Ozoral Pro and Ozoral Gel vs Chlorhexidine Gel 1% for the Management of Peri-implant Mucositis Sites.

University of Pavia

Status: Completed

Conditions: Peri-implant Mucositis

Treatments: Other: Curasept chlorhexidine gel 1%; Other: Ozoral Pro and Ozoral gel administration

Study type: Interventional

Funder types: Other

Identifiers

NCT05254275

2022-OZORAL2AA

Details and patient eligibility

About

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.

Full 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)

Enrollment: 30 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups

Peri-implant mucositis sites

Experimental group

Description:

Peri-implant mucositis sites will be randomly assigned to ozone treatment.

Treatment:

Other: Ozoral Pro and Ozoral gel administration

Contralateral peri-implant mucositis sites

Experimental group

Description:

Contralateral peri-implant mucositis sites with respect to those treated with ozone will be assigned to chlorhexidine treatment.

Treatment:

Other: Curasept chlorhexidine gel 1%