In-office and Domiciliary Use of a New Ozonized Gel for the Management of Periodontal Disease
Primary Purpose
Periodontal Diseases
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Chlorhexidine
Ozoral gels
Sponsored by
About this trial
This is an interventional treatment trial for Periodontal Diseases focused on measuring ozone, chlorhexidine, split-mouth
Eligibility Criteria
Inclusion Criteria:
- Presence of bilateral periodontal sites according to the new Classification of Periodontal and Peri-implant Diseases (Severity: Staging I; Complexity: Staging II).
- No systemic disease;
- Compliant patients.
Exclusion Criteria:
- Absence of dental implants;
- Neurological and psychiatric diseases;
- Patients taking bisphosphonates during the previous 12 months from the beginning of the study;
- Pregnant and/or breastfeeding women;
- Patients undergoing anticancer therapy.
- Patients with poor compliance.
Sites / Locations
- Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Split-mouth Group A
Split-mouth Group B
Arm Description
Half of patients will be assigned to this group. Quadrants Q1/Q4 will receive ozone administration. Quadrants Q2/Q3 will receive chlorhexidine administration.
Half of patients will be assigned to this group Quadrants Q2/Q3 will receive ozone administration. Quadrants Q1/Q4 will receive chlorhexidine administration.
Outcomes
Primary Outcome Measures
Change in R - Gingival recession
Distance (in mm) between the gingival margin and the amelo-cemental junction.
Change in PPD - Probing Pocket Depth
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.
Change in Bleeding on Probing (BOP%)
Dichotomous scoring (yes/no) of bleeding sites
Change in Plaque Control Record (PCR%)
% assessment of the amount of plaque on dental surfaces; it is detected on 4 surfaces: distal, mesial, vestibular, lingual / palatal. The number of sites with plaque is divided by the total number of sites available in the mouth and multiplied by 100. Results indicate the index as a percentage.
Change in Dental mobility (Miller, 1985)
Scoring criteria
Grade 0: oscillation within 0.2 mm; the teeth move naturally and there are no mobility problems;
Grade I: horizontal mobility of the tooth from 0.2 to 1 mm;
Grade II: horizontal mobility of the tooth from 1 to 2 mm;
Grado III: horizontal mobility equal to or greater than 3 mm or vertical mobility of the tooth.
Secondary Outcome Measures
Full Information
NCT ID
NCT05254288
First Posted
February 14, 2022
Last Updated
October 19, 2022
Sponsor
University of Pavia
1. Study Identification
Unique Protocol Identification Number
NCT05254288
Brief Title
In-office and Domiciliary Use of a New Ozonized Gel for the Management of Periodontal Disease
Official Title
Evaluation of a New In-office and Domiciliary Ozonized Gel for the Management of Periodontal Disease
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
March 22, 2022 (Actual)
Primary Completion Date
October 15, 2022 (Actual)
Study Completion Date
October 19, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pavia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to evaluate the efficacy of non-surgical periodontal therapy with supportive home oral care for the treatment of periodontal disease.
Patients with bilateral periodontal pathological sites will undergo professional dental hygiene with ultrasonic handpiece (Piezon EMS with PerioSlim inserts) followed by manual instrumentation with Gracey curettes and application of erythritol Airflow powders. Then, patients will be randomly divided into two groups according to a split-mouth design: the Control Group will undergo a split-mouth application of chlorhexidine gel 1% for quadrants 1/3 (or 2/4), while for the Trial Group Ozoral Pro for quadrants 2/4 (or 1/3) will be used. Patients will use the products at home with one daily application for the following 14 days after the visits. The Trial Group will use Ozoral Gel for home applications.
The following indexes will be assessed at baseline, T1 (1 month), T2 (3 months) and T3 (6 months): recession, PPD, BoP %, CAL, PCR %. Contextually, the application of the two gels will be performed.
Detailed Description
The aim of this study is to evaluate the efficacy of non-surgical periodontal therapy with supportive home oral care for the treatment of periodontal disease comparing chlorhexidine and ozone gels.
Patients with bilateral periodontal pathological sites will undergo professional dental hygiene with ultrasonic handpiece (Piezon EMS with PerioSlim inserts) followed by manual instrumentation with Gracey curettes and application of erythritol Airflow powders. Then, patients will be randomly divided into two groups according to a split-mouth design:
Control Group: application of chlorhexidine gel 1% for quadrants 1/3 (or 2/4)
Trial Group: administration of Ozoral Pro for quadrants 2/4 (or 1/3).
Patients will use the products at home with one daily application for the following 14 days after the visits. The Trial Group will use Ozoral Gel for home applications.
The following indexes will be assessed at baseline, T1 (1 month), T2 (3 months) and T3 (6 months): recession, PPD, BoP %, CAL, PCR %. Contextually, the application of the two gels will be performed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Diseases
Keywords
ozone, chlorhexidine, split-mouth
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Split-mouth
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Gels concealed
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Split-mouth Group A
Arm Type
Experimental
Arm Description
Half of patients will be assigned to this group. Quadrants Q1/Q4 will receive ozone administration. Quadrants Q2/Q3 will receive chlorhexidine administration.
Arm Title
Split-mouth Group B
Arm Type
Experimental
Arm Description
Half of patients will be assigned to this group Quadrants Q2/Q3 will receive ozone administration. Quadrants Q1/Q4 will receive chlorhexidine administration.
Intervention Type
Other
Intervention Name(s)
Chlorhexidine
Intervention Description
In-office and domiciliary use of chlorhexidine for 14 days.
Intervention Type
Other
Intervention Name(s)
Ozoral gels
Intervention Description
In-office administration of Ozoral Pro and domiciliary use of Ozoral gel for 14 days.
Primary Outcome Measure Information:
Title
Change in R - Gingival recession
Description
Distance (in mm) between the gingival margin and the amelo-cemental junction.
Time Frame
Time Frame: baseline, 1, 3 and 6 months after baseline
Title
Change in PPD - Probing Pocket Depth
Description
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.
Time Frame
Time Frame: baseline, 1, 3 and 6 months after baseline
Title
Change in Bleeding on Probing (BOP%)
Description
Dichotomous scoring (yes/no) of bleeding sites
Time Frame
Time Frame: baseline, 1, 3 and 6 months after baseline
Title
Change in Plaque Control Record (PCR%)
Description
% assessment of the amount of plaque on dental surfaces; it is detected on 4 surfaces: distal, mesial, vestibular, lingual / palatal. The number of sites with plaque is divided by the total number of sites available in the mouth and multiplied by 100. Results indicate the index as a percentage.
Time Frame
Time Frame: baseline, 1, 3 and 6 months after baseline
Title
Change in Dental mobility (Miller, 1985)
Description
Scoring criteria
Grade 0: oscillation within 0.2 mm; the teeth move naturally and there are no mobility problems;
Grade I: horizontal mobility of the tooth from 0.2 to 1 mm;
Grade II: horizontal mobility of the tooth from 1 to 2 mm;
Grado III: horizontal mobility equal to or greater than 3 mm or vertical mobility of the tooth.
Time Frame
Time Frame: baseline, 1, 3 and 6 months after baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Presence of bilateral periodontal sites according to the new Classification of Periodontal and Peri-implant Diseases (Severity: Staging I; Complexity: Staging II).
No systemic disease;
Compliant patients.
Exclusion Criteria:
Absence of dental implants;
Neurological and psychiatric diseases;
Patients taking bisphosphonates during the previous 12 months from the beginning of the study;
Pregnant and/or breastfeeding women;
Patients undergoing anticancer therapy.
Patients with poor compliance.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Scribante, DDS, PhD, MS
Organizational Affiliation
University of Pavia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia
City
Pavia
State/Province
Lombardy
ZIP/Postal Code
27100
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Data will be available upon motivated request to Principal Investigator.
Learn more about this trial
In-office and Domiciliary Use of a New Ozonized Gel for the Management of Periodontal Disease
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