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

NCT05254275 | Completed

• 1 other identifier: 2022-OZORAL2AA
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Peri-implant Mucositis

Keywords

peri-implant mucositis; ozone; supportive non-surgical therapy

Outcome Measures

Primary Outcomes (8)

• 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)

Study Arms (2)

Peri-implant mucositis sites

EXPERIMENTAL

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

Other: Ozoral Pro and Ozoral gel administration

Contralateral peri-implant mucositis sites

EXPERIMENTAL

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

Other: Curasept chlorhexidine gel 1%

Interventions

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).

Peri-implant mucositis sites

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).

Contralateral peri-implant mucositis sites

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pavia: lead

Study Sites (1)

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

Pavia, Lombardy, 27100, Italy

Location

Study Officials

• Andrea Scribante, DDS, PhD

  University of Pavia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Gels concealed.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Principal Investigator

Model Details: Split-mouth design

Study Record Dates

• First Submitted: February 14, 2022
• First Posted: February 24, 2022
• Study Start: March 22, 2022
• Primary Completion: June 15, 2024
• Study Completion: June 20, 2024
• Last Updated: July 8, 2024

Record last verified: 2024-07

Locations

IT (1)