Effect of Hyaluronic Acid on Perimplantitis
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|ClinicalTrials.gov Identifier: NCT03157193|
Recruitment Status : Completed
First Posted : May 17, 2017
Last Update Posted : May 17, 2017
|Condition or disease||Intervention/treatment||Phase|
|Peri-Implantitis||Drug: Hyaluronic Acid Drug: Hydroxypropyl Guar||Phase 4|
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 (Clinical Trial)|
|Actual Enrollment :||61 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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|
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.
- Peri-implant probing depth [ Time Frame: Baseline, change at 45 days and at 90 days. ]Probing depth (mm) assessed by periodontal probe.
- 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.
- 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.
- 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).
- 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.