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

NCT ID: NCT05254275

Last Updated: 2024-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-22
• Study Completion Date: 2024-06-20

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)

Conditions

Peri-implant Mucositis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Peri-implant mucositis sites

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

Group Type: EXPERIMENTAL

Ozoral Pro and Ozoral gel administration

Intervention Type: OTHER

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).

Contralateral peri-implant mucositis sites

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

Group Type: EXPERIMENTAL

Curasept chlorhexidine gel 1%

Intervention Type: OTHER

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).

Interventions

Ozoral Pro and Ozoral gel administration

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).

Intervention Type: OTHER

Curasept chlorhexidine gel 1%

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).

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pavia

OTHER

Sponsor Role: lead

Responsible Party

Andrea Scribante

Associate Professor, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrea Scribante, DDS, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pavia

Locations

Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia

Pavia, Lombardy, Italy

Countries

Italy

Other Identifiers

2022-OZORAL2AA

Identifier Type: -

Identifier Source: org_study_id