Periodontal DiseasesNCT05254288
In-office and Domiciliary Use of a New Ozonized Gel for the Management of Periodontal Disease
A study testing Chlorhexidine and Ozoral gels in people with Periodontal Diseases, run by University of Pavia at 1 site in Italy.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Periodontal Diseases
- What is being tested?
- Chlorhexidine and Ozoral gels
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 22 Mar 2022to 19 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia
Pavia, Lombardy, 27100
About this study
Official title: Evaluation of a New In-office and Domiciliary Ozonized Gel for the Management of Periodontal Disease
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.
Read the 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.
- Conditions
- Periodontal Diseases
- Being tested
- Chlorhexidine, Ozoral gels
- Keywords
- ozone, chlorhexidine, split-mouth
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChlorhexidineOther
In-office and domiciliary use of chlorhexidine for 14 days.
Ozoral gelsOther
In-office administration of Ozoral Pro and domiciliary use of Ozoral gel for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Split-mouth Group A | Experimental | Half of patients will be assigned to this group. Quadrants Q1/Q4 will receive ozone administration. Quadrants Q2/Q3 will receive chlorhexidine administration. Receives: Other: Chlorhexidine; Other: Ozoral gels |
| Split-mouth Group B | Experimental | Half of patients will be assigned to this group Quadrants Q2/Q3 will receive ozone administration. Quadrants Q1/Q4 will receive chlorhexidine administration. Receives: Other: Chlorhexidine; Other: Ozoral gels |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in R - Gingival recession
Distance (in mm) between the gingival margin and the amelo-cemental junction.
Measured: Time Frame: baseline, 1, 3 and 6 months after baseline
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.
Measured: Time Frame: baseline, 1, 3 and 6 months after baseline
Change in Bleeding on Probing (BOP%)
Dichotomous scoring (yes/no) of bleeding sites
Measured: Time Frame: baseline, 1, 3 and 6 months after baseline
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.
Measured: Time Frame: baseline, 1, 3 and 6 months after baseline
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.
Measured: Time Frame: baseline, 1, 3 and 6 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study start22 Mar 2022
- Primary completion15 Oct 2022
- Study completion19 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Split-mouth
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Scribante, University of Pavia
- Investigators
- Andrea Scribante, DDS, PhD, MS, Principal investigator, University of Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05254288
- Sponsor's protocol ID
- 2022-OZORALPAROD
- Status last verified
- Oct 2022
- First submitted
- 14 Feb 2022
- Last updated
- 20 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be available upon motivated request to Principal Investigator.
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a New In-office and Domiciliary Ozonized Gel for the Management of Periodontal Disease
- ClinicalTrials.gov ID
- NCT05254288
- Acronym / sponsor ID
- 2022-OZORALPAROD
- Conditions
- Periodontal Diseases
- Keywords
- ozone, chlorhexidine, split-mouth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Study start
- 22 Mar 2022 (actual)
- Primary completion
- 15 Oct 2022 (actual)
- Study completion
- 19 Oct 2022 (actual)
- First posted
- 24 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Split-mouth
| Arm | Type | Receives |
|---|---|---|
| Split-mouth Group A | Experimental | Other: Chlorhexidine, Other: Ozoral gelsHalf of patients will be assigned to this group. Quadrants Q1/Q4 will receive ozone administration. Quadrants Q2/Q3 will receive chlorhexidine administration. |
| Split-mouth Group B | Experimental | Other: Chlorhexidine, Other: Ozoral gelsHalf of patients will be assigned to this group Quadrants Q2/Q3 will receive ozone administration. Quadrants Q1/Q4 will receive chlorhexidine administration. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChlorhexidineIn-office and domiciliary use of chlorhexidine for 14 days. | Other | Split-mouth Group A, Split-mouth Group B |
| Ozoral gelsIn-office administration of Ozoral Pro and domiciliary use of Ozoral gel for 14 days. | Other | Split-mouth Group A, Split-mouth Group B |
Primary outcome
Change in R - Gingival recession
Time frame: Time Frame: baseline, 1, 3 and 6 months after baseline
Distance (in mm) between the gingival margin and the amelo-cemental junction.
Change in PPD - Probing Pocket Depth
Time frame: Time Frame: baseline, 1, 3 and 6 months after baseline
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%)
Time frame: Time Frame: baseline, 1, 3 and 6 months after baseline
Dichotomous scoring (yes/no) of bleeding sites
Change in Plaque Control Record (PCR%)
Time frame: Time Frame: baseline, 1, 3 and 6 months after baseline
% 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)
Time frame: Time Frame: baseline, 1, 3 and 6 months after baseline
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2022.
- Individual participant dataSharing planned: No. Data will be available upon motivated request to Principal Investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Scribante, DDS, PhD, MS principal investigator
University of Pavia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chlorhexidine and Ozoral gels in people with Periodontal Diseases, run by University of Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in R - Gingival recession (time frame: Time Frame: baseline, 1, 3 and 6 months after baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2022.