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临床试验/NCT03964935
NCT03964935Unknown2 期

The Effect of Lycopene Antioxidant Gel Compared to Minocycline Hydrochloride Microspheres as Adjunctive to Non Surgical Periodontal Treatment by Measuring Matrix Metalloproteinase-9, Transforming Growth Factor-Beta 1, Interleukin-8, and Tissue Inhibitor of Metalloproteinases -1

University of Baghdad1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年12月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
入组人数
30
试验地点
1
主要终点
Measuring level of inflammatory markers MMP-9, TGF-Beta 1, IL-8, TIMP-1 in the gingival crevicular fluid

研究概览

简要总结

Periodontal diseases are among the most common medical conditions that may influence humans; 50% of the adult population can be affected by this illness. The condition is usually initiated by lack or reduction in oral hygiene which is then aggravated by the presence of microorganisms within biofilm which will induce a sequel of events that will lead to periodontitis. Scaling, root planning, and polishing (SRP) are the golden standard procedures in the treatment. Systemic antibiotics as adjunctive therapy has been established to be an excellent modality in controlling the bacterial virulence, hence, supporting the conventional SRP therapy. in order to avoid and limit the harmful effect of systemic antibiotics different locally applied preparations have been introduced including antioxidants. The aim of this prospective clinical study is to compare between the effect of Minocycline hydrochloride (HCL) microsphere and Lycopene gel when they are applied intrapocket subgingival with conventional SRP therapy

详细描述

Periodontal diseases are among the most common medical conditions that may influence humans; 50% of the adult population can be affected by this illness. The condition is usually initiated by lack or reduction in oral hygiene which is then aggravated by the presence of microorganisms within biofilm which will induce a sequel of events that will lead to periodontitis. The multifactorial nature of the disease necessitates a multifactorial approach to restore the balance within the oral echo system. Scaling, root planning, and polishing (SRP) are the golden standard procedures in the treatment; the therapeutic nature of these clinical intervention is based on disrupting the biofilm and stimulate the host defense mechanism to have the upper hand in targeting the microorganisms and their toxins. Systemic antibiotics as adjunctive therapy has been established to be an excellent modality in controlling the bacterial virulence, hence, supporting the conventional SRP therapy; in order to avoid and limit the harmful effect of systemic antibiotics different locally applied preparations have been introduced. Clinical parameters bleeding on probing (BOP), pocket depth (PD), and clinical attachment level (CAL) have been improved when Minocycline hydrochloride (HCL) microspheres was locally applied as an adjunctive drug to conventional SRP. Oxidative stress is another factor related to periodontitis. The free radicals are a by-product of the inflammatory reaction induced by the disease progression; free radicals eliminated by antioxidants which is naturally found in the diet especially fruits and vegetables; however, when the imbalance occur and the free radicals over weighed the antioxidants there will be further initiation of the destruction mechanism. The role of antioxidant as therapeutic agent in reducing the oxidative stress has been well studied and their supporting effect to the conventional SRP treatment is well documented. Lycopene extract can be applied as a gel intrapocket subgingival and it can have a promising result with the SRP.

The aim of this prospective clinical study is to compare between the effect of Minocycline HCL microsphere and Lycopene gel when they are applied intrapocket subgingival with conventional SRP therapy. The study will utilize split mouth technique; three sites within the oral cavity that have a pocket depth greater than 5 mm will be included. Each site will be designated to receive a specific treatment, Control group (site) will have SRP and water irrigation treatment, active group (site) will have local application of Minocycline HCL gel following SRP therapy, and the experimental site which will receive lycopene and SRP treatment. The influence of these therapeutic agents will be determined by the expression of selected inflammation-related markers in the gingival crevicular fluid collected from the experimental sites. The markers that will be examined are MMP-9, interleukin (IL)-8, TGF-Beta 1, and TIMP1. The change in the clinical parameters will be measured before the commencement of treatment and it will be examined later to observe the effect of each locally applied drug when compared to the control group (SRP plus water irrigation).

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
Single (Participant)

入排标准

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

入选标准

  • Patients with chronic periodontitis with CAL ≥ 5 mm.
  • No history of any systemic condition.
  • Patient able to follow the required instructions.
  • Willing to sign an informed consent form.
  • Didn't receive any antibiotic therapy and periodontal therapy in the last 2-3 months.

排除标准

  • Patients with systemic diseases that influence the condition (ex, hypertension, diabetes, kidney diseases and transplants).
  • Patients who refuse to write an informed consent form.
  • Taking certain medications including antibiotics, antihypertensive, anticonvulsants, immunosuppressants, or any other drug that may affect the periodontal health status.
  • Pregnant and lactating women.

研究组 & 干预措施

Lycopene

Experimental

Prepared by solving lycopene powder in a solvent (ethanol: propylene glycol: water in the ratio of 50:30:20). The solution was then gelled by adding 8% hydroxypropyl cellulose (HPC). The concentration of the prepared gel equals to 2%.

After scaling, root planing, and polishing (SRP), the gel delivered into periodontal pocket using insulin syringes, the therapeutic dose is about 2mg/0.1 ml.

干预措施: Lycopene (Drug)

Minocycline HCL

Active Comparator

Minocycline HCL Microspheres, 1mg minocycline powder per cartridge. A locally applied antibiotic that is placed directly into the infected periodontal pocket following SCR.

干预措施: Minocycline HCl 1mg Oral Powder (Drug)

Distilled water

Placebo Comparator

Used to irrigate periodontal pockets after SRP

干预措施: Distilled water (Other)

结局指标

主要结局

Measuring level of inflammatory markers MMP-9, TGF-Beta 1, IL-8, TIMP-1 in the gingival crevicular fluid

时间窗: 14 days

Level of selected inflammatory markers (MMP-9, TGF-Beta 1, IL-8, TIMP-1) is measured in the gingival crevicular fluid before and after use of different interventions

Measuring clinical attachment level

时间窗: 14 days

Clinical attachment level (CAL) is measured at baseline and after using different interventions

Measuring bleeding on probing

时间窗: 14 day

Measuring bleeding on probing (BOP), indicated by score 0 (no bleeding) score 1 (bleeding), from periodontal pockets treated with different interventions at baseline and at the end of the trial period.

次要结局

未报告次要终点

研究者

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

Ali A Abdulkareem

Lecturer

University of Baghdad

研究点 (1)

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