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临床试验/NCT03157193
NCT03157193已完成4 期

Effect of Hyaluronic Acid on Peri-implant Pathology: A Double-blind, Randomized, Controlled Clinical Trial.

Universidad de Granada0 个研究点目标入组 61 人开始时间: 2014年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
61
主要终点
Peri-implant crevicular fluid cytokines.

研究概览

简要总结

The effect of the hyaluronic acid treatment on peri-implantitis has not been tested. The aim was to analyze the effect of a hyaluronic acid-containing gel on the clinical variables and the expression of biochemical inflammatory markers in the crevicular fluid of implants receiving perimplantitis treatment.

详细描述

The aim was to analyze the effect of a hyaluronic acid-containing gel on the clinical variables and the expression of biochemical inflammatory markers in the crevicular fluid of implants receiving perimplantitis treatment.

A randomized, controlled, double-blind clinical trial was designed on 100 perimplantitis affected implants placed in 61 subjects. Inclusion criteria were implants with at least 1 year of functional loading and with diagnosis of perimplantitis following the criteria from the Association of Dental Implantology. All implant received perimplantitis treatment. Each patient was randomly assigned to receive a gel containing 0.8% HA (Test group), a gel without HA (Placebo group) or no gel treatment (Control group). After a first gel application at baseline, test and placebo patients performed gel applications at home 3 times/day for 45 days. Clinical variables of each implant were recorded at baseline, 45 and 90 days (probing depth, attachment loss, bleeding). Intraoral radiographs of each implants were performed to measure marginal bone level. Peri-implant crevicular fluid was collected from each implant at baseline and after 45 days of treatment, to assess IL-1β and TNFα levels by ELISA technique. Clustering analysis, considering multiple implants within each patient, was 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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Implants with at least one year of functional load.
  • Implants diagnosed with peri-implantitis according to the criteria of the Association of Dental Implantology.

排除标准

  • Previous peri-implantitis treatment.
  • Pregnancy or breast-feeding.
  • Neoplastic disease.
  • Antibiotic treatment during the previous month.

研究组 & 干预措施

Control 1 Group

Sham Comparator

Hydroxypropyl guar based gel, without any biological effect.

干预措施: Hydroxypropyl Guar (Drug)

Test Group

Experimental

Hyaluronic acid gel 0.2% at baseline and later home applications by the patients during 45 days.

干预措施: Hyaluronic Acid (Drug)

结局指标

主要结局

Peri-implant crevicular fluid cytokines.

时间窗: Baseline and change at 45 days.

Inflammatory cytokines (IL1B and TNFa) measured in Peri-implant crevicular fluid by ELISA.

Peri-implant probing depth

时间窗: Baseline, change at 45 days and at 90 days.

Probing depth (mm) assessed by periodontal probe.

Peri-implant attachment level

时间窗: Baseline, change at 45 days and at 90 days.

Probing attachment level (mm) calculated using probing depth and exposed implant threads.

Peri-implant bleeding

时间窗: Baseline, change at 45 days and at 90 days.

Bleeding on probing expressed as % of bleeding implants in each group.

Marginal Bone level

时间窗: Baseline, change at 45 days and at 90 days.

Alveolar bone level assesed in periapical digital radiographs by image processing software (ImageJ).

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

Francisco Mesa

Associate Professor in Periodontology

Universidad de Granada

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