Clinical trial NCT06373848: Non-surgical Treatment of Chronic Periodontitis With an Adjunctive Vitamin E and Coenzyme Q10 Supplementation
Official title: The Impact of Vitamin E and CoQ10 Supplements as an Adjunctive Non-surgical Periodontal Therapy on Chronic Periodontitis and Salivary Markers.
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Periodontal Diseases
Keywords: Periodontal disease, CoQ10, Vitamin E, antioxidant, saliva.
Lead sponsor: Islamic Azad University, Sanandaj
Sponsor class: OTHER
First posted: 2024-04-18
Enrollment: 120
Sex: ALL
Minimum age (years): 28
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment, Randomized, Double-blind, Controlled design.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Total Antioxidant capacity (TAC) of saliva
timeFrame: 3 months
Secondary outcomes:
measure: Bleeding on probing
timeFrame: 3 months
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Amirhossein Farahmand
Study officials:
References: