At a glance
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Non Surgical Treatment of Peri-implantitis Using an Oscillating Chitosan Brush With Adjunctive Tetracycline Slurry: A Randomized Clinical Trial
In Brief
A Phase 4 clinical trial evaluating Labrida Bioclean and Tetracycline slurry for Periimplantitis and Periimplant Diseases. Completed, enrolled 40 participants across 1 site.
Detailed Summary
Aim: The aim of this prospective, randomized, parallel arm, blind clinical trial is to compare the clinical and radiographic outcomes following non-surgical treatment of mild peri-implant defects using Labrida Bioclean with or without the application of tetracycline slurry. Research Hypothesis: The hypothesis is that the adjunctive application of tetracycline slurry will enhance the clinical and radiographic results of non-surgical treatment of mild peri-implant defects (defined as peri-implant bone loss 3-6 mm with pocket depths 6 mm or deeper) with Labrida Bioclean. Probing pocket depth (PPD) reduction will be the primary outcome, whereas clinical attachment level (CAL), radiographic bone fill (RBF), recession depth (REC), modified bleeding index (mBI), presence of plaque (PL) , suppuration on probing (SUP) and Matrix Metalloproteinase-8 (MMP-8) levels on peri-implant sulcus fluid (PISF) will constitute the secondary outcome measures. Groups: Active comparator group: Debridement with Labrida Bioclean Experimental group: Debridement with Labrida Bioclean and irrigation with tetracycline slurry At the end of the treatment procedure patients will be given oral hygiene instructions and specifically patients of the experimental group will be instructed to refrain from oral hygiene for 24 hours before initiating oral hygiene. 1 month after therapy patients will be re-evaluated as a mean of PPD, CAL, REC, mBI, PL, SUP measurements and levels of MMP-8 on PISF. 3 months after therapy will be re-evaluated for second time as in the 1 month re-evaluation. Furthermore, treatment will be repeated as it was randomized on baseline. On 6 month re-evaluation PPD, CAL, REC, mBI, PL, SUP measurements will be made and also a periapical x-ray will be taken to compare the peri-implant bone level with the respective bone level on the x-ray of the baseline. On all of these appointments oral hygiene instructions and motivation will be given to the patients.
Study Details
Timeline
Interventions
Debridement on the active comparator group will be implemented on the implant surface with Labrida Bioclean (i.e. the chitosan brush).
On the experimental group debridement of the implant surface will be carried out with Labrida Bioclean and thereafter irrigation of the periimplant sulcus with tetracycline slurry will take place.