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Peri-implantitis is a plaque-associated condition occurring around dental implants, characterized by inflammation in the peri-implant mucosa and loss of supporting bone. To stop this progression, mechanical debridement of biofilm and calculus is commonly used to treat peri-implant lesions as well as the use of adjunctive measures such as titanium brushes. As observed, they improved plaque removal when compared with steel curettes alone. Therefore, it is of interest to evaluate the impact of this procedure in terms of clinical, radiographic and microbiological outcomes to assess their efficacy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Active Comparator | Participants will receive submucosal debridement alone |
|
| Test Group | Experimental | Participants will receive submucosal debridement and titanium brushes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Submucosal debridement | Device | Participants will undergo non-surgical submucosal debridement alone (SD) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pocket depth changes | The primary outcome variable will be pocket depth changes at 1 year of follow-up. | 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Full mouth plaque index (FMPI) | Assessed dichotomously as presence or absence of plaque will be scored if present along the gingival margin and if it can be removed with the side of the probe. The percentage of surfaces with plaque out of the total number of examined tooth surfaces will be calculated. | 12 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Javi Vilarrasa | Contact | +34 628553000 | jvilarrasa@uic.es | |
| Fares Al Hajeb | Contact | +34 696062892 | faresalhajeb@uic.es |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitat Internacional de Catalunya | Recruiting | Barcelona | Catalonia | 08195 | Spain |
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| ID | Term |
|---|---|
| D057873 | Peri-Implantitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| Submucosal debridement + titanium brushes | Device | Participants will undergo non-surgical submucosal debridement + titanium brushes (SD+TiBr) |
|
| Full mouth bleeding index (FMBI) |
Assessed dichotomously as presence or absence of bleeding after 30 seconds of gently probing. The proportion of bleeding surfaces out of the total number of examined surfaces will be calculated. |
| 12 Months |
| Modified plaque index (mPI) |
| 12 Months |
| Modified bleeding index (mBI) |
| 12 Months |
| Suppuration on probing (SoP) | Presence or absence of suppuration after gentle probing. | 12 Months |
| Mucosal recession (MR) | Distance (mm) from the mucosal margin and the interface between implant and abutment. | 12 Months |
| Keratinized mucosa (KM) | Distance (mm) from the mucosal margin to the mucogingival junction at the midbuccal aspect of the implant. | 12 Months |
| Radiographic parameters | Marginal bone level (MBL): distance (mm) between the implant shoulder and the base of the defect at the mesial and distal aspect. | 12 Months |
| Radiographic parameters | Intra-bony defect (ID): distance (mm) between the bottom of the defect and the line connecting the distal and mesial inter-proximal bone crest. | 12 Months |
| Radiographic parameters | Intra-bony defect width (WD): distance (mm) between the distal and mesial inter- proximal bone crest and the implant surface. | 12 Months |
| Radiographic parameters | Angulation of the intra-bony defect (AD): angle resulted from a vertical line along the outer implant surface and a line extending along the peri-implant bone defect. | 12 Months |
| Microbiological analysis | Total bacterial load (CFU/ml) Microbiome alpha-diversity | 12 Months |
| Microbiological analysis | Total bacterial load (CFU/ml) Microbiome beta-diversity | 12 Months |
| Microbiological analysis | Total bacterial load (CFU/ml) Relative and differential bacterial genera abundance at different timepoints | 12 Months |