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

NCT06373848 | Enrolling By Invitation DMC

• 1 other identifier: 346
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Periodontal Diseases

Keywords

Periodontal disease, CoQ10, Vitamin E, antioxidant, saliva.

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Bleeding on probing

  3 months

Study Arms (3)

Vitamin E

EXPERIMENTAL

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

Coq10

EXPERIMENTAL

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

no-medication;

ACTIVE COMPARATOR

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

Interventions

Receive 30 mg of Coq10 DRUG

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.

Also known as: Receive 400 mg of Vitamin E, non Receive any medication

Coq10; Vitamin E; no-medication;

Eligibility Criteria

• Age: 28 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Islamic Azad University, Sanandaj: lead

Study Sites (1)

Amirhossein Farahmand

Tehran, 1947833113, Iran

Location

MeSH Terms

Conditions

Periodontal Diseases

Interventions

coenzyme Q10; Vitamin E

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study was carried out utilizing a double-blind approach. In order to guarantee objectivity, all three groups - the Vitamin E group, the Coq10 group, and the control group - received medications that were indistinguishable in terms of appearance, packaging, and color. Additionally, to minimize any potential bias, a clinician who had no association with the research labeled the medications as A, B, and C (empty) based on their content, and then distributed them among the patients.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Periodontist, Associate Professor, Department of Periodontics, Faculty of Dentistry, Tehran Medical Sciences, Islamic Azad University, Tehran, Iran, Affiliation: Islamic Azad University, Tehran

Model Details: Parallel Assignment, Randomized, Double-blind, Controlled design.

Study Record Dates

• First Submitted: April 16, 2024
• First Posted: April 18, 2024
• Study Start: March 20, 2024
• Primary Completion: May 20, 2024
• Study Completion: November 15, 2024
• Last Updated: November 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 3 Months

Locations

IR (1)