Non-surgical Treatment of Chronic Periodontitis With an Adjunctive Vitamin E and Coenzyme Q10 Supplementation

The Impact of Vitamin E and CoQ10 Supplements as an Adjunctive Non-surgical Periodontal Therapy on Chronic Periodontitis and Salivary Markers.

Non-surgical treatment of chronic periodontitis with vitamin E and coenzyme Q10 supplementation

Study Overview

• Status: Enrolling by invitation
• Conditions: Periodontal Diseases
• Intervention / Treatment: Drug: Receive 30 mg of Coq10

Detailed Description

This research was structured as a double-blind, randomized clinical trial to assess the effectiveness of CoQ10 and Vitamin E supplements on periodontal health in patients with chronic periodontitis. A total of 120 patients from the Department of Periodontics at Boroujerd 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 received 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.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of, 1947833113
    • Amirhossein Farahmand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vitamin E; Participants in Group A were administered 400 mg of Vitamin E supplements on a daily basis throughout the two-month study period. After the study concluded, the clinical periodontal parameters were reevaluated to assess any potential impact of the supplements on oral health.. To compare the total antioxidant capacity in saliva before and after the consumption of the Vitamin E supplements, as well as in individuals who did not receive any form of medication, 2 ml of non-stimulated saliva was collected from each participant at the commencement and conclusion of the study. These samples were then analyzed using UV-spectrophotometric methods to determine any variations in antioxidant levels.	Drug: Receive 30 mg of Coq10; A total of 120 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.; Other Names: Receive 400 mg of Vitamin E; non Receive any medication
Experimental: Coq10; Participants in Group B were administered a daily dose of 30 mg of Coq10 supplements for two months. Following the study period, the clinical periodontal parameters were reevaluated to assess any potential impact of the supplements on oral health. To compare the total antioxidant capacity of saliva before and after the consumption of Coq10 supplements, as well as in individuals who did not receive any medication, 2 ml of non-stimulated saliva was collected from each participant at the commencement and conclusion of the study. The collected samples were then analyzed using UV-spectrophotometric methods to determine any variations in antioxidant levels.	Drug: Receive 30 mg of Coq10; A total of 120 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.; Other Names: Receive 400 mg of Vitamin E; non Receive any medication
Active Comparator: no-medication; Group C was not administered any medication during the study period lasting two months. Following this period, the clinical periodontal parameters were evaluated once again. Moreover, to analyze the total antioxidant capacity in saliva before and after the consumption of these supplements, as well as in individuals who were not given any medication, 2 ml of non-stimulated saliva was gathered from every participant at the commencement and conclusion of the study. This analysis was conducted using UV-spectrophotometric techniques.	Drug: Receive 30 mg of Coq10; A total of 120 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.; Other Names: Receive 400 mg of Vitamin E; non Receive any medication

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Islamic Azad University, Tehran

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2024
• Primary Completion (Actual): May 20, 2024
• Study Completion (Estimated): November 15, 2024

Study Registration Dates

• First Submitted: April 16, 2024
• First Submitted That Met QC Criteria: April 16, 2024
• First Posted (Actual): April 18, 2024

Study Record Updates

• Last Update Posted (Estimated): November 20, 2024
• Last Update Submitted That Met QC Criteria: November 17, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Periodontal disease, CoQ10, Vitamin E, antioxidant, saliva.
• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Chronic Disease; Disease Attributes; Periodontitis; Periodontal Diseases; Chronic Periodontitis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Micronutrients; Antioxidants; Protective Agents; Vitamins; Vitamin E
• Other Study ID Numbers: 346

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: find great satisfaction in the availability of individual participant data sets for sharing. These IPS serve as the foundation for published results and can be easily shared with others.
• IPD Sharing Time Frame: 3 Months
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No