This is a randomized controlled clinical trial (RCT) with a split-mouth design. 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: * Ozoral Pro and Ozoral gel administration and home application for 2 peri-implant mucositis sites. * Curasept chlorhexidine gel 1% administration and domiciliary application for 14 days for 2 peri-implant contralateral sites. The study will last 2 years. Patients will be visited at: T0, after 1 month from T0 (T1), after 3 months (T2), after 6 months (T3), after 9 months (T4), after 12 months (T5), after 15 months (T6), after 18 months (T7), after 21 months (T8) and after 24 months (T9). For each time point, (except for T1), 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, GBI, conditions of the marginal mucosa (swelling and erythema), suppuration, migration of the marginal mucosa, PD, PI ,BS.
This is a randomized controlled clinical trial (RCT) with a split-mouth design, where a total of 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: * Ozoral Pro and Ozoral gel administration and home application for 2 peri-implant mucositis sites. * Curasept chlorhexidine gel 1% administration and domiciliary application for 14 days for 2 peri-implant contralateral sites. The study will last 2 years. Patients will be visited at: T0, after 1 month from T0 (T1), after 3 months (T2), after 6 months (T3), after 9 months (T4), after 12 months (T5), after 15 months (T6), after 18 months (T7), after 21 months (T8) and after 24 months (T9). For each time point, (except for T1), 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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
30
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).
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).
Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia
Pavia, Lombardy, Italy
Change in Bleeding on Probing (BOP%)
Dichotomous scoring (yes/no) of bleeding sites
Time frame: Baseline (T0), after 1 (T1), 3 (T2), 6 (T3), 9 (T4), 12 (T5), 15 (T6), 18 (T7), 21 (T8) and 24 months (T9)
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
Time frame: Baseline (T0), after 1 (T1), 3 (T2), 6 (T3), 9 (T4), 12 (T5), 15 (T6), 18 (T7), 21 (T8) and 24 months (T9)
Change in Suppuration (%)
Dichotomous scoring (yes/no) of suppurating sites
Time frame: Baseline (T0), after 1 (T1), 3 (T2), 6 (T3), 9 (T4), 12 (T5), 15 (T6), 18 (T7), 21 (T8) and 24 months (T9)
Change in marginal mucosa condition
Scoring criteria: * 0: normal mucosa * 1: minimal inflammation with color change and minor edema * 2: moderate inflammation with redness, edema and glazing * 3: severe inflammation with redness, edema, ulceration and spontaneous bleeding without probing
Time frame: Baseline (T0), after 1 (T1), 3 (T2), 6 (T3), 9 (T4), 12 (T5), 15 (T6), 18 (T7), 21 (T8) and 24 months (T9)
Change in mucosal margin
Dichotomous scoring (migrated/non migrated)
Time frame: Baseline (T0), after 1 (T1), 3 (T2), 6 (T3), 9 (T4), 12 (T5), 15 (T6), 18 (T7), 21 (T8) and 24 months (T9)
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.
Time frame: Baseline (T0), after 1 (T1), 3 (T2), 6 (T3), 9 (T4), 12 (T5), 15 (T6), 18 (T7), 21 (T8) and 24 months (T9)
Change in Plaque Index (PI% - O' Leary Index)
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
Time frame: Baseline (T0), after 1 (T1), 3 (T2), 6 (T3), 9 (T4), 12 (T5), 15 (T6), 18 (T7), 21 (T8) and 24 months (T9)
Change in Bleeding Score (BS - Mombelli et al.)
Scoring criteria: * 0: no bleeding * 1: isolated visible spots * 2: blood forms a confluent red line on the mucosal margin * 3: profuse and copious bleeding
Time frame: Baseline (T0), after 1 (T1), 3 (T2), 6 (T3), 9 (T4), 12 (T5), 15 (T6), 18 (T7), 21 (T8) and 24 months (T9)
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