life after extraction of mandibular wisdom teeth: A systematic review. Ann Med Surg (Lond). 2022 Aug 21;81:104387. doi: 10.1016/j.amsu.2022.104387. eCollection 2022 Sep.
PubMed 36147052Hao M, Duan M, Yang Z, Zhou H, Li S, Xiang J, Wu H, Liu H, Chang L, Wang D, Liu W. Engineered stem cell exosomes for oral and maxillofacial wound healing. Front Bioeng Biotechnol. 2022 Oct 24;10:1038261. doi: 10.3389/fbioe.2022.1038261. eCollection 2022.
PubMed 36353739Cluis CP, Burja AM, Martin VJ. Current prospects for the production of coenzyme Q10 in microbes. Trends Biotechnol. 2007 Nov;25(11):514-21. doi: 10.1016/j.tibtech.2007.08.008.
PubMed 17935805Moon HJ, Ko WK, Han SW, Kim DS, Hwang YS, Park HK, Kwon IK. Antioxidants, like coenzyme Q10, selenite, and curcumin, inhibited osteoclast differentiation by suppressing reactive oxygen species generation. Biochem Biophys Res Commun. 2012 Feb 10;418(2):247-53. doi: 10.1016/j.bbrc.2012.01.005. Epub 2012 Jan 9.
PubMed 22252298Sifuentes-Franco S, Sanchez-Macias DC, Carrillo-Ibarra S, Rivera-Valdes JJ, Zuniga LY, Sanchez-Lopez VA. Antioxidant and Anti-Inflammatory Effects of Coenzyme Q10 Supplementation on Infectious Diseases. Healthcare (Basel). 2022 Mar 7;10(3):487. doi: 10.3390/healthcare10030487.
PubMed 35326965Li X, Zhan J, Hou Y, Hou Y, Chen S, Luo D, Luan J, Wang L, Lin D. Coenzyme Q10 Regulation of Apoptosis and Oxidative Stress in H2O2 Induced BMSC Death by Modulating the Nrf-2/NQO-1 Signaling Pathway and Its Application in a Model of Spinal Cord Injury. Oxid Med Cell Longev. 2019 Dec 12;2019:6493081. doi: 10.1155/2019/6493081. eCollection 2019.
PubMed 31915512Hargreaves I, Heaton RA, Mantle D. Disorders of Human Coenzyme Q10 Metabolism: An Overview. Int J Mol Sci. 2020 Sep 13;21(18):6695. doi: 10.3390/ijms21186695.
PubMed 32933108Moon HJ, Ko WK, Jung MS, Kim JH, Lee WJ, Park KS, Heo JK, Bang JB, Kwon IK. Coenzyme q10 regulates osteoclast and osteoblast differentiation. J Food Sci. 2013 May;78(5):H785-891. doi: 10.1111/1750-3841.12116. Epub 2013 Apr 12.
PubMed 23582186Kaushik AS, Strath LJ, Sorge RE. Dietary Interventions for Treatment of Chronic Pain: Oxidative Stress and Inflammation. Pain Ther. 2020 Dec;9(2):487-498. doi: 10.1007/s40122-020-00200-5. Epub 2020 Oct 21.
PubMed 33085012Bonakdar RA, Guarneri E. Coenzyme Q10. Am Fam Physician. 2005 Sep 15;72(6):1065-70.
PubMed 16190504Choi BS, Song HS, Kim HR, Park TW, Kim TD, Cho BJ, Kim CJ, Sim SS. Effect of coenzyme Q10 on cutaneous healing in skin-incised mice. Arch Pharm Res. 2009 Jun;32(6):907-13. doi: 10.1007/s12272-009-1613-3. Epub 2009 Jun 26.
PubMed 19557369
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation the Effect of Coenzyme Q10 on Tissue Healing Process in Patients Undergoing Wisdom Tooth Extraction in the City of Sanandaj-Iran in 1402: a Double-blinded Clinical Trial Study
- ClinicalTrials.gov ID
- NCT06452134
- Acronym / sponsor ID
- IR.MUK.REC.1403.030
- Keywords
- coenzyme Q10, Dry Socket, Temporomandibular Joint Disorders, Molar, Third, SF-36 health survey, Tissue healing, Tooth Extraction, GHQ-12
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Zahra NejatiUniversity, hospital or other
- Collaborators
- Kurdistan University of Medical Sciences
- Study start
- Jul 2024 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 11 Jun 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.
The goal of this clinical trial is to asses the effect of Coenzyme Q10 administration in patients from any gender group who are older than 18 years old undergoing wisdom tooth extraction. The main questions it aims to answer are:
does Coenzyme Q10 help with better tissue healing? does Coenzyme Q10 administration lower the prevalence of Dry socket after surgery? does Coenzyme Q10 prevent TMD (Temporomandibular disorders) while recovering from surgery? how does Coenzyme Q10 administration effect the answers to SF-36 health survey in patients? Researchers will compare Coenzyme Q10 to a placebo (a look-alike substance that contains no drug) to see if it has any effect on mentioned parameters.
Participants will:
- take coenzyme Q10 (100mg) daily for 30 days after surgery.
- will be examined and evaluated 1, 7, 14 and 30 days after completion of surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Drug: Coenzyme Q10 100 MG Oral TabletThis arm of the study includes 35 of participants who will be given Coenzyme Q10 100 MG Oral Tablet for 30 days. |
| Control group | Placebo comparator | Drug: PlaceboThis arm of the study includes 35 of participants who will be given Placebo ( a look-alike substance ) with same tablet form given daily for a period of 30 days after surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients older than 18 years old that require mandibular or maxillary molar, third tooth extraction as Oral and Maxillofacial surgeon's clinical diagnosis.
Key exclusion criteria (7 listed)
- The patient's departure from Sanandaj
- The patient's disagreement with the study protocol
- The Patient's demise
- The patient's hospitalization for unrelated illnesses
- The patient's discontent with the care they received
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 |
|---|---|---|
| Coenzyme Q10 100 MG Oral TabletAlso: Coenzyme Q, CoQ, CoQ10, UbiquinoneCoenzyme Q10 oral Tablet with dosage of 100mg daily given for a period of 30 days after surgery. | Drug | Intervention group |
| PlaceboExactly same looking agent in the form of a tablet with same size and color to CoezymeQ10 with no active property given for a period of 30 days after surgery. | Drug | Control group |
Primary outcome
Rate of Tissue healing
Time frame: 1, 7, 14 and 30 days after surgery
Regeneration-the replacement of damaged tissues with cells of the same type-and fibrosis-the replacement of damaged tissues with connective tissue-are the two primary processes involved in wound healing. To help in tissue healing, some cells, such as fibroblasts and vascular endothelial cells, have the ability to proliferate quickly in response to an external stimulation. Wound closure also requires non-proliferating cells, such as peripheral nervous system cells and odontoblasts. The bone that grows in to fill the space left by a tooth extraction should be similar to the surrounding healthy tissues. A lack of tissue healing is indicated by symptoms such as edema, fever, bleeding, discomfort, necrosis, exudate, flap instability, foul taste, and fistula. If trismus results from a muscle injury following an IAN Block injection, it should go away as the tissue heals.
4 secondary outcomes
Incidence of Temporomandibular disorders
Time frame: 1, 7, 14 and 30 days after surgery
Occurrence of Dry socket
Time frame: 1, 7, 14 and 30 days after surgery
Answers to The Short Form Health Survey-36
Time frame: 1, 7, 14 and 30 days after surgery
Answers to The General Health Questionnaire-12
Time frame: 1, 7, 14 and 30 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
- Results publication: PubMed 26070801Rafetto LK. Managing Impacted Third Molars. Oral Maxillofac Surg Clin North Am. 2015 Aug;27(3):363-71. doi: 10.1016/j.coms.2015.04.004. Epub 2015 Jun 9.
- Results publication: PubMed 26614696Glickman A, Karlis V. Pediatric Benign Soft Tissue Oral and Maxillofacial Pathology. Oral Maxillofac Surg Clin North Am. 2016 Feb;28(1):1-10. doi: 10.1016/j.coms.2015.07.005.
- Results publication: PubMed 31735229Kaner KH. Referral and Management Considerations for a Biopsy: Why Choose the Oral and Maxillofacial Surgeon. Dent Clin North Am. 2020 Jan;64(1):241-247. doi: 10.1016/j.cden.2019.08.013. Epub 2019 Oct 21.
- Results publication: PubMed 33789003Kiencalo A, Jamka-Kasprzyk M, Panas M, Wyszynska-Pawelec G. Analysis of complications after the removal of 339 third molars. Dent Med Probl. 2021 Jan-Mar;58(1):75-80. doi: 10.17219/dmp/127028.
- Results publication: PubMed 36147052Hallab L, Azzouzi A, Chami B. Quality of life after extraction of mandibular wisdom teeth: A systematic review. Ann Med Surg (Lond). 2022 Aug 21;81:104387. doi: 10.1016/j.amsu.2022.104387. eCollection 2022 Sep.
- Results publication: PubMed 36353739Hao M, Duan M, Yang Z, Zhou H, Li S, Xiang J, Wu H, Liu H, Chang L, Wang D, Liu W. Engineered stem cell exosomes for oral and maxillofacial wound healing. Front Bioeng Biotechnol. 2022 Oct 24;10:1038261. doi: 10.3389/fbioe.2022.1038261. eCollection 2022.
- Results publication: PubMed 17935805Cluis CP, Burja AM, Martin VJ. Current prospects for the production of coenzyme Q10 in microbes. Trends Biotechnol. 2007 Nov;25(11):514-21. doi: 10.1016/j.tibtech.2007.08.008.
- Results publication: PubMed 22252298Moon HJ, Ko WK, Han SW, Kim DS, Hwang YS, Park HK, Kwon IK. Antioxidants, like coenzyme Q10, selenite, and curcumin, inhibited osteoclast differentiation by suppressing reactive oxygen species generation. Biochem Biophys Res Commun. 2012 Feb 10;418(2):247-53. doi: 10.1016/j.bbrc.2012.01.005. Epub 2012 Jan 9.
- Results publication: PubMed 35326965Sifuentes-Franco S, Sanchez-Macias DC, Carrillo-Ibarra S, Rivera-Valdes JJ, Zuniga LY, Sanchez-Lopez VA. Antioxidant and Anti-Inflammatory Effects of Coenzyme Q10 Supplementation on Infectious Diseases. Healthcare (Basel). 2022 Mar 7;10(3):487. doi: 10.3390/healthcare10030487.
- Results publication: PubMed 31915512Li X, Zhan J, Hou Y, Hou Y, Chen S, Luo D, Luan J, Wang L, Lin D. Coenzyme Q10 Regulation of Apoptosis and Oxidative Stress in H2O2 Induced BMSC Death by Modulating the Nrf-2/NQO-1 Signaling Pathway and Its Application in a Model of Spinal Cord Injury. Oxid Med Cell Longev. 2019 Dec 12;2019:6493081. doi: 10.1155/2019/6493081. eCollection 2019.
- Results publication: PubMed 32933108Hargreaves I, Heaton RA, Mantle D. Disorders of Human Coenzyme Q10 Metabolism: An Overview. Int J Mol Sci. 2020 Sep 13;21(18):6695. doi: 10.3390/ijms21186695.
- Results publication: PubMed 23582186Moon HJ, Ko WK, Jung MS, Kim JH, Lee WJ, Park KS, Heo JK, Bang JB, Kwon IK. Coenzyme q10 regulates osteoclast and osteoblast differentiation. J Food Sci. 2013 May;78(5):H785-891. doi: 10.1111/1750-3841.12116. Epub 2013 Apr 12.
- 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.
Zahra Nejati study director
Zahra Nejati, Department of oral and maxillofacial medicine, School of Dentistry, Kurdistan University of Medical Sciences, Sanandaj, Iran.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Coenzyme Q10 100 MG Oral Tablet in people with Molar, Third and Temporomandibular Joint Disorders, run by Zahra Nejati.
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 1 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zahra Nejati (+989220243892, Znregina@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Tissue healing (time frame: 1, 7, 14 and 30 days after surgery). 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 NCT06452134, which also lists 57 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 11 Jun 2024.