Clinical trial NCT05254275: Ozoral Pro and Ozoral Gel vs Chlorhexidine Gel 1% for the Management of Peri-implant Mucositis Sites.
Official title: Ozoral Pro and Ozoral Gel vs Chlorhexidine Gel 1% for the Management of Peri-implant Mucositis Sites: a Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peri-implant Mucositis
Keywords: peri-implant mucositis
ozone
supportive non-surgical therapy
Lead sponsor: University of Pavia
Sponsor class: OTHER
First posted: 2022-02-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Split-mouth design
Primary purpose: TREATMENT

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)

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in Bleeding on Probing (BOP%)
timeFrame: Baseline (T0), after 1 (T1), 3 (T2), 6 (T3), 9 (T4), 12 (T5), 15 (T6), 18 (T7), 21 (T8) and 24 months (T9)
measure: Change in Gingival Bleeding Index (GBI%)
timeFrame: Baseline (T0), after 1 (T1), 3 (T2), 6 (T3), 9 (T4), 12 (T5), 15 (T6), 18 (T7), 21 (T8) and 24 months (T9)
measure: Change in Suppuration (%)
timeFrame: Baseline (T0), after 1 (T1), 3 (T2), 6 (T3), 9 (T4), 12 (T5), 15 (T6), 18 (T7), 21 (T8) and 24 months (T9)
measure: Change in marginal mucosa condition
timeFrame: Baseline (T0), after 1 (T1), 3 (T2), 6 (T3), 9 (T4), 12 (T5), 15 (T6), 18 (T7), 21 (T8) and 24 months (T9)
measure: Change in mucosal margin
timeFrame: Baseline (T0), after 1 (T1), 3 (T2), 6 (T3), 9 (T4), 12 (T5), 15 (T6), 18 (T7), 21 (T8) and 24 months (T9)
measure: Change in Probing Depth (PD)
timeFrame: Baseline (T0), after 1 (T1), 3 (T2), 6 (T3), 9 (T4), 12 (T5), 15 (T6), 18 (T7), 21 (T8) and 24 months (T9)
measure: Change in Plaque Index (PI% - O' Leary Index)
timeFrame: Baseline (T0), after 1 (T1), 3 (T2), 6 (T3), 9 (T4), 12 (T5), 15 (T6), 18 (T7), 21 (T8) and 24 months (T9)
measure: Change in Bleeding Score (BS - Mombelli et al.)
timeFrame: Baseline (T0), after 1 (T1), 3 (T2), 6 (T3), 9 (T4), 12 (T5), 15 (T6), 18 (T7), 21 (T8) and 24 months (T9)
Secondary outcomes:
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia
state: Lombardy
Study officials:
affiliation: University of Pavia
name: Andrea Scribante, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References: