Peri-Implantitis and Peri-implant Mucositis
Conditions
Keywords
electrolytic cleaning, reconstructive treatment, demineralized bovine bone mineral (DBBM), titanium brush
Brief summary
Implants diagnosed with peri-implantitis and amenable for bone reconstructive treatment will be enrolled in the study. The implants will randomly be treated with either an electrolytic or a mechanical cleaning of the implant surface (with titanium brushes). In all cases, a bone graft will be used to rebuild missing bone.
Detailed description
Implants diagnosed with peri-implantitis and amenable for bone reconstructive treatment will be enrolled in the study. All implants will receive reconstructive therapy by means of a collagenated bone graft, however the method of decontamination will be randomized between electrolytic cleaning or titanium rotating brushes. In both cases, titanium curettes will be used to remove hard deposits on the implant surface and degranulation will be completed with curettes.
Interventions
PROCEDUREtest device GalvoSurge
Electrolytic decontamination
PROCEDUREMechanical decontamination with titanium brush
Reconstructive treatment of peri-implantitis after removal of hard and soft tissue deposits from the implant surface followed by mechanical decontamination with titanium brush
Sponsors
George Eastman Dental Hospital, Italy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Implants with peri-implantitis (defined according to 2017 World Workshop definitions) * contained defects with infra osseous component amenable to reconstructive treatment * fixed and removable superstructures * patients with no systemic conditions affecting healing (uncontrolled diabetes mellitus, chronic corticosteroid use, autoimmune conditions affecting connective tissue) * smoking more than 10 cigarettes
Exclusion criteria
* mobile implants * non removable crowns (both cement or screw retained) that cannot be removed prior to surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Probing pocket depth | from baseline to 12, 24 months post-surgery | distance (mm) between marginal mucosa and bottom of probable pocket |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in recession | baseline to 12 and 24 months post-op | change between baseline and 24 months (mm) |
| change in CAL | between baseline and 24 months | change in CAL between baseline and 24 months (mm) |
| Suppuration on probing (SoP) | baseline, 12, 24 months | Dichotomic variable |
| Bleeding on probing | baseline, 12, 24 months | Dichotomic variable (yes/ no) |
| Keratinized mucosa (KM) | baseline, 12, 24 months | continuous, measured in mm, from the margin of the mucosa to the mucogingival junction |
| Treatment Success | 24 months | Composite outcome comprising implant not lost, no more than 1 mm of buccal recession, no more than 5 mm of PPD, no SOP, no more than 1 bleeding spot on probing, no loss of crestal bone (mm) |
Contacts
CONTACTLucrezia Paterno Holtzman, DDS, MS
CONTACTLuca Cordaro, DDS MD
Outcome results
None listed