Ozoral Pro and Ozoral Gel vs Chlorhexidine Gel 1% for the Management of Peri-implant Mucositis Sites.
- Conditions
- Peri-implant Mucositis
- Interventions
- Other: Ozoral Pro and Ozoral gel administrationOther: Curasept chlorhexidine gel 1%
- Registration Number
- NCT05254275
- Lead Sponsor
- University of Pavia
- Brief Summary
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.
- Detailed Description
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)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- age 18-70 years
- presence of 2 peri-implant mucositis sites per side (left and right) with PD > 5 mm
- no systemic, metabolic and autoimmune disease
- compliant patients
- neurologic, psychiatric and mental diseases
- patients taking bisphosphonates in the last 12 months
- patients taking antibiotics during the study
- pregnant and breastfeeding women
- patients undergoing anticancer treatment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Peri-implant mucositis sites Ozoral Pro and Ozoral gel administration Peri-implant mucositis sites will be randomly assigned to ozone treatment. Contralateral peri-implant mucositis sites Curasept chlorhexidine gel 1% Contralateral peri-implant mucositis sites with respect to those treated with ozone will be assigned to chlorhexidine treatment.
- Primary Outcome Measures
Name Time Method Change in Bleeding on Probing (BOP%) Baseline (T0), after 1 (T1), 3 (T2), 6 (T3), 9 (T4), 12 (T5), 15 (T6), 18 (T7), 21 (T8) and 24 months (T9) Dichotomous scoring (yes/no) of bleeding sites
Change in Plaque Index (PI% - O' Leary Index) Baseline (T0), after 1 (T1), 3 (T2), 6 (T3), 9 (T4), 12 (T5), 15 (T6), 18 (T7), 21 (T8) and 24 months (T9) 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 x100Change in Bleeding Score (BS - Mombelli et al.) Baseline (T0), after 1 (T1), 3 (T2), 6 (T3), 9 (T4), 12 (T5), 15 (T6), 18 (T7), 21 (T8) and 24 months (T9) Scoring criteria:
* 0: no bleeding
* 1: isolated visible spots
* 2: blood forms a confluent red line on the mucosal margin
* 3: profuse and copious bleedingChange in mucosal margin Baseline (T0), after 1 (T1), 3 (T2), 6 (T3), 9 (T4), 12 (T5), 15 (T6), 18 (T7), 21 (T8) and 24 months (T9) Dichotomous scoring (migrated/non migrated)
Change in Probing Depth (PD) Baseline (T0), after 1 (T1), 3 (T2), 6 (T3), 9 (T4), 12 (T5), 15 (T6), 18 (T7), 21 (T8) and 24 months (T9) 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.
Change in Gingival Bleeding Index (GBI%) Baseline (T0), after 1 (T1), 3 (T2), 6 (T3), 9 (T4), 12 (T5), 15 (T6), 18 (T7), 21 (T8) and 24 months (T9) Quantitative assessment (percentage) of the bleeding sites (6 per tooth in total).
Formula = n ° bleeding sites / n ° probed sites x100Change in Suppuration (%) Baseline (T0), after 1 (T1), 3 (T2), 6 (T3), 9 (T4), 12 (T5), 15 (T6), 18 (T7), 21 (T8) and 24 months (T9) Dichotomous scoring (yes/no) of suppurating sites
Change in marginal mucosa condition Baseline (T0), after 1 (T1), 3 (T2), 6 (T3), 9 (T4), 12 (T5), 15 (T6), 18 (T7), 21 (T8) and 24 months (T9) 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia
🇮🇹Pavia, Lombardy, Italy