T84.7
Conditions
Interventions
Group 1: Experimental group:
Removal of the suprastructure and replacement with a healing abutments for the duration of the study (6 months).
Afterwards, non-surgical peri-implantitis therapy / sub-ma
Sponsors
Medizinische Hochschule Hannover; Klinik für Zahnerhaltung, Parodontologie und Präventivzahnmedizin
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Informed consent to participate in the study Presence of at least one screw-type titanium implant exhibiting symptoms of peri-implantitis: Pocket probing depth (PPD): 6-9 mm, Radiographic bone loss (RBL): 3-6 mm, Bleeding and/or suppuration on probing (BOP/SOP) Presence of at least 2 mm of keratinized mucosa Implants loaded for at least 6 months with cemented or screw-fixed single crowns, crown blocks or bridges Two-part implant systems with screw-retained abutments / restoration platforms
Exclusion criteria
Exclusion criteria: Patients not willing to accept both types of treatment, in particular the removal of the suprastructure with possible destruction of the suprastructure and with possible additional costs arising from the manufacture of a removable prosthesis or splint Mobile implant Head- and neck-irradiated patients Patients undergoing chemotherapy or other therapies affecting the immune system (e.g. immunosuppressant, monoclonal antibodies) over the previous 5 years Patients treated or undergoing treatment with antiresorptive drugs (amino-bisphosphonates, denosumab) in high risk profile Uncontrolled diabetes (HbA1c > 7 %) Pregnancy and breast feeding period Antibiotic use within the previous 3 months Smoking more than 20 cigarettes per day or the equivalent Patients unable to attend the follow-up examination 6 months after the trial intervention Implants loaded with suprastructures using attachments for removable dentures (e.g. telescopic crowns, balls, locators, magnets)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Null hypothesis 1: Changes in pocket probing depth between the baseline examination and the follow-up examination 6 months after the trial intervention. Null hypothesis 2: Changes in the implant-associated microbiome between the baseline examination and the follow-up examination 6 months after the trial intervention. Null hypothesis 3: Changes in cytokine concentrations between the baseline examination and the follow-up examination 6 months after the trial intervention. | — |
Secondary
| Measure | Time frame |
|---|---|
| Null hypothesis 1: Changes in mucosal recession depth, clinical attachment level, bleeding / suppuration on probing and percentage radiographic bone loss between the baseline examination and the follow-up examination 6 months after the trial intervention. | — |
Countries
Germany
Contacts
Public ContactKnut Adam
Medizinische Hochschule Hannover; Klinik für Zahnerhaltung, Parodontologie und Präventivzahnmedizin
Outcome results
None listed