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临床试验/NCT02315222
NCT02315222Unknown2 期

Impact of Dietary Supplements on Oral and Periodontal Wound Healing

University of Milan6 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2014年11月最近更新:
适应症
干预措施

试验速览

阶段
2 期
入组人数
60
试验地点
6
主要终点
Clinical Attachment Level (CAL)

研究概览

简要总结

Patient with periodontal disease undergoing full mouth disinfection will be given dietary supplements or placebo and reevaluated after 3 months.

详细描述

Introduction The beneficial effect of vitamins and dietary supplements on oral wound healing has been recently reported in clinical trials (for review see Van der Valden, JCP 2011). In periodontal tissue, the imbalanced ratio between virulence of pathogens bacteria and proportionate host response induce a destructive process of periodontal ligament, cementum and alveolar bone. The importance of micronutrients including vitamins, calcium and antioxidant for periodontal health was reported in several clinical studies and the integration between traditional (non surgical and surgical interventions) and micronutritional approaches were proposed for treatment of periodontitis (Van der Velden et al. 2011).

Clinical trials reported that daily supplement of fruit, vegetable and berry juice powder, vitamin D, Calcium seems to improve periodontal health in patients with chronic periodontitis that were treated with non-surgical or surgical periodontal therapy or were in maintenance program (Chapple et al 2012, Garcia et al 2011, Miley et al 2009, Bashutski et al. 2011). However, the beneficial effects of micronutrients on periodontal health and healing need to be more deeply investigated. Furthermore, a dietary supplement specifically formulated for periodontal health needs to be tested.

Regenium is a dietary supplement with Q-TER (coenzyme q10 terclatrate), DHA Omega 3, Boswellia serrata, Vitamins and mineral salts that was formulated to improve the collagen formation and the maintenance of the health of oral mucosa. Q-TER plays a key role in the ATP synthesis and energetic metabolism, and has a strong antioxidant function. A recent study also reported the function of Q-10 as inhibitor of osteoclast differentiation (Moon et al. 2012). DHA Omega 3 (Resolvine) has an important antioxidant function, affecting the cellular aging and moderates the anti-inflammatory mechanisms. Boswellia serrata showed beneficial effects on wound healing and contraction (Mallik et al. 2010). This micronutrient reduces the synthesis of leukotrienes in intact neutrophils by inhibiting 5-lipoxygenase, the key enzyme involved in the biosynthesis of leukotrienes and in the inflammatory process.

The aim of the present study is to evaluate if patients affected by severe periodontal disease and treated with periodontal non-surgical therapy benefit from dietary supplements (Regenium). It will be assessed the effect of Regenium on clinical parameters of periodontal wound healing and on systemic inflammation related to periodontal disease.

  1. Experimental procedure

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)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • severe periodontal disease: at least 2 sites with Probing Pocket Depth (PPD)>7mm, Bleeding On Probing (BOP)> 25%
  • Age between 18 and 65 years
  • Signed informed consent

排除标准

  • Systemic diseases that may affect periodontal status
  • Metabolic disorders
  • Nutritional conditions that may alter the formation and maturation of connective tissue
  • Pregnancy or lactation

研究组 & 干预措施

Test

Active Comparator

Dietary Supplementation

干预措施: Regenium (Dietary Supplement)

Test

Active Comparator

Dietary Supplementation

干预措施: Full Mouth Disinfection (Procedure)

Control

Placebo Comparator

Placebo Supplementation

干预措施: Placebo (Dietary Supplement)

Control

Placebo Comparator

Placebo Supplementation

干预措施: Full Mouth Disinfection (Procedure)

结局指标

主要结局

Clinical Attachment Level (CAL)

时间窗: 3 months

Periodontal Pocket Depth (PPD)

时间窗: 3 months

次要结局

  • Full Mouth Bleeding Score (FMBS)(3 months)
  • Tooth mobility(3 months)
  • Full Mouth Plaque Score (FMPS)(3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Giulio Rasperini

Professor

University of Milan

研究点 (6)

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