Evaluation the Effect of Coenzyme Q10 on Tissue Healing Process in Patients Undergoing Wisdom Tooth Extraction

Temporomandibular Joint Disorders Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06452134
• Other study ID #: IR.MUK.REC.1403.030
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: July 2024
• Est. completion date: May 2025

Study information

• Verified date: June 2024
• Source: Kurdistan University of Medical Sciences
• Contact: Zahra Nejati
• Phone: +989220243892
• Email: Znregina[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: May 2025
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients older than 18 years old that require mandibular or maxillary molar, third tooth extraction as Oral and Maxillofacial surgeon's clinical diagnosis.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Coenzyme Q10
• Dry Socket
• Joint Diseases
• Molar, Third
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

Drug:
• Coenzyme Q10 100 MG Oral Tablet
Coenzyme Q10 oral Tablet with dosage of 100mg daily given for a period of 30 days after surgery.
• Placebo
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.

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
Zahra Nejati	Babak Ghadirzadeh, medical student, Kurdistan university of medical sciences, Hady Mohammadi, Director of oral and maxillofacial surgery department, school of dentistry, Kurdistan university of medical sciences, Kurdistan University of Medical Sciences, Yousef Moradi, Assistant professor, Department of epidemiology and biostatistics, Kurdistan university of medical sciences

References & Publications (56)

Abdelkader HA, Rashed LA, Assaad E, Saleh MA. Serum and tissue levels of coenzyme Q10 in pemphigus vulgaris. J Cosmet Dermatol. 2022 Jul;21(7):3002-3006. doi: 10.1111/jocd.14511. Epub 2021 Oct 3. — View Citation

Al Saadi T, Assaf Y, Farwati M, Turkmani K, Al-Mouakeh A, Shebli B, Khoja M, Essali A, Madmani ME. Coenzyme Q10 for heart failure. Cochrane Database Syst Rev. 2021 Feb 3;(2)(2):CD008684. doi: 10.1002/14651858.CD008684.pub3. — View Citation

Al-Qudah AA, Bani Younis HAB, Awawdeh LA, Daud A. Root and canal morphology of third molar teeth. Sci Rep. 2023 Apr 27;13(1):6901. doi: 10.1038/s41598-023-34134-7. — View Citation

Althunian TA, de Boer A, Groenwold RHH, Klungel OH. Defining the noninferiority margin and analysing noninferiority: An overview. Br J Clin Pharmacol. 2017 Aug;83(8):1636-1642. doi: 10.1111/bcp.13280. Epub 2017 Apr 6. — View Citation

Bailey E, Kashbour W, Shah N, Worthington HV, Renton TF, Coulthard P. Surgical techniques for the removal of mandibular wisdom teeth. Cochrane Database Syst Rev. 2020 Jul 26;7(7):CD004345. doi: 10.1002/14651858.CD004345.pub3. — View Citation

Berger VW, Bour LJ, Carter K, Chipman JJ, Everett CC, Heussen N, Hewitt C, Hilgers RD, Luo YA, Renteria J, Ryeznik Y, Sverdlov O, Uschner D; Randomization Innovative Design Scientific Working Group. A roadmap to using randomization in clinical trials. BMC — View Citation

Bonakdar RA, Guarneri E. Coenzyme Q10. Am Fam Physician. 2005 Sep 15;72(6):1065-70. — View Citation

Bowe DC, Rogers S, Stassen LF. The management of dry socket/alveolar osteitis. J Ir Dent Assoc. 2011 Dec-2012 Jan;57(6):305-10. — View Citation

Brussow H. What is health? Microb Biotechnol. 2013 Jul;6(4):341-8. doi: 10.1111/1751-7915.12063. Epub 2013 May 6. — View Citation

Choi 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. — View Citation

Cluis 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. — View Citation

Cohen M, Quintner J, van Rysewyk S. Reconsidering the International Association for the Study of Pain definition of pain. Pain Rep. 2018 Mar 5;3(2):e634. doi: 10.1097/PR9.0000000000000634. eCollection 2018 Mar. — View Citation

Covani U, Barone A, Cornelini R, Crespi R. Soft tissue healing around implants placed immediately after tooth extraction without incision: a clinical report. Int J Oral Maxillofac Implants. 2004 Jul-Aug;19(4):549-53. — View Citation

Dean E. Anxiety. Nurs Stand. 2016 Jul 13;30(46):15. doi: 10.7748/ns.30.46.15.s17. — View Citation

Dodson TB, Susarla SM. Impacted wisdom teeth. BMJ Clin Evid. 2014 Aug 29;2014:1302. — View Citation

Dolens Eda S, Nakai FV, Santos Parizi JL, Alborghetti Nai G. Cytopathology: a useful technique for diagnosing oral lesions?: a systematic literature review. Diagn Cytopathol. 2013 Jun;41(6):505-14. doi: 10.1002/dc.22875. Epub 2012 May 30. — View Citation

Doty RL. Systemic diseases and disorders. Handb Clin Neurol. 2019;164:361-387. doi: 10.1016/B978-0-444-63855-7.00021-6. — View Citation

Esian D, Bica CI, Stoica OE, Dako T, Vlasa A, Bud ES, Salcudean D, Beresescu L. Prevalence and Manifestations of Dental Ankylosis in Primary Molars Using Panoramic X-rays: A Cross-Sectional Study. Children (Basel). 2022 Aug 8;9(8):1188. doi: 10.3390/child — View Citation

Fry RR, Patidar DC, Goyal S, Malhotra A. Proximity of maxillary posterior teeth roots to maxillary sinus and adjacent structures using Denta scan(R). Indian J Dent. 2016 Sep;7(3):126-130. doi: 10.4103/0975-962X.189339. — View Citation

Gauer RL, Semidey MJ. Diagnosis and treatment of temporomandibular disorders. Am Fam Physician. 2015 Mar 15;91(6):378-86. — View Citation

Ghasemi S, Torab Z, Shirmohammadi A, Babaloo A, Johari R, Farhadi F, Mobasseri M, Mohammadi H. Evaluation of the effect of coenzyme Q10 supplementation along with scaling and root planing (SRP) on periodontal and gingival indices in controlled diabetic pa — View Citation

Glickman 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. — View Citation

Gulsen I, Ak H, Colcimen N, Alp HH, Akyol ME, Demir I, Atalay T, Balahroglu R, Ragbetli MC. Neuroprotective Effects of Thymoquinone on the Hippocampus in a Rat Model of Traumatic Brain Injury. World Neurosurg. 2016 Feb;86:243-9. doi: 10.1016/j.wneu.2015.0 — View Citation

Hallab 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. — View Citation

Hao 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. — View Citation

Hargreaves 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. — View Citation

Kaner 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. — View Citation

Kaushik 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. — View Citation

Keselman HJ, Algina J, Kowalchuk RK. The analysis of repeated measures designs: a review. Br J Math Stat Psychol. 2001 May;54(Pt 1):1-20. doi: 10.1348/000711001159357. — View Citation

Kiencalo 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. — View Citation

Ko KI, Sculean A, Graves DT. Diabetic wound healing in soft and hard oral tissues. Transl Res. 2021 Oct;236:72-86. doi: 10.1016/j.trsl.2021.05.001. Epub 2021 May 13. — View Citation

Lachin JM, Matts JP, Wei LJ. Randomization in clinical trials: conclusions and recommendations. Control Clin Trials. 1988 Dec;9(4):365-74. doi: 10.1016/0197-2456(88)90049-9. — View Citation

Li 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. Ox — View Citation

List T, Jensen RH. Temporomandibular disorders: Old ideas and new concepts. Cephalalgia. 2017 Jun;37(7):692-704. doi: 10.1177/0333102416686302. Epub 2017 Jan 9. — View Citation

Mamoun J. Dry Socket Etiology, Diagnosis, and Clinical Treatment Techniques. J Korean Assoc Oral Maxillofac Surg. 2018 Apr;44(2):52-58. doi: 10.5125/jkaoms.2018.44.2.52. Epub 2018 Apr 25. — View Citation

Manzar H, Abdulhussein D, Yap TE, Cordeiro MF. Cellular Consequences of Coenzyme Q10 Deficiency in Neurodegeneration of the Retina and Brain. Int J Mol Sci. 2020 Dec 6;21(23):9299. doi: 10.3390/ijms21239299. — View Citation

Marini L, Rojas MA, Sahrmann P, Aghazada R, Pilloni A. Early Wound Healing Score: a system to evaluate the early healing of periodontal soft tissue wounds. J Periodontal Implant Sci. 2018 Oct 24;48(5):274-283. doi: 10.5051/jpis.2018.48.5.274. eCollection — View Citation

Masciocchi E, Maltais M, El Haddad K, Virecoulon Giudici K, Rolland Y, Vellas B, de Souto Barreto P. Defining Vitality Using Physical and Mental Well-Being Measures in Nursing Homes: A Prospective Study. J Nutr Health Aging. 2020;24(1):37-42. doi: 10.1007 — View Citation

Mehrotra N, Singh S. Periodontitis. 2023 May 1. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK541126/ — View Citation

Mencucci R, Favuzza E, Boccalini C, Lapucci A, Felici R, Resta F, Chiarugi A, Cavone L. CoQ10-containing eye drops prevent UVB-induced cornea cell damage and increase cornea wound healing by preserving mitochondrial function. Invest Ophthalmol Vis Sci. 20 — View Citation

Miloro M, DaBell J. Radiographic proximity of the mandibular third molar to the inferior alveolar canal. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2005 Nov;100(5):545-9. doi: 10.1016/j.tripleo.2005.03.009. — View Citation

Montazeri A, Goshtasebi A, Vahdaninia M, Gandek B. The Short Form Health Survey (SF-36): translation and validation study of the Iranian version. Qual Life Res. 2005 Apr;14(3):875-82. doi: 10.1007/s11136-004-1014-5. — View Citation

Moon 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 — View Citation

Moon 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. — View Citation

Newland JA. How do you define age? Nurse Pract. 2014 Jul 13;39(7):6. doi: 10.1097/01.NPR.0000450740.92453.2b. No abstract available. — View Citation

Pippi R. Post-Surgical Clinical Monitoring of Soft Tissue Wound Healing in Periodontal and Implant Surgery. Int J Med Sci. 2017 Jul 18;14(8):721-728. doi: 10.7150/ijms.19727. eCollection 2017. — View Citation

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. — View Citation

Reale C, Invernizzi F, Panteghini C, Garavaglia B. Genetics, sex, and gender. J Neurosci Res. 2023 May;101(5):553-562. doi: 10.1002/jnr.24945. Epub 2021 Sep 9. — View Citation

Riley RD, Ensor J, Snell KIE, Harrell FE Jr, Martin GP, Reitsma JB, Moons KGM, Collins G, van Smeden M. Calculating the sample size required for developing a clinical prediction model. BMJ. 2020 Mar 18;368:m441. doi: 10.1136/bmj.m441. No abstract availabl — View Citation

Sakpal TV. Sample size estimation in clinical trial. Perspect Clin Res. 2010 Apr;1(2):67-9. — View Citation

Sifuentes-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: 10.33 — View Citation

Unwerawattana W. Common symptoms and type of impacted molar tooth in King Chulalongkorn Memorial Hospital. J Med Assoc Thai. 2006 Sep;89 Suppl 3:S134-9. — View Citation

van Lummel RC, Walgaard S, Pijnappels M, Elders PJ, Garcia-Aymerich J, van Dieen JH, Beek PJ. Physical Performance and Physical Activity in Older Adults: Associated but Separate Domains of Physical Function in Old Age. PLoS One. 2015 Dec 2;10(12):e0144048 — View Citation

Yaseen SM, Naik S, Uloopi KS. Ectopic eruption - A review and case report. Contemp Clin Dent. 2011 Jan;2(1):3-7. doi: 10.4103/0976-237X.79289. — View Citation

Zhong B. How to calculate sample size in randomized controlled trial? J Thorac Dis. 2009 Dec;1(1):51-4. — View Citation

Zwahlen RA, Cheung LK, Zheng LW, Chow RL, Li T, Schuknecht B, Gratz KW, Weber FE. Comparison of two resorbable membrane systems in bone regeneration after removal of wisdom teeth: a randomized-controlled clinical pilot study. Clin Oral Implants Res. 2009 — View Citation

* Note: There are 56 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1, 7, 14 and 30 days after surgery
Secondary	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.	1, 7, 14 and 30 days after surgery
Secondary	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.	1, 7, 14 and 30 days after surgery
Secondary	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.	1, 7, 14 and 30 days after surgery
Secondary	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.	1, 7, 14 and 30 days after surgery