Comparison of Salivary Parameters in Patients Receiving CoQ10 and Vitamin E Supplementation

Periodontal Diseases Clinical Trial

Official title:

Comparison of Salivary Markers in Patients With Initial Chronic Periodontitis After Non-surgical Periodontal Treatment With CoQ10 Supplementation With Vitamin E

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06373848
• Other study ID #: 346
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 20, 2024
• Est. completion date: September 15, 2024

Study information

• Verified date: May 2024
• Source: Islamic Azad University, Tehran
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Comparison of salivary markers in patients with Initial chronic periodontitis after non-surgical periodontal treatment with CoQ10 supplementation with vitamin E

Description:

This research was structured as a double-blind, randomized clinical trial aimed at assessing the effectiveness of CoQ10 and Vitamin E supplements on periodontal health in patients with chronic periodontitis. A total of 75 patients from the Department of Periodontics at Broujerd Dental School of the Islamic Azad University of Medical Sciences were chosen for the study. Before the commencement of the trial, various clinical periodontal parameters such as plaque index, bleeding on probing, gingival index, probing depth, and clinical attachment level were measured in six different areas of the tooth surface. Subsequently, scaling and root planning were carried out, and oral hygiene practices were enhanced for all participants. The participants were then randomly divided into three groups: Group A received 30 mg of CoQ10, Group B was provided with 400 mg of Vitamin E supplements daily, and Group C did not receive any medication. After two months, the clinical periodontal parameters were reevaluated. Furthermore, to compare the total antioxidant capacity in saliva before and after the administration of these supplements, as well as in patients who did not receive any medication, 2 ml of non-stimulated saliva was collected from each participant at the beginning and end of the study for analysis using UV-spectrophotometric methods. The selection criteria for eligible participants in this study were also clearly defined.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 85
• Est. completion date: September 15, 2024
• Est. primary completion date: May 20, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 28 Years to 35 Years

Eligibility

Inclusion Criteria:

healthy individuals, between the ages of 28 and 35, there is a presence of chronic initial periodontal disease, now categorized as Stage-I, with a maximum pocket depth of 5 mm, specifically affecting the mandibular molar teeth in every quadrant.

Exclusion Criteria:

Conditions that may affect orthodontic treatments include systemic diseases, ongoing orthodontic treatments, pregnancy and breastfeeding, and the use of medications that can impact the periodontium, such as antibiotics, within the past 6 months. Additionally, recent malignancy, radiotherapy, or chemotherapy within the past 5 years can also have an impact. It is important to consider factors such as plaque index and bleeding scores, which should be below 25%, as well as any history of periodontal surgery at the desired treatment site within the past 6 months. Furthermore, the use of medicinal supplements within the past 6 months and cigarette smoking or tobacco use should also be taken into account.

Eligibility Criteria:

The study population consisted of 80 eligible individuals who were enrolled in this research project, which was specifically designed to conduct Randomized Double-Blind Clinical Trials.

Related Conditions & MeSH terms

• Periodontal Diseases

Intervention

Drug:
• Receive 30 mg of Coq10
A total of 75 individuals diagnosed with chronic periodontitis were selected for this study. These participants were randomly assigned to two different groups. The purpose of the study was to measure the periodontal parameters of the two molars adjacent to the mandible using a periodontal probe. All of the patients received scaling and root planing (SRP) as part of their treatment. However, the treatment groups differed in terms of the supplements they received. Group A was given a daily dose of Coq10 at 30 mg, while Group B received a daily dose of Vitamin E at 400 mg; Furthermore, group C did not receive any supplements. The periodontal examination involved a total of 300 teeth across the three groups. In addition to this, 2 ml of unstimulated saliva was collected from each patient both before and after 2 months. The purpose of collecting the saliva samples was to evaluate the total antioxidant capacity and determine if there were any changes over time.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Amirhossein Farahmand	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Islamic Azad University, Tehran

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Antioxidant capacity (TAC) of saliva	UV-spectrophotometry was employed to assess the overall antioxidant capacity in saliva before and after the consumption of these supplements, as well as in individuals who were not administered any medication. A total of 2 ml of non-stimulated saliva was collected from each participant at the commencement and conclusion of the study for analysis using UV-spectrophotometric techniques. Additionally, the selection of eligible participants for dis study was determined based on the following criteria.	3 months
Secondary	Bleeding on probing	The evaluation of the bleeding index will involve the utilization of a periodontal probe, which will be used to compare the results with other groups at the beginning and end of the study.	3 months