search
Back to results

Effect of Hyaluronic Acid on Perimplantitis

Primary Purpose

Peri-Implantitis

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Hyaluronic Acid
Hydroxypropyl Guar
Sponsored by
Universidad de Granada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peri-Implantitis focused on measuring Peri-Implantitis, Dental Implants, Hyaluronic Acid, Clinical Trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Sham Comparator

    No Intervention

    Arm Label

    Test Group

    Control 1 Group

    Control 2 Group

    Arm Description

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

    Hydroxypropyl guar based gel, without any biological effect.

    No gel application, only standard perimplantitis treatment.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    May 15, 2017
    Last Updated
    May 16, 2017
    Sponsor
    Universidad de Granada
    Collaborators
    Ricerfarma S.r.l
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03157193
    Brief Title
    Effect of Hyaluronic Acid on Perimplantitis
    Official Title
    Effect of Hyaluronic Acid on Peri-implant Pathology: A Double-blind, Randomized, Controlled Clinical Trial.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2014 (Actual)
    Primary Completion Date
    January 2016 (Actual)
    Study Completion Date
    December 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidad de Granada
    Collaborators
    Ricerfarma S.r.l

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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 Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Peri-Implantitis
    Keywords
    Peri-Implantitis, Dental Implants, Hyaluronic Acid, Clinical Trial

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    61 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Test Group
    Arm Type
    Experimental
    Arm Description
    Hyaluronic acid gel 0.2% at baseline and later home applications by the patients during 45 days.
    Arm Title
    Control 1 Group
    Arm Type
    Sham Comparator
    Arm Description
    Hydroxypropyl guar based gel, without any biological effect.
    Arm Title
    Control 2 Group
    Arm Type
    No Intervention
    Arm Description
    No gel application, only standard perimplantitis treatment.
    Intervention Type
    Drug
    Intervention Name(s)
    Hyaluronic Acid
    Other Intervention Name(s)
    HA
    Intervention Description
    Hyaluronic acid gel application as coadjuvant in the treatment of perimplantitis.
    Intervention Type
    Drug
    Intervention Name(s)
    Hydroxypropyl Guar
    Other Intervention Name(s)
    Control 1
    Intervention Description
    Hydroxypropyl Guar gel application as sham comparator
    Primary Outcome Measure Information:
    Title
    Peri-implant probing depth
    Description
    Probing depth (mm) assessed by periodontal probe.
    Time Frame
    Baseline, change at 45 days and at 90 days.
    Title
    Peri-implant attachment level
    Description
    Probing attachment level (mm) calculated using probing depth and exposed implant threads.
    Time Frame
    Baseline, change at 45 days and at 90 days.
    Title
    Peri-implant bleeding
    Description
    Bleeding on probing expressed as % of bleeding implants in each group.
    Time Frame
    Baseline, change at 45 days and at 90 days.
    Title
    Marginal Bone level
    Description
    Alveolar bone level assesed in periapical digital radiographs by image processing software (ImageJ).
    Time Frame
    Baseline, change at 45 days and at 90 days.
    Title
    Peri-implant crevicular fluid cytokines.
    Description
    Inflammatory cytokines (IL1B and TNFa) measured in Peri-implant crevicular fluid by ELISA.
    Time Frame
    Baseline and change at 45 days.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    33634616
    Citation
    Sanchez-Fernandez E, Magan-Fernandez A, O'Valle F, Bravo M, Mesa F. Hyaluronic acid reduces inflammation and crevicular fluid IL-1beta concentrations in peri-implantitis: a randomized controlled clinical trial. J Periodontal Implant Sci. 2021 Feb;51(1):63-74. doi: 10.5051/jpis.1903660183.
    Results Reference
    derived

    Learn more about this trial

    Effect of Hyaluronic Acid on Perimplantitis

    We'll reach out to this number within 24 hrs