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This is a split-mouth randomized controlled clinical trial (RCT). After signing the informed consent, patients satisfying the inclusion criteria will undergo supragingival and subgingival professional oral hygiene of both arches performed with ultrasonic instrumentation with PEEK inserts, manual instrumentation with titanium curettes and air polishing with glycine powder.
After that, the following treatment will be randomly assigned:
The study will last 6 months. Patients will be visited at: T0, after 1 month from T0 (T1), after 3 months (T2), after 6 months (T3). Professional hygiene will be performed again at T2 and T3.
At each recall session, the following periodontal clinical indices were collected using a probe on each peri-implant site: BOP, GBI, conditions of the marginal mucosa (swelling and erythema), suppuration, migration of the marginal mucosa, PD, PI ,BS.
This is a split-mouth randomized controlled clinical trial (RCT). 30 patients is expected to be enrolled. After signing the informed consent, patients satisfying the inclusion criteria will undergo supragingival and subgingival professional oral hygiene of both arches performed with ultrasonic instrumentation with PEEK inserts, manual instrumentation with titanium curettes and air polishing with glycine powder.
After that, the following treatment will be randomly assigned:
The study will last 6 months. Patients will be visited at: T0, after 1 month from T0 (T1), after 3 months (T2), and after 6 months (T3). At T2 and T3, professional hygiene will be performed again.
At each recall session, the following periodontal clinical indices were collected using a probe on each peri-implant site:
BOP (bleeding on probing) and GBI (gingival bleeding index) Conditions of the marginal mucosa (swelling and erythema) Suppuration Migration of the marginal mucosa PD (probing depth) PI (plaque index) BS (bleeding score)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peri-implant mucositis sites | Experimental | Peri-implant mucositis sites will be randomly assigned to ozone treatment. |
|
| Contralateral peri-implant mucositis sites | Experimental | Contralateral peri-implant mucositis sites with respect to those treated with ozone will be assigned to chlorhexidine treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ozoral Pro and Ozoral gel administration | Other | Peri-implant mucositis sites will receive in-office Ozoral Pro administration after non-surgical therapy. Patients will use Ozoral Gel for the domiciliary administration once a day for 14 days after the visits (no rinsing and eating for 30 minutes after gel application). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Bleeding on Probing (BOP%) | Dichotomous scoring (yes/no) of bleeding sites | Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3) |
| Change in Gingival Bleeding Index (GBI%) | Quantitative assessment (percentage) of the bleeding sites (6 per tooth in total). Formula = n ° bleeding sites / n ° probed sites x100 | Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3) |
| Change in Suppuration (%) | Dichotomous scoring (yes/no) of suppurating sites | Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3) |
| Change in marginal mucosa condition | Scoring criteria: 0: normal mucosa
| Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3) |
| Change in mucosal margin | Dichotomous scoring (migrated/non migrated) | Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3) |
| Change in Probing Depth (PD) | Evaluation (in mm) of the depth of the gingival sulcus, through a millimeter periodontal probe; it is detected from the gingival margin to the bottom of the gingival sulcus or periodontal pocket, evaluated at 6 sites. | Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3) |
| Change in Plaque Index (PI% - O' Leary Index) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrea Scribante, DDS, PhD, MS | University of Pavia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia | Pavia | Lombardy | 27100 | Italy |
Data are available upon motivated request to the Authors.
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Split-mouth design
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Gels concealed
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| Curasept chlorhexidine gel 1% | Other | Peri-implant mucositis sites will receive in-office Curasept chlorhexidine gel 1% administration after non-surgical therapy. Patients will use chlorhexidine gel 1% for the domiciliary application once a day for 14 days after the visits (no rinsing and eating for 30 minutes after gel application). |
|
Evaluation of the presence of plaque on the 4 surfaces of teeth on the total amount of dental surfaces. Formula = n ° sites with plaque / total n ° of dental surfaces x100 |
| Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3) |
| Change in Bleeding Score (BS - Mombelli et al.) | Scoring criteria: 0: no bleeding
| Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3) |