Effect of Hyaluronic Acid on Perimplantitis

May 16, 2017 updated by: Francisco Mesa, Universidad de Granada

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

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.

Study Overview

Status

Completed

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Control 1
No Intervention: Control 2 Group
No gel application, only standard perimplantitis treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peri-implant probing depth
Time Frame: Baseline, change at 45 days and at 90 days.
Probing depth (mm) assessed by periodontal probe.
Baseline, change at 45 days and at 90 days.
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.
Baseline, change at 45 days and at 90 days.
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.
Baseline, change at 45 days and at 90 days.
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).
Baseline, change at 45 days and at 90 days.
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.
Baseline and change at 45 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Granada

Collaborators

Ricerfarma S.r.l

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2014

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

May 15, 2017

First Submitted That Met QC Criteria

May 16, 2017

First Posted (Actual)

May 17, 2017

Study Record Updates

Last Update Posted (Actual)

May 17, 2017

Last Update Submitted That Met QC Criteria

May 16, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OTRI-3300

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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