Clinical trial NCT05256914: Ozonized In-office and Domiciliary Gels vs Chlorhexidine Gel 1% for the Management of Peri-implant Mucositis Sites
Official title: Ozonized In-office and Domiciliary Gels 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
Lead sponsor: University of Pavia
Sponsor class: OTHER
First posted: 2022-02-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Split-mouth design
Primary purpose: TREATMENT

Brief summary: 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:

* 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 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.

Detailed description: 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:

* 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 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)

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) and 6 months (T3)
measure: Change in Gingival Bleeding Index (GBI%)
timeFrame: Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3)
measure: Change in Suppuration (%)
timeFrame: Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3)
measure: Change in marginal mucosa condition
timeFrame: Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3)
measure: Change in mucosal margin
timeFrame: Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3)
measure: Change in Probing Depth (PD)
timeFrame: Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3)
measure: Change in Plaque Index (PI% - O' Leary Index)
timeFrame: Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3)
measure: Change in Bleeding Score (BS - Mombelli et al.)
timeFrame: Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3)
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, MS
role: PRINCIPAL_INVESTIGATOR
References: