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

NCT06695559 | Completed Phase 4 DMC

• 1 other identifier: 200/16-06-2023
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

non-surgical treatment; periimplantitis; chitosan; tetracycline

Outcome Measures

Primary Outcomes (1)

• Probing Pocket Depth

  Pocket depth of periimplant sulcus measured in millimeters

  Change from baseline to 6 months

Secondary Outcomes (7)

• Radiographic bone fill

  Change from baseline to 6 months

• Clinical attachment level

  Change from baseline to 6 months

• Recession

  Change from baseline to 6 months

• Presence of plaque

  Change from baseline to 6 months

• Modified Bleeding Index

  Change from baseline to 6 months

Study Arms (2)

Labrida Bioclean

ACTIVE COMPARATOR

The implant pockets will be debrided with the Labrida BioClean™ biodegradable brush for 2 minutes and with the brush seated in an oscillating dental handpiece (NSK ESQ10 TEQ) and thereafter irrigated with sterile saline. The treatment will be repeated every three months. Debridement is performed with local anaesthesia as needed.

Other: Labrida Bioclean

Labrida Bioclean and tetracycline slurry

EXPERIMENTAL

The implant pockets will be debrided with the BioClean™ biodegradable brush for 2 minutes and with the brush seated in an oscillating dental handpiece (NSK ESQ10 TEQ) and thereafter irrigated two minutes with tetracycline-hydrochloride (Arco Interpharma AS, Hokksund, Norway) in sterile saline with a concentration of 150 mg/ml, as chemical detergent adjunct to the chitosan brush. The treatment will be repeated every three months. Debridement is performed with local anaesthesia as needed.

Drug: Tetracycline slurry

Interventions

Tetracycline slurry DRUG

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.

Also known as: Labrida Bioclean

Labrida Bioclean and tetracycline slurry

Labrida Bioclean OTHER

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

Labrida Bioclean

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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

You may not qualify if:

• 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.
• Mobile implant.
• Implants previously treated for peri-implantitis with grafting materials.
• Receiving medications known to induce mucosal hyperplasia.
• Uncontrolled diabetes (HbA1c \> 7).
• Pregnant or lactating.
• Any condition or current treatment for any condition, which in the opinion of the investigator and/or consulting physician, may constitute an unwarranted risk.
• Presence of psychological characteristics, such as inappropriate attitude or motivation, which will influence treatment execution and treatment outcome.
• Unwillingness to undergo treatment.
• If, in the medical opinion of the therapist, conditions are such that dental implants are deemed failing.
• Ongoing or previous radiotherapy to the head-neck region.
• Ongoing or previous chemotherapy.
• Systemic long-term corticosteroid treatment.
• Patients medicating with warfarin products or similar

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

Study Sites (1)

Aristotle University of Thessaloniki

Thessaloniki, 54124, Greece

Location

Related Publications (9)

• Koldsland OC, Scheie AA, Aass AM. Prevalence of peri-implantitis related to severity of the disease with different degrees of bone loss. J Periodontol. 2010 Feb;81(2):231-8. doi: 10.1902/jop.2009.090269.

  PMID: 20151801 BACKGROUND

• Costa FO, Takenaka-Martinez S, Cota LO, Ferreira SD, Silva GL, Costa JE. Peri-implant disease in subjects with and without preventive maintenance: a 5-year follow-up. J Clin Periodontol. 2012 Feb;39(2):173-81. doi: 10.1111/j.1600-051X.2011.01819.x. Epub 2011 Nov 23.

  PMID: 22111654 BACKGROUND

• Sorsa T, Ding Y, Salo T, Lauhio A, Teronen O, Ingman T, Ohtani H, Andoh N, Takeha S, Konttinen YT. Effects of tetracyclines on neutrophil, gingival, and salivary collagenases. A functional and western-blot assessment with special reference to their cellular sources in periodontal diseases. Ann N Y Acad Sci. 1994 Sep 6;732:112-31. doi: 10.1111/j.1749-6632.1994.tb24729.x.

  PMID: 7978785 BACKGROUND

• Mensi M, Scotti E, Calza S, Pilloni A, Grusovin MG, Mongardini C. A new multiple anti-infective non-surgical therapy in the treatment of peri-implantitis: a case series. Minerva Stomatol. 2017 Dec;66(6):255-266. doi: 10.23736/S0026-4970.17.04054-7. Epub 2017 Oct 3.

  PMID: 28975771 BACKGROUND

• Mombelli A, Feloutzis A, Bragger U, Lang NP. Treatment of peri-implantitis by local delivery of tetracycline. Clinical, microbiological and radiological results. Clin Oral Implants Res. 2001 Aug;12(4):287-94. doi: 10.1034/j.1600-0501.2001.012004287.x. English, French, German.

  PMID: 11488856 BACKGROUND

• Roos-Jansaker AM, Renvert H, Lindahl C, Renvert S. Submerged healing following surgical treatment of peri-implantitis: a case series. J Clin Periodontol. 2007 Aug;34(8):723-7. doi: 10.1111/j.1600-051X.2007.01098.x. Epub 2007 May 29.

  PMID: 17535286 BACKGROUND

• Samuelsson RS, Valnes AK, Wohlfahrt JC. Nonsurgical Treatment of Peri-implantitis Using a Chitosan Brush with Adjunctive Chemical Decontaminants- A Retrospective Case Series. Int J Oral Maxillofac Implants. 2022 Nov-Dec;37(6):1261-1267. doi: 10.11607/jomi.9602.

  PMID: 36450034 BACKGROUND

• Khan SN, Koldsland OC, Roos-Jansaker AM, Wohlfahrt JC, Verket A, Mdala I, Magnusson A, Salvesen E, Hjortsjo C. Non-surgical treatment of mild to moderate peri-implantitis using an oscillating chitosan brush or a titanium curette-A randomized multicentre controlled clinical trial. Clin Oral Implants Res. 2022 Dec;33(12):1254-1264. doi: 10.1111/clr.14007. Epub 2022 Oct 18.

  PMID: 36207993 BACKGROUND

• Wohlfahrt JC, Evensen BJ, Zeza B, Jansson H, Pilloni A, Roos-Jansaker AM, Di Tanna GL, Aass AM, Klepp M, Koldsland OC. A novel non-surgical method for mild peri-implantitis- a multicenter consecutive case series. Int J Implant Dent. 2017 Dec;3(1):38. doi: 10.1186/s40729-017-0098-y. Epub 2017 Aug 3.

  PMID: 28776288 BACKGROUND

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Lazaros Tsalikis

  Professor

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2024
• First Posted: November 19, 2024
• Study Start: February 5, 2024
• Primary Completion: May 5, 2025
• Study Completion: May 5, 2025
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)