Effect of Hyaluronic Acid on Perimplantitis

Phase 4

Completed

• Conditions: Peri-Implantitis
• Interventions: Drug: Hydroxypropyl Guar; Drug: Hyaluronic Acid

• Registration Number: NCT03157193
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2014-09
• Primary Completion: 2016-01
• Study Completion: 2016-12
• Status Verified: 2017-05
• Study First Submitted: 2017-05-15
• Study First Submitted QC: 2017-05-16
• Last Update Submitted: 2017-05-16
• Study First Posted: 2017-05-17
• Last Update Posted: 2017-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control 1 Group	Hydroxypropyl Guar	Hydroxypropyl guar based gel, without any biological effect.
Test Group	Hyaluronic Acid	Hyaluronic acid gel 0.2% at baseline and later home applications by the patients during 45 days.

Primary Outcome Measures

Name	Time	Method
Peri-implant crevicular fluid cytokines.	Baseline and change at 45 days.	Inflammatory cytokines (IL1B and TNFa) measured in Peri-implant crevicular fluid by ELISA.
Peri-implant probing depth	Baseline, change at 45 days and at 90 days.	Probing depth (mm) assessed by periodontal probe.
Peri-implant attachment level	Baseline, change at 45 days and at 90 days.	Probing attachment level (mm) calculated using probing depth and exposed implant threads.
Peri-implant bleeding	Baseline, change at 45 days and at 90 days.	Bleeding on probing expressed as % of bleeding implants in each group.
Marginal Bone level	Baseline, change at 45 days and at 90 days.	Alveolar bone level assesed in periapical digital radiographs by image processing software (ImageJ).