Peri-implant MucositisNCT04845087
Management of Peri-implant Mucositis With Ozone Water Jet: a Randomized Clinical Trial.
A study testing Ozonized water in people with Peri-implant Mucositis, run by University of Pavia at 1 site in Italy.
Trial summary
The aim of this study is to assess if ozonized water can be used for the treatment of peri-implant mucositis in patients with dental implants. Patients willl undergo professional dental hygiene also with the use of glycine powders, then they will be randomly divided into two groups: Trial Group: irrigation of… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Peri-implant Mucositis
- What is being tested?
- Ozonized water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteItaly
- Study dates
- 24 Apr 2021to 8 Jul 2021
- 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 one or more dental implants
- Presence of peri-implant mucositis at least at one implant
- Bleeding Score > 0
Who cannot join
- Patents without dental implants
- Presence of systemic diseases
- Patients with cardiac pacemaker
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: Pilot Study for the Management of Peri-implant Mucositis With Ozone Water Jet: a Randomized Clinical Trial.
The aim of this study is to assess if ozonized water can be used for the treatment of peri-implant mucositis in patients with dental implants.
Patients willl undergo professional dental hygiene also with the use of glycine powders, then they will be randomly divided into two groups:
- Trial Group: irrigation of peri-implant periodontium with mucositis with ozonized water.
- Placebo Group: irrigation of peri-implant periodontium with mucositis with water.
Periodontal indices will be recorded at the baseline, after 1 and 2 months. After 1 and 2 months, only glycine powders will be performed, together with ozonized water or water irrigation and the collection of periodontal indices.
Read the detailed description
The aim of this study is to assess if ozonized water can be used for the treatment of peri-implant mucositis in patients with dental implants.
Patients who respond to eligibility criteria and that will sign the informed consent will undergo a professional oral hygiene procedure.
Patients willl undergo professional dental hygiene also with the use of glycine powders. Then, glycine powders air-flow will be administered. Then they will be randomly divided into two groups:
- Trial Group: irrigation of peri-implant periodontium with mucositis with ozonized water.
- Placebo Group: irrigation of peri-implant periodontium with mucositis with water.
Periodontal indices will be recorded at the baseline, after 1 and 2 months. After 1 and 2 months, only glycine powder will be performed, together with ozonized water/water irrigation and the collection of periodontal indices.
- Conditions
- Peri-implant Mucositis
- Being tested
- Ozonized water, Placebo
- Keywords
- ozonized water
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ozonized waterOther
Irrigation of dental implants with ozonized water
PlaceboOther
Irrigation of dental implants with water
| Study group | Role | What they receive |
|---|---|---|
| Trial Group | Experimental | Patients from this group will receive treatment with ozonized water. Receives: Other: Ozonized water |
| Placebo Group | Placebo comparator | Patients from this group will receive placebo with water. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PPD - Probing 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 of the peri-implant pocket, evaluated at 6 sites.
Measured: Baseline, 1 and 2 months.
Change in BOP - Bleeding on Probing (percentage)
Site-specific assessment of the presence or absence of gum bleeding after the insertion of the periodontal probe for the detection of PD, detected on 6 sites.
Measured: Baseline, 1 and 2 months.
Change in BS - Bleeding Score
Scoring criteria:
- 0: no bleeding;
- 1: punctiform bleeding in the site of probing;
- 2: bleeding within the gingival border;
- 3: bleeding outside the gingival border.
Measured: Baseline, 1 and 2 months.
Change in PI - Plaque Index (percentage)
Site-specific assessment of the presence or visible plaque detected on 4 sites with a disclosing tables.
Percentage of sites with plaque determines the PI%.
Measured: Baseline, 1 and 2 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2021
- Study start24 Apr 2021
- Primary completion6 Jul 2021
- Study completion8 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-implant MucositisStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 26 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., Principal investigator, University of Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04845087
- Sponsor's protocol ID
- 2021-AQUALAB
- Status last verified
- Jul 2021
- First submitted
- 13 Apr 2021
- Last updated
- 9 Jul 2021
- Results posted
- 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 9 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study for the Management of Peri-implant Mucositis With Ozone Water Jet: a Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT04845087
- Acronym / sponsor ID
- 2021-AQUALAB
- Conditions
- Peri-implant Mucositis
- Keywords
- ozonized water
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Study start
- 24 Apr 2021 (actual)
- Primary completion
- 6 Jul 2021 (actual)
- Study completion
- 8 Jul 2021 (actual)
- First posted
- 14 Apr 2021 (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 assess if ozonized water can be used for the treatment of peri-implant mucositis in patients with dental implants.
Patients willl undergo professional dental hygiene also with the use of glycine powders, then they will be randomly divided into two groups:
- Trial Group: irrigation of peri-implant periodontium with mucositis with ozonized water.
- Placebo Group: irrigation of peri-implant periodontium with mucositis with water.
Periodontal indices will be recorded at the baseline, after 1 and 2 months. After 1 and 2 months, only glycine powders will be performed, together with ozonized water or water irrigation and the collection of periodontal indices.
Detailed description
The aim of this study is to assess if ozonized water can be used for the treatment of peri-implant mucositis in patients with dental implants.
Patients who respond to eligibility criteria and that will sign the informed consent will undergo a professional oral hygiene procedure.
Patients willl undergo professional dental hygiene also with the use of glycine powders. Then, glycine powders air-flow will be administered. Then they will be randomly divided into two groups:
- Trial Group: irrigation of peri-implant periodontium with mucositis with ozonized water.
- Placebo Group: irrigation of peri-implant periodontium with mucositis with water.
Periodontal indices will be recorded at the baseline, after 1 and 2 months. After 1 and 2 months, only glycine powder will be performed, together with ozonized water/water irrigation and the collection of periodontal indices.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trial Group | Experimental | Other: Ozonized waterPatients from this group will receive treatment with ozonized water. |
| Placebo Group | Placebo comparator | Other: PlaceboPatients from this group will receive placebo with water. |
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 one or more dental implants
- Presence of peri-implant mucositis at least at one implant
- Bleeding Score > 0
Key exclusion criteria (3 listed)
- Patents without dental implants
- Presence of systemic diseases
- Patients with cardiac pacemaker
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 |
|---|---|---|
| Ozonized waterIrrigation of dental implants with ozonized water | Other | Trial Group |
| PlaceboIrrigation of dental implants with water | Other | Placebo Group |
Primary outcome
Change in PPD - Probing Depth
Time frame: Baseline, 1 and 2 months.
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 of the peri-implant pocket, evaluated at 6 sites.
Change in BOP - Bleeding on Probing (percentage)
Time frame: Baseline, 1 and 2 months.
Site-specific assessment of the presence or absence of gum bleeding after the insertion of the periodontal probe for the detection of PD, detected on 6 sites.
Change in BS - Bleeding Score
Time frame: Baseline, 1 and 2 months.
Scoring criteria: * 0: no bleeding; * 1: punctiform bleeding in the site of probing; * 2: bleeding within the gingival border; * 3: bleeding outside the gingival border.
Change in PI - Plaque Index (percentage)
Time frame: Baseline, 1 and 2 months.
Site-specific assessment of the presence or visible plaque detected on 4 sites with a disclosing tables. Percentage of sites with plaque determines the PI%.
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 9 Jul 2021.
- 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. 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 Ozonized water in people with Peri-implant Mucositis, 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 3 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 9 Jul 2021. 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. Some participants in this study may receive a placebo. 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 PPD - Probing Depth (time frame: Baseline, 1 and 2 months.). The study lists 4 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 9 Jul 2021.