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临床试验/NCT03656484
NCT03656484已完成2 期

Innovative Technology for Assessing the Periodontal Disease and New Periodontitis Treatment Based on Hyaluronic Acid and Melatonin

Concordia Dent Srl2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年1月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
50
试验地点
2
主要终点
Changes in Clinical attachment level (CAL)

研究概览

简要总结

The aim of the present study is to determine whether the association of Melatonin and Hyaluronic Acid to the antimicrobial TM paste (3% Tetracyclin and 3% Metronidazole) for periodontal maintenance therapy can improve the attachment level (AL) and alveolar bone support for moderate chronic periodontitis.

详细描述

Local drug delivery agents in periodontology has gained acceptance and popularity compared to systemic drugs due to decreased risk in development of resistant flora, opportunist infection, and side effects.

In order to improve the topical treatment for chronic periodontitis, Melatonin and Hyaluronic Acid have been added to antimicrobial topic paste commercially available.

  • A complex matrix composed of Tetracycline, Metronidazole, Melatonin and Hyaluronic Acid have been developed for local treatment of chronic periodontitis.
  • Microbiological, physical, chemical characterization of the newly obtained matrix and biocompatibility tests have been performed.
  • A randomized clinical trial will be perform on 50 patients with moderate chronic periodontitis recruited based on eligibility criteria and informed consent signed.
  • Mechanical debridement of the pockets by scaling and root planning will be performed prior to the adjunctive therapy.
  • Extensive clinical examination including charting the remaining teeth, clinical attachment level (CAL), presence of dental plaque (PI), gingival index (GI), calculus (CI), bleeding on probing (BOP), radiographic assessment and identification of periodontal pathogens with micro-IDent® test will be performed at the beginning of the study and 6 month after its completion.
  • Each patient will be randomized using sealed envelopes (according to a computer-generated randomization list) to one of the following topical administration (in the periodontal pocket of affected teeth), for 30 consecutive days: Tetracycline and Metronidazole paste (TM), n=25 patients and Tetracycline, Metronidazole, Melatonin, Hyaluronic Acid paste (TM-MHa), n=25 patients.
  • A statistical evaluation of data recorded during the entire follow-up period will be performed.

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
30 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • moderate chronic periodontitis, that is, > 2 interproximal sites with AL > 4 mm (not on the same tooth), or > 2 interproximal sites with pocket depth (PD) > 5 mm (not on the same tooth) (1),
  • at least 20 teeth present in the mouth,
  • no periodontal therapy during the last 6 months,
  • no antibiotic during the last 6 months,
  • good general health (no systemic condition affecting the course of periodontal disease, including malignancy), pregnancy,
  • no allergy to the product components,
  • good mental health.

排除标准

  • Patients not willing to sign consent form.
  • Patients not agreeing with the treatment protocol.

研究组 & 干预措施

Tetracycline-Metronidazole (TM) group

Active Comparator

Topical administration (in the periodontal pocket of affected teeth), for 30 consecutive days of 3%Tetracycline and 3%Metronidazole paste (TM), n=25 patients, considered control group.

干预措施: Tetracycline-Metronidazole (TM) group (Drug)

TM-Melatonin-Hyaluronic acid (TM-MHa) group

Experimental

Topical administration (in the periodontal pocket of affected teeth), for 30 consecutive days of 3% Tetracycline, 3% Metronidazole, 0.18% Melatonin and 3% Hyaluronic Acid (TM-MHa) paste, n=25 patients, considered experimental group.

干预措施: TM-Melatonin-Hyaluronic acid (TM-MHa) group (Drug)

结局指标

主要结局

Changes in Clinical attachment level (CAL)

时间窗: before treatment (Baseline), at 6 months post treatment completion

Changes CAL from Baseline (before treatment) at 6 months will be assessed using a standardised protocol.

次要结局

  • Treatment's influence on bactrial pathogens(before treatment (Baseline), at 6 months post treatment completion)
  • Changes in Alveolar bone height(before treatment (Baseline), at 6 months post treatment completion)

研究者

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

Corina Marilena Cristache

Senior Lecturer, DMD, PhD, Oral and Maxillofacial Surgeon, Project responsable

Carol Davila University of Medicine and Pharmacy

研究点 (2)

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