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Completed

NCT Number: NCT03157193

Effect of Hyaluronic Acid on Perimplantitis

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.

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Key information

Conditions

Peri-implantitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Hyaluronic acid

Drug

Hyaluronic acid gel application as coadjuvant in the treatment of perimplantitis.

Other names: HA

Hydroxypropyl Guar

Drug

Hydroxypropyl Guar gel application as sham comparator

Other names: Control 1

Primary outcomes

  1. Peri-implant probing depth

    Time frame: Baseline, change at 45 days and at 90 days.

    Probing depth (mm) assessed by periodontal probe.

  2. 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.

  3. 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.

  4. 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).

  5. 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.

Sponsors and collaborators

Lead sponsor

Universidad de Granada

Other

Collaborators

  • Ricerfarma S.r.l

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
May 17, 2017
Registry last updated
May 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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