Peri-Implantitis
Conditions
Brief summary
34 patients diagnosed with mild to moderate peri-implantitis, defined as 2-4 mm peri-implant bone loss, will be randomized to either test treatment with Labrida BioClean® or control treatment with titanium curettes. In total 40 subjects (20 % drop-out rate), treated by 5 clinicians at 5 centers will be included in the study.
Detailed description
4.1 Study design The study will be a prospective multicentre randomized, examiner blinded controlled clinical trial of 24 months duration. Change in mucosal inflammation will be reported after 6 months while the true endpoint parameters i.e., peri-implant attachment will be reported after 1 and 2 years. 4.2 Treatment allocation and blinding Patients will be allocated either to test (Labrida BioClean® or control (titanium curettes) treatment by computer-generated block randomization to ensure equal sample sizes. The examiners will be blinded to the treatment allocation. 4.3 Study setting In total six centres will be included. Patient screening, inclusions and all clinical examinations will be performed by a board-certified specialist in periodontology, registered dental hygienist or specialist in prosthetics at each centre. Treatments will be performed by a dental hygienist or a board-certified specialist in periodontology. 4.4 Patients 40 patients (20+20) diagnosed with mild to moderate peri-implantitis, defined as peri-implant bone loss 2 -4 mm, will be included in the study. 4.5 Recruitment of patients Patients referred to or seeking care in the included clinics will be screened for inclusion.
Interventions
DEVICELabrida BioClean
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 with sterile saline or commercially available and area-specific titanium curettes (Langer and Langer, Rønvig) for 2 minutes and thereafter irrigated with sterile saline. The treatment will be repeated every three months until the terminal examination after 24 months. Debridement is performed with local anaesthesia as needed. Healthy sites will not be retreated.
OTHERTitanium curettes
Peri-implant pockets will be debrided using titanium curettes.
Sponsors
Labrida AS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Examiners blinded to treatment allocation since treatment is performed by a dental hygienist.
Intervention model description
Patients will be allocated either to test (Labrida BioClean® or control (titanium curettes) treatment by computer-generated block randomization to ensure equal sample sizes. The examiners will be blinded to the treatment allocation.
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Peri-implantitis defined as 2-4 mm bone loss distally, mesially or both, Probing Pocket Depth (PPD) ≥4mm and inflammation as demonstrated by Bleeding on Probing (mBoP) at least score 2. In addition to the above mentioned main inclusion criteria, patients can be included if they meet the following conditions: 1. Peri-implantitis as defined above on an implant that has been in function for more than 12 months prior to study start. 2. Above 18 years of age. 3. Eligible for treatment in an outpatient dental clinic (ie, ASA I and II). 4. Had full-mouth plaque scores ≤20% prior to final inclusion and no visual plaque at the included implants prior to study start. 5. Had at least one implant with a loading time of ≥ 12 months prior to baseline. 6. Signed Informed Consent obtained prior to start. 7. Psychological appropriateness. 8. Consent to complete all follow-up visits.
Exclusion criteria
Peri-implant bone loss \> 4 mm, radiotherapy, chemotherapy, systemic long-term corticosteroid treatment, pregnancy or nursing, anatomical abnormalities, prosthetic factors making access to clinical measurements impossible. In addition to the above mentioned main
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inflammation | 3 months after first treatment | Reduction in peri-implant mucositis as measured clinically up to three months after therapy. |
| Progression of bone loss | 12 months after first treatment. | True end-point |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Morbidity | 3 months | To compare patient morbidity after use of Labrida BioClean® versus titanium curettes determined on a VAS scale assessed at the 3 month treatment visit. |
| Adverse events | 12 months | To assess safety of BioClean™ by evaluating the occurrence of adverse events. |
Countries
Norway, Sweden
Outcome results
None listed