Effect of Hyaluronic Acid on Perimplantitis

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Peri-Implantitis

Intervention / Treatment
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* Drug: Hyaluronic Acid
* Drug: Hydroxypropyl Guar


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test Group<br>Hyaluronic acid gel 0.2% at baseline and later home applications by the patients during 45 days. | Drug: Hyaluronic Acid<br>* Hyaluronic acid gel application as coadjuvant in the treatment of perimplantitis.<br>* Other names: HA;|
| Sham Comparator: Control 1 Group<br>Hydroxypropyl guar based gel, without any biological effect. | Drug: Hydroxypropyl Guar<br>* Hydroxypropyl Guar gel application as sham comparator<br>* Other names: Control 1;|
| No Intervention: Control 2 Group<br>No gel application, only standard perimplantitis treatment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peri-implant probing depth | Probing depth (mm) assessed by periodontal probe. | Baseline, change at 45 days and at 90 days. | 
| Peri-implant attachment level | Probing attachment level (mm) calculated using probing depth and exposed implant threads. | Baseline, change at 45 days and at 90 days. | 
| Peri-implant bleeding | Bleeding on probing expressed as % of bleeding implants in each group. | Baseline, change at 45 days and at 90 days. | 
| Marginal Bone level | 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. | Inflammatory cytokines (IL1B and TNFa) measured in Peri-implant crevicular fluid by ELISA. | Baseline and change at 45 days. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peri-Implantitis, Dental Implants, Hyaluronic Acid, Clinical Trial