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

Peri-implant Mucositis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05254275
• Other study ID #: 2022-OZORAL2AA
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 22, 2022
• Est. completion date: May 27, 2024

Study information

• Verified date: June 2023
• Source: University of Pavia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: May 27, 2024
• Est. primary completion date: May 24, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Mucositis
• Peri-implant Mucositis

Intervention

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).
• 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).

Locations

Country	Name	City	State
Italy	Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia	Pavia	Lombardy

Sponsors (1)

Lead Sponsor	Collaborator
University of Pavia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)