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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.

Status
Enrolling by invitation
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06373848
Enrollment
120
Registered
2024-04-18
Start date
2024-03-20
Completion date
2024-11-15
Last updated
2024-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periodontal Diseases

Keywords

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

Brief summary

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

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.

Interventions

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.

Sponsors

Islamic Azad University, Sanandaj
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

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.

Intervention model description

Parallel Assignment, Randomized, Double-blind, Controlled design.

Eligibility

Sex/Gender
ALL
Age
28 Years to 40 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Total Antioxidant capacity (TAC) of saliva3 monthsUV-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.

Secondary

MeasureTime frameDescription
Bleeding on probing3 monthsThe 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.

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026