CompletedPhase 4

Non-surgical Treatment of Peri-implantitis Using Chitosan Brush and Tetracycline Slurry

Greece40 participantsStarted 2024-02-05

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Peri-implantitis defined as periimplant bone loss ≥ 3 mm on periapical x-rays distally, mesially or both and with Probing Pocket Depth (PPD) ≥6 mm. * Peri-implantitis as defined above on an implant that has been in function for more than 12 months prior to study start. * Above 18 years of age. * Eligible for treatment in an outpatient dental clinic (ie, American Society of Anesthesiologists classification I and II). * Had full-mouth plaque scores \< 20% prior to final inclusion. * Had at least one implant with a loading time of ≥ 12 months prior to baseline. * Signed Informed Consent obtained prior to start. * Psychological appropriateness * Consent to complete all follow-up visits. * Patients diagnosed with periodontal disease must have undergone causative treatment and be re-evaluated Exclusion Criteria: * Peri-implant bone loss \> 6 mm on periapical x-rays * Cemented supraconstructions and/or screw retained supraconstructions that for technical reasons makes it impossible to access implant for clinical measurements. * Technical complications which according to the examiners judgement has contributed to the disease state and not possible to resolve prior to final inclusion. * Mobile implant. * Implants previously treated for peri-implantitis with grafting materials. * Receiving medications known to induce mucosal hyperplasia. * Uncontrolled diabetes (HbA1c \> 7). * Receiving systemic antibiotics \< 3 months prior to inclusion. * Pregnant or lactatin…

What they're measuring

Probing Pocket Depth

Timeframe: Change from baseline to 6 months

Trial details

NCT IDNCT06695559

SponsorAristotle University Of Thessaloniki

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05-05