The Impact of Vitamin E and CoQ10 Supplements as an Adjunctive Non-surgical Periodontal Therapy on Chronic Periodontitis and Salivary Markers.
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Total Antioxidant capacity (TAC) of saliva
研究概览
简要总结
Non-surgical treatment of chronic periodontitis with vitamin E and coenzyme Q10 supplementation
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 28 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Receive 30 mg of Coq10 (Drug)
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.
干预措施: Receive 30 mg of Coq10 (Drug)
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.
干预措施: Receive 30 mg of Coq10 (Drug)
结局指标
主要结局
Total Antioxidant capacity (TAC) of saliva
时间窗: 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.
次要结局
- Bleeding on probing(3 months)
研究者
Amirhossein Farahmand
Periodontist, Associate Professor, Department of Periodontics, Faculty of Dentistry, Tehran Medical Sciences, Islamic Azad University, Tehran, Iran, Affiliation: Islamic Azad University, Tehran
Islamic Azad University, Tehran