Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Hyaluronic Acid on Perimplantitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03157193
Recruitment Status : Completed
First Posted : May 17, 2017
Last Update Posted : May 17, 2017
Sponsor:
Collaborator:
Ricerfarma S.r.l
Information provided by (Responsible Party):
Francisco Mesa, Universidad de Granada

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.

Condition or disease Intervention/treatment Phase
Peri-Implantitis Drug: Hyaluronic Acid Drug: Hydroxypropyl Guar Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Hyaluronic Acid on Peri-implant Pathology: A Double-blind, Randomized, Controlled Clinical Trial.
Actual Study Start Date : September 2014
Actual Primary Completion Date : January 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Test Group
Hyaluronic acid gel 0.2% at baseline and later home applications by the patients during 45 days.
Drug: Hyaluronic Acid
Hyaluronic acid gel application as coadjuvant in the treatment of perimplantitis.
Other Name: HA

Sham Comparator: Control 1 Group
Hydroxypropyl guar based gel, without any biological effect.
Drug: Hydroxypropyl Guar
Hydroxypropyl Guar gel application as sham comparator
Other Name: Control 1

No Intervention: Control 2 Group
No gel application, only standard perimplantitis treatment.



Primary Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Layout table for additonal information
Responsible Party: Francisco Mesa, Associate Professor in Periodontology, Universidad de Granada
ClinicalTrials.gov Identifier: NCT03157193    
Other Study ID Numbers: OTRI-3300
First Posted: May 17, 2017    Key Record Dates
Last Update Posted: May 17, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Francisco Mesa, Universidad de Granada:
Peri-Implantitis
Dental Implants
Hyaluronic Acid
Clinical Trial
Additional relevant MeSH terms:
Layout table for MeSH terms
Peri-Implantitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents