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

NCT05254275 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-07-08

No results posted yet for this study

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.

Conditions

  • Peri-implant Mucositis

Interventions

OTHER

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).

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).

Sponsors & Collaborators

  • University of Pavia

    lead OTHER

Principal Investigators

  • Andrea Scribante, DDS, PhD · University of Pavia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-22
Primary Completion
2024-06-15
Completion
2024-06-20

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05254275 on ClinicalTrials.gov