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

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

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.

Study Overview

• Status: Completed
• Conditions: Peri-implant Mucositis
• Intervention / Treatment: Other: Ozoral Pro and Ozoral gel administration; Other: Curasept chlorhexidine gel 1%

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)

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Lombardy
    • Pavia, Lombardy, Italy, 27100
      • Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Peri-implant mucositis sites; Peri-implant mucositis sites will be randomly assigned to ozone treatment.	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).
Experimental: Contralateral peri-implant mucositis sites; Contralateral peri-implant mucositis sites with respect to those treated with ozone will be assigned to chlorhexidine treatment.	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Bleeding on Probing (BOP%)	Dichotomous scoring (yes/no) of bleeding sites	Baseline (T0), after 1 (T1), 3 (T2), 6 (T3), 9 (T4), 12 (T5), 15 (T6), 18 (T7), 21 (T8) and 24 months (T9)
Change in Gingival Bleeding Index (GBI%)	Quantitative assessment (percentage) of the bleeding sites (6 per tooth in total). Formula = n ° bleeding sites / n ° probed sites x100	Baseline (T0), after 1 (T1), 3 (T2), 6 (T3), 9 (T4), 12 (T5), 15 (T6), 18 (T7), 21 (T8) and 24 months (T9)
Change in Suppuration (%)	Dichotomous scoring (yes/no) of suppurating sites	Baseline (T0), after 1 (T1), 3 (T2), 6 (T3), 9 (T4), 12 (T5), 15 (T6), 18 (T7), 21 (T8) and 24 months (T9)
Change in marginal mucosa condition	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	Baseline (T0), after 1 (T1), 3 (T2), 6 (T3), 9 (T4), 12 (T5), 15 (T6), 18 (T7), 21 (T8) and 24 months (T9)
Change in mucosal margin	Dichotomous scoring (migrated/non migrated)	Baseline (T0), after 1 (T1), 3 (T2), 6 (T3), 9 (T4), 12 (T5), 15 (T6), 18 (T7), 21 (T8) and 24 months (T9)
Change in Probing Depth (PD)	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.	Baseline (T0), after 1 (T1), 3 (T2), 6 (T3), 9 (T4), 12 (T5), 15 (T6), 18 (T7), 21 (T8) and 24 months (T9)
Change in Plaque Index (PI% - O' Leary Index)	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	Baseline (T0), after 1 (T1), 3 (T2), 6 (T3), 9 (T4), 12 (T5), 15 (T6), 18 (T7), 21 (T8) and 24 months (T9)
Change in Bleeding Score (BS - Mombelli et al.)	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	Baseline (T0), after 1 (T1), 3 (T2), 6 (T3), 9 (T4), 12 (T5), 15 (T6), 18 (T7), 21 (T8) and 24 months (T9)

Collaborators and Investigators

• Sponsor: University of Pavia
• Investigators: Principal Investigator: Andrea Scribante, DDS, PhD, University of Pavia

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2022
• Primary Completion (Actual): June 15, 2024
• Study Completion (Actual): June 20, 2024

Study Registration Dates

• First Submitted: February 14, 2022
• First Submitted That Met QC Criteria: February 14, 2022
• First Posted (Actual): February 24, 2022

Study Record Updates

• Last Update Posted (Actual): July 8, 2024
• Last Update Submitted That Met QC Criteria: July 5, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: ozone; peri-implant mucositis; supportive non-surgical therapy
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Stomatognathic Diseases; Mouth Diseases; Mucositis; Anti-Infective Agents, Local; Anti-Infective Agents; Disinfectants; Chlorhexidine
• Other Study ID Numbers: 2022-OZORAL2AA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No