Effect of Hyaluronic Acid on Perimplantitis

Peri-Implantitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03157193
• Other study ID #: OTRI-3300
• Status: Completed
• Phase: Phase 4
• First received: May 15, 2017
• Last updated: May 16, 2017
• Start date: September 2014
• Est. completion date: December 2016

Study information

• Verified date: May 2017
• Source: Universidad de Granada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: December 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Peri-Implantitis

Intervention

Drug:
• Hyaluronic Acid
Hyaluronic acid gel application as coadjuvant in the treatment of perimplantitis.
• Hydroxypropyl Guar
Hydroxypropyl Guar gel application as sham comparator

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Universidad de Granada	Ricerfarma S.r.l

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peri-implant probing depth	Probing depth (mm) assessed by periodontal probe.	Baseline, change at 45 days and at 90 days.
Primary	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.
Primary	Peri-implant bleeding	Bleeding on probing expressed as % of bleeding implants in each group.	Baseline, change at 45 days and at 90 days.
Primary	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.
Primary	Peri-implant crevicular fluid cytokines.	Inflammatory cytokines (IL1B and TNFa) measured in Peri-implant crevicular fluid by ELISA.	Baseline and change at 45 days.