Peri-Implantitis
Conditions
Keywords
laser, Er:YAG, Nd:YAG, periimplantitis, randomized controlled trial
Brief summary
A laser treatment for periimplantitis using two different wavelengths (Er:YAG and Nd:YAG) will be compared to standard treatment in a randomized clinical trial.
Detailed description
The general aim of this study is to evaluate the clinical outcome of the treatment of peri-implantitis using a combination of a Er:YAG and Nd:YAG laser protocol or using a conventional mechanical treatment in patients with a diagnosis of peri-implantitis.
Interventions
DEVICELightwalker Laser (Fotona)
For the laser group we will use a Lightwalker Laser (Fotona) with a Er:YAG 2940 nm and Nd:YAG 1064 nm wavelengths units. The laser protocol will follow the instructions of the manufacturer (TwinLight protocol) and consists of degranulation of necrotic soft tissue and bone, implant surface disinfection and creating spot bleeding in bone with Er:YAG and deep disinfection and biomodulation with Nd:YAG.
OTHERstandard
Granulation tissue elimination, mechanical instrumentation of the implant surface and curettage of intraosseous or supracrestally bone defects will be accomplished using plastic curets, under irrigation with sterile saline solution. Cotton pellets soaked in sterile saline solution will be use to clean debris and remains of removed tissue.
Sponsors
Luis Monteiro
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Clinical measurements will be performed by an evaluator unaware of group assignment.
Intervention model description
Two groups; laser and control
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* at least one implant with peri-implantitis * no serious mobility of the implants * written informed consent of the voluntary participant in the study * availability of participant for control visits for a follow-up of at least 12 months without interruptions
Exclusion criteria
* serious systematic disease * pregnancy * current use of photosensitive drugs, bisphosphonate medication or antibiotics * patients who do not want to follow post treatment recommendation of oral hygiene and follow-up visits
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants with treatment success | 6 months | Treatment success defined as implant survival with the absence of peri-implant probing depths (PD) greater than 5 mm with concomitant bleeding/suppuration and absence of progression of peri-implant bone loss. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bleeding on probing | 1 month | (BOP) evaluated as present if bleeding was evident within 30 s after probing, or absent, if no bleeding was noticed within 30 s after probing. |
| Probing depth | 1 month | measured from the mucosal margin to the bottom of the pocket. |
| Plaque index | 1 month | (PI) |
| Clinical attachment level gain | 1 month | Difference in clinical attachment level at baseline and follow up. |
| Quality of life questionnaire | 0 months | Oral Health Impact Profile-14 on the scale from 0 to 56 with higher scores indicating a poorer oral health-related quality of life. |
| Mucosal recession | 1 month | measured from the mucosal margin to the bottom of the pocket. |
Countries
Portugal
Contacts
Primary ContactLuis Monteiro, DMD, PhD
Outcome results
None listed