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

Phase 4

Not yet recruiting

• Conditions: Molar, Third; Dry Socket; Coenzyme Q10; Temporomandibular Joint Disorders
• Interventions: Drug: Coenzyme Q10 100 MG Oral Tablet; Drug: Placebo

• Registration Number: NCT06452134
• Lead Sponsor: Zahra Nejati

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-05-30
• Status Verified: 2024-06
• Study First Submitted QC: 2024-06-09
• Last Update Submitted: 2024-06-09
• Study First Posted: 2024-06-11
• Last Update Posted: 2024-06-11
• Study Start: 2024-07
• Primary Completion: 2024-09
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Coenzyme Q10 100 MG Oral Tablet	This arm of the study includes 35 of participants who will be given Coenzyme Q10 100 MG Oral Tablet for 30 days.
Control group	Placebo	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.

Primary Outcome Measures

Name	Time	Method
Rate of Tissue healing	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.

Secondary Outcome Measures

Name	Time	Method
Incidence of Temporomandibular disorders	1, 7, 14 and 30 days after surgery	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.
Occurrence of Dry socket	1, 7, 14 and 30 days after surgery	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.
Answers to The Short Form Health Survey-36	1, 7, 14 and 30 days after surgery	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.
Answers to The General Health Questionnaire-12	1, 7, 14 and 30 days after surgery	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.