Status:
COMPLETED
Treatment of Mild to Moderate Peri-implantitis Using an Oscillating Chitosan Device
Lead Sponsor:
Labrida AS
Conditions:
Peri-Implantitis
Eligibility:
All Genders
19+ years
Phase:
NA
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 tit...
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 month...
Eligibility Criteria
Inclusion
- 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:
- 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, ASA I and II).
- Had full-mouth plaque scores ≤20% prior to final inclusion and no visual plaque at the included implants prior to study start.
- 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.
Exclusion
- 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 exclusion criteria, patients should be excluded if they meet any of the following conditions:
- 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.
- Patients diagnosed with periodontal disease must have undergone causative treatment and be re-evaluated.
- Implants previously treated for peri-implantitis with grafting materials.
- Receiving medications known to induce mucosal hyperplasia.
- Uncontrolled diabetes HbA1c \> 52, equals 7.0.
- Receiving systemic antibiotics \< 3 months prior to inclusion.
- 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.
- Advanced, untreated and uncontrolled peri-implantitis on neighbouring implants.
- If, in the 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 warfarine products or similar.
- \-
Key Trial Info
Start Date :
August 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2020
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT03373448
Start Date
August 1 2017
End Date
December 1 2020
Last Update
October 24 2022
Active Locations (5)
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1
Spesdent
Oslo, Norway, 0352
2
Colosseum Majorstuen
Oslo, Norway, 0369
3
Bjerke Tannmedisin AS
Oslo, Norway, 0589
4
Odontologiska Institutionen
Jönköping, Sweden, 55111