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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laser | Experimental | For the laser group we will use a Lightwalker Laser (Fotona) with a Er:YAG 2940 nm and Nd:YAG 1064 nm wavelengths units. |
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| Control | Active Comparator | Standard periimplantitis treatment will be conducted in the control group. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lightwalker Laser (Fotona) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with treatment success | 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Plaque index | (PI) | 1 month |
| Plaque index | (PI) | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luis Monteiro, DMD, PhD | Contact | +351 919120226 | luis.monteiro@iucs.cespu.pt |
| Name | Affiliation | Role |
|---|---|---|
| Luis Monteiro, DMD, PhD | Instituto Universitário de Ciências da Saude, CESPU | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Universitário de Ciências da Saude, CESPU | Recruiting | Porto | 4585-116 | Portugal |
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| ID | Term |
|---|---|
| D057873 | Peri-Implantitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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Two groups; laser and control
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Clinical measurements will be performed by an evaluator unaware of group assignment.
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| standard | Other | 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. |
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| Plaque index |
(PI) |
| 6 months |
| Plaque index | (PI) | 12 months |
| Bleeding on probing | (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. | 1 month |
| Bleeding on probing | evaluated as present if bleeding was evident within 30 s after probing, or absent, if no bleeding was noticed within 30 s after probing. | 3 months |
| Bleeding on probing | evaluated as present if bleeding was evident within 30 s after probing, or absent, if no bleeding was noticed within 30 s after probing. | 6 months |
| Bleeding on probing | evaluated as present if bleeding was evident within 30 s after probing, or absent, if no bleeding was noticed within 30 s after probing. | 12 months |
| Probing depth | measured from the mucosal margin to the bottom of the pocket. | 1 month |
| Probing depth | measured from the mucosal margin to the bottom of the pocket. | 3 months |
| Probing depth | measured from the mucosal margin to the bottom of the pocket. | 6 months |
| Probing depth | measured from the mucosal margin to the bottom of the pocket. | 12 months |
| Mucosal recession | measured from the mucosal margin to the bottom of the pocket. | 1 month |
| Mucosal recession | measured from the mucosal margin to the bottom of the pocket. | 3 months |
| Mucosal recession | measured from the mucosal margin to the bottom of the pocket. | 6 months |
| Mucosal recession | measured from the mucosal margin to the bottom of the pocket. | 12 months |
| Clinical attachment level gain | Difference in clinical attachment level at baseline and follow up. | 1 month |
| Clinical attachment level gain | Difference in clinical attachment level at baseline and follow up. | 3 months |
| Clinical attachment level gain | Difference in clinical attachment level at baseline and follow up. | 6 months |
| Clinical attachment level gain | Difference in clinical attachment level at baseline and follow up. | 12 months |
| Quality of life questionnaire | Oral Health Impact Profile-14 on the scale from 0 to 56 with higher scores indicating a poorer oral health-related quality of life. | 0 months |
| Quality of life questionnaire | Oral Health Impact Profile-14 on the scale from 0 to 56 with higher scores indicating a poorer oral health-related quality of life. | 1 month |
| Quality of life questionnaire | Oral Health Impact Profile-14 on the scale from 0 to 56 with higher scores indicating a poorer oral health-related quality of life. | 3 months |
| Quality of life questionnaire | Oral Health Impact Profile-14 on the scale from 0 to 56 with higher scores indicating a poorer oral health-related quality of life. | 6 months |
| Quality of life questionnaire | Oral Health Impact Profile-14 on the scale from 0 to 56 with higher scores indicating a poorer oral health-related quality of life. | 12 months |