Clinical Trial: Effect of Hyaluronic Acid on Perimplantitis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: Universidad de Granada

Current Primary Outcome:

  • Peri-implant probing depth [ Time Frame: Baseline, change at 45 days and at 90 days. ]
    Probing depth (mm) assessed by periodontal probe.
  • Peri-implant attachment level [ Time Frame: Baseline, change at 45 days and at 90 days. ]
    Probing attachment level (mm) calculated using probing depth and exposed implant threads.
  • Peri-implant bleeding [ Time Frame: Baseline, change at 45 days and at 90 days. ]
    Bleeding on probing expressed as % of bleeding implants in each group.
  • Marginal Bone level [ Time Frame: Baseline, change at 45 days and at 90 days. ]
    Alveolar bone level assesed in periapical digital radiographs by image processing software (ImageJ).
  • Peri-implant crevicular fluid cytokines. [ Time Frame: Baseline and change at 45 days. ]
    Inflammatory cytokines (IL1B and TNFa) measured in Peri-implant crevicular fluid by ELISA.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Universidad de Granada

Dates:
Date Received: May 15, 2017
Date Started: September 2014
Date Completion:
Last Updated: May 16, 2017
Last Verified: May 2017