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

NCT06452134 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: IR.MUK.REC.1403.030
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Molar, Third; Temporomandibular Joint Disorders; Dry Socket; Coenzyme Q10

Keywords

coenzyme Q10; Dry Socket; Temporomandibular Joint Disorders; Molar, Third; SF-36 health survey; Tissue healing; Tooth Extraction; GHQ-12

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Incidence of Temporomandibular disorders

  1, 7, 14 and 30 days after surgery

• Occurrence of Dry socket

  1, 7, 14 and 30 days after surgery

• Answers to The Short Form Health Survey-36

  1, 7, 14 and 30 days after surgery

• Answers to The General Health Questionnaire-12

  1, 7, 14 and 30 days after surgery

Study Arms (2)

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.

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.

Drug: Placebo

Interventions

Coenzyme Q10 100 MG Oral Tablet DRUG

Coenzyme Q10 oral Tablet with dosage of 100mg daily given for a period of 30 days after surgery.

Also known as: Coenzyme Q, CoQ, CoQ10, Ubiquinone, Ubiquinone-Q10, Ubidecarenone, Vitamin Q10

Intervention group

Placebo DRUG

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.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

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MeSH Terms

Conditions

Temporomandibular Joint Disorders; Dry Socket

Interventions

coenzyme Q10; Tablets; Ubiquinone

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Mouth Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations; Benzoquinones; Quinones; Organic Chemicals; Coenzymes; Enzymes and Coenzymes

Study Officials

• Zahra Nejati

  Zahra Nejati, Department of oral and maxillofacial medicine, School of Dentistry, Kurdistan University of Medical Sciences, Sanandaj, Iran.

  STUDY DIRECTOR

Central Study Contacts

Zahra Nejati

CONTACT

+989220243892; Znregina@gmail.com

Babak Ghadirzadeh

CONTACT

+989355795670; Ghadirzadeh.babak@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Zahra Nejati, Dental student, Department of oral and maxillofacial medicine, School of Dentistry, Kurdistan University of Medical Sciences, Sanandaj, Iran.

Study Record Dates

• First Submitted: May 30, 2024
• First Posted: June 11, 2024
• Study Start: July 1, 2024
• Primary Completion: September 1, 2024
• Study Completion: May 1, 2025
• Last Updated: June 11, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share