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Enrolling by Invitation

NCT Number: NCT06373848

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

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

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Key information

Age range

28 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Amirhossein Farahmand

Tehran, 1947833113, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Receive 400 mg of Vitamin E, non Receive any medication

Primary outcomes

  1. Total Antioxidant capacity (TAC) of saliva

    Time frame: 3 months

    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.

Secondary outcomes

  1. Bleeding on probing

    Time frame: 3 months

    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.

Sponsors and collaborators

Lead sponsor

Islamic Azad University, Sanandaj

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 18, 2024
Registry last updated
Nov 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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