Skip to main content
OpenTrials
Completed

NCT Number: NCT05254275

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Peri-implant Mucositis

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Pavia, Lombardy, 27100, Italy

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ozoral Pro and Ozoral gel administration

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).

Curasept chlorhexidine gel 1%

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).

Primary outcomes

  1. Change in Bleeding on Probing (BOP%)

    Time frame: Baseline (T0), after 1 (T1), 3 (T2), 6 (T3), 9 (T4), 12 (T5), 15 (T6), 18 (T7), 21 (T8) and 24 months (T9)

    Dichotomous scoring (yes/no) of bleeding sites

  2. Change in Gingival Bleeding Index (GBI%)

    Time frame: Baseline (T0), after 1 (T1), 3 (T2), 6 (T3), 9 (T4), 12 (T5), 15 (T6), 18 (T7), 21 (T8) and 24 months (T9)

    Quantitative assessment (percentage) of the bleeding sites (6 per tooth in total).

    Formula = n ° bleeding sites / n ° probed sites x100

  3. Change in Suppuration (%)

    Time frame: Baseline (T0), after 1 (T1), 3 (T2), 6 (T3), 9 (T4), 12 (T5), 15 (T6), 18 (T7), 21 (T8) and 24 months (T9)

    Dichotomous scoring (yes/no) of suppurating sites

  4. Change in marginal mucosa condition

    Time frame: Baseline (T0), after 1 (T1), 3 (T2), 6 (T3), 9 (T4), 12 (T5), 15 (T6), 18 (T7), 21 (T8) and 24 months (T9)

    Scoring criteria:

    • 0: normal mucosa
    • 1: minimal inflammation with color change and minor edema
    • 2: moderate inflammation with redness, edema and glazing
    • 3: severe inflammation with redness, edema, ulceration and spontaneous bleeding without probing

  5. Change in mucosal margin

    Time frame: Baseline (T0), after 1 (T1), 3 (T2), 6 (T3), 9 (T4), 12 (T5), 15 (T6), 18 (T7), 21 (T8) and 24 months (T9)

    Dichotomous scoring (migrated/non migrated)

  6. Change in Probing Depth (PD)

    Time frame: Baseline (T0), after 1 (T1), 3 (T2), 6 (T3), 9 (T4), 12 (T5), 15 (T6), 18 (T7), 21 (T8) and 24 months (T9)

    Evaluation (in mm) of the depth of the gingival sulcus, through a millimeter periodontal probe; it is detected from the gingival margin to the bottom of the gingival sulcus or periodontal pocket, evaluated at 6 sites.

  7. Change in Plaque Index (PI% - O' Leary Index)

    Time frame: Baseline (T0), after 1 (T1), 3 (T2), 6 (T3), 9 (T4), 12 (T5), 15 (T6), 18 (T7), 21 (T8) and 24 months (T9)

    Evaluation of the presence of plaque on the 4 surfaces of teeth on the total amount of dental surfaces.

    Formula = n ° sites with plaque / total n ° of dental surfaces x100

  8. Change in Bleeding Score (BS - Mombelli et al.)

    Time frame: Baseline (T0), after 1 (T1), 3 (T2), 6 (T3), 9 (T4), 12 (T5), 15 (T6), 18 (T7), 21 (T8) and 24 months (T9)

    Scoring criteria:

    • 0: no bleeding
    • 1: isolated visible spots
    • 2: blood forms a confluent red line on the mucosal margin
    • 3: profuse and copious bleeding

Sponsors and collaborators

Lead sponsor

University of Pavia

Other

Registry information

Official study title

Ozoral Pro and Ozoral Gel vs Chlorhexidine Gel 1% for the Management of Peri-implant Mucositis Sites: a Randomized Clinical Trial.

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Feb 24, 2022
Registry last updated
Jul 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.