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

NCT06695559 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-01-27

No results posted yet for this study

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.

Conditions

  • Periimplantitis
  • Periimplant Diseases

Interventions

OTHER

Labrida Bioclean

Debridement on the active comparator group will be implemented on the implant surface with Labrida Bioclean (i.e. the chitosan brush).

DRUG

Tetracycline slurry

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.

Sponsors & Collaborators

  • Aristotle University Of Thessaloniki

    lead OTHER

Principal Investigators

  • Lazaros Tsalikis · Professor

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-02-05
Primary Completion
2025-05-05
Completion
2025-05-05

Countries

  • Greece

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06695559 on ClinicalTrials.gov