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Effect of Enamel Matrix Derivative or Hyaluronic Acid on Non-Surgical Treatment of Peri-Implantitis
Sponsor: Gazi University
Summary
The aim of the present randomized controlled clinical study is to compare the clinical, radiographic, and patient-centered efficacy of adjunctive application of either enamel matrix derivative (EMD) or hyaluronic acid (HA) gel in conjunction with non-surgical therapy compared to non-surgical therapy alone following a 12-month healing period. Therefore, the following question related to the study is raised: • Does the adjunctive local application of EMD or HA to non-surgical submucosal mechanical treatment of peri-implantitis result in better clinical, radiographic, and patient-centered outcomes compared to non-surgical therapy alone? A total of 60 patients referred to the Gazi University Department of Periodontology, will be randomly assigned to receive the local application of EMD or HA in combination with non-surgical submucosal mechanical treatment of peri-implantitis or non-surgical therapy alone. Clinical measurements will be recorded at baseline, 3, 6, and 12 months after surgeries. Patient oral health related to the treatment procedures using a written questionnaire \[Oral Health Impact Profile (OHIP-14)\] and post-treatment pain and overall patient satisfaction about treatment modalities responses will be evaluated prior to treatment and 3, 6, and 12 months following therapy.
Official title: Adjunctive Local Application of Enamel Matrix Derivative or Hyaluronic Acid to Non-surgical Mechanical Treatment of Peri-implantitis: a 12-month Randomized Controlled Clinical Trial
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2024-11-01
Completion Date
2026-01-30
Last Updated
2024-10-01
Healthy Volunteers
Yes
Conditions
Interventions
Enamel Matrix Derivative application
After submarginal instrumentation (i.e., titanium curettes plus oscillating chitosan brush), implant surfaces will be conditioned for 2 min with 24% ethylene-diaminetetraacetate EDTA (PrefGel®, Institut Straumann AG). Then, the sites will be completely rinsed with saline solution and thoroughly dried with air. Repeated irrigation and air-drying will be done in the area until complete bleeding control with sterile gauzes. Then EMD (Emdogain®, Institut Straumann AG) will be gently applied with a blunt-tipped sterile syringe until overflowing from the mucosal margin.
Hyaluronic Acid (HA)
After submarginal instrumentation of the implant surface (i.e., titanium curettes plus oscillating chitosan brush), the cross-linked hyaluronic acid gel composed of a mixture of cross-linked (1.6%) and natural (0.2%) will be will be implemented to the peri-implant pockets.
Control
Implants allocated to the control group will be treated with the same sub-marginal instrumentation (i.e., titanium curettes plus oscillating chitosan brush). Implant surface will be irrigated with with sterile saline.