Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
61 participants
INTERVENTIONAL
2014-09-30
2016-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Effect of Hyaluronic Acid Gel on Relieving Post-Implantation Pain
NCT05776290
Effectiveness of Hydroxyapatite Reinforced Chitosan Hydrogel in Modulation of Osseointegration
NCT06758440
Hyaluronic Acid Versus Red Injectable Platelet Rich Fibrin in Treatment of Periodontitis
NCT05768243
Effect of Hyaluronic Acid in the Treatment of Periodontal Pockets
NCT02170857
Effects of Polynucleotides and Hyaluronic Acid Based Subgingival Periodontal Pockets Re-instrumentation
NCT05210686
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Test Group
Hyaluronic acid gel 0.2% at baseline and later home applications by the patients during 45 days.
Hyaluronic Acid
Hyaluronic acid gel application as coadjuvant in the treatment of perimplantitis.
Control 1 Group
Hydroxypropyl guar based gel, without any biological effect.
Hydroxypropyl Guar
Hydroxypropyl Guar gel application as sham comparator
Control 2 Group
No gel application, only standard perimplantitis treatment.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Hyaluronic Acid
Hyaluronic acid gel application as coadjuvant in the treatment of perimplantitis.
Hydroxypropyl Guar
Hydroxypropyl Guar gel application as sham comparator
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Implants diagnosed with peri-implantitis according to the criteria of the Association of Dental Implantology.
Exclusion Criteria
* Pregnancy or breast-feeding.
* Neoplastic disease.
* Antibiotic treatment during the previous month.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ricerfarma S.r.l
OTHER
Universidad de Granada
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Francisco Mesa
Associate Professor in Periodontology
References
Explore related publications, articles, or registry entries linked to this study.
Sanchez-Fernandez E, Magan-Fernandez A, O'Valle F, Bravo M, Mesa F. Hyaluronic acid reduces inflammation and crevicular fluid IL-1beta concentrations in peri-implantitis: a randomized controlled clinical trial. J Periodontal Implant Sci. 2021 Feb;51(1):63-74. doi: 10.5051/jpis.1903660183.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
OTRI-3300
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.