Peri-Implantitis
Conditions
Interventions
The objective of this study is to evaluate the efficacy of dual-wavelength photobiomodulation (PBMT), with or without autogenous or xenogeneic connective tissue grafts, in the treatment of peri-implan
the second consists of treating peri-implant disease with the use of free gingival grafts of autogenous or xenogeneic origin
the third consists of treating peri-implant disease with PBMT combined with the free gingival graft technique. Ninety patients will be randomized according to inclusion criteria and allocated to six g
Control – peri-implant treatment only
Study 2: EGL – peri-implant treatment using autogenous free gingival graft
CMX – peri-implant treatment with free gingival graft with xenogeneic collagen matrix
Study 3: PMBT-EGL – peri-implant treatment with autogenous free gingival graft combined with PBMT
PMBT-CMX – peri-implant treatment with CMX gingival graft combined with PBMT
Sponsors
Universidade Federal de Uberlândia
Universidade Federal de Uberlândia
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients with at least one implant diagnosed with peri-implantitis; The implant must present: radiographic bone loss > 2mm; probing depth > 5mm; bleeding and/or suppuration on probing; prosthesis with at least 6 months of function; absence of implant mobility; age =18 years
Exclusion criteria
Exclusion criteria: Patients with previous peri-implant treatment at the surgical site; ASA III patients (except diabetics); Heavy smokers (>20 cigarettes/day); Uncontrolled diabetic patients (HbA1c > 7% or fasting glucose > 180 mg/dL); Use of antibiotics in the last 30 days; Use of medications that alter the inflammatory response or bone metabolism; Pregnant and breastfeeding women; Patients with hemoglobinopathies; Patients with other systemic alterations that may compromise healing
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The probing depth, to be evaluated by clinical analysis, will be the primary outcome of this project. It is expected that PBMT and the use of autogenous/xenogenous soft tissue grafts will reduce the probing depth by more than 1 mm compared to the treatment of peri-implantitis without PBMT and without the use of gingival grafts. | — |
Secondary
| Measure | Time frame |
|---|---|
| The clinical attachment level and the peri-implant mucosal margin level will be evaluated by clinical analysis. It is expected that PBMT and the use of autogenous/xenogenous soft tissue grafts will maintain the clinical attachment level and prevent an increase in the peri-implant margin level of more than 0.5 mm compared to the treatment of peri-implantitis without PBMT and without the use of gingival grafts;The height and thickness of the keratinized mucosa around the implants will be evaluated by clinical analysis. It is expected that PBMT and the use of autogenous/xenogenous soft tissue grafts will increase the height by 1 mm and the thickness of the keratinized mucosa around the implants by 0.5 mm compared to the treatment of peri-implantitis without PBMT and without the use of gingival grafts;The pain and discomfort experienced by patients in the postoperative period will be assessed using the VAS scale. It is expected that PBMT and the use of xenogeneic soft tissue grafts will reduce the level of pain and discomfort by two points on the VAS scale compared to peri-implantitis treatment without PBMT and without the use of gingival grafts, or with the use of autogenous gingival grafts;The peri-implant bone level will be assessed by radiographic analysis. PBMT and the use of autogenous and xenogeneic soft tissue grafts are expected to reduce peri-implant bone loss by more than 1 mm compared to peri-implantitis treatment without PBMT and without the use of gingival grafts;Biofilm accumulation and peri-implant mucosal inflammation will be evaluated by dichotomous clinical analysis. It is expected that PBMT and the use of autogenous and xenogeneic soft tissue grafts will reduce biofilm and inflammation around implants by 5% compared to peri-implantitis treatment without PBMT and without gingival grafting | — |
Countries
Brazil
Contacts
Public ContactGuilherme Oliveira
Universidade Federal de Uberlândia
Outcome results
None listed