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Peri-implant MucositisNCT05256914

Ozonized In-office and Domiciliary Gels vs Chlorhexidine Gel 1% for the Management of Peri-implant Mucositis Sites

A study testing Ozoral Pro and Ozoral gel administration and Curasept chlorhexidine gel 1% in people with Peri-implant Mucositis, run by University of Pavia at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a split-mouth randomized controlled clinical trial (RCT). 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… Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Peri-implant Mucositis
What is being tested?
Ozoral Pro and Ozoral gel administration and Curasept chlorhexidine gel 1%
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteItaly
Study dates
27 Feb 2022to 6 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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

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

Other trials in Italy

About this study

Official title: Ozonized In-office and Domiciliary Gels vs Chlorhexidine Gel 1% for the Management of Peri-implant Mucositis Sites: a Randomized Clinical Trial.

This is a split-mouth randomized controlled clinical trial (RCT). 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:

Read more
  • 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 6 months. Patients will be visited at: T0, after 1 month from T0 (T1), after 3 months (T2), after 6 months (T3). Professional hygiene will be performed again at T2 and T3.

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.

Read the detailed description

This is a split-mouth randomized controlled clinical trial (RCT). 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 6 months. Patients will be visited at: T0, after 1 month from T0 (T1), after 3 months (T2), and after 6 months (T3). At T2 and T3, 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)

Being tested
Ozoral Pro and Ozoral gel administration, Curasept chlorhexidine gel 1%

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ozoral Pro and Ozoral gel administrationOther

    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%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).

Study groups in NCT05256914
Study groupRoleWhat they receive
Peri-implant mucositis sitesExperimentalPeri-implant mucositis sites will be randomly assigned to ozone treatment.
Receives: Other: Ozoral Pro and Ozoral gel administration
Contralateral peri-implant mucositis sitesExperimentalContralateral peri-implant mucositis sites with respect to those treated with ozone will be assigned to chlorhexidine treatment.
Receives: Other: Curasept chlorhexidine gel 1%

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Bleeding on Probing (BOP%)

    Dichotomous scoring (yes/no) of bleeding sites

    Measured: Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3)

  2. 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

    Measured: Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3)

  3. Change in Suppuration (%)

    Dichotomous scoring (yes/no) of suppurating sites

    Measured: Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3)

  4. 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

    Measured: Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3)

  5. Change in mucosal margin

    Dichotomous scoring (migrated/non migrated)

    Measured: Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3)

  6. 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.

    Measured: Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3)

  7. 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

    Measured: Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3)

  8. 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

    Measured: Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Feb 2022
  2. Study start27 Feb 2022
  3. Primary completion3 Oct 2022
  4. Study completion6 Oct 2022

Resources

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 design
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05256914
Sponsor's protocol ID
2022-OZORAL6MONTHS
Status last verified
Oct 2022
First submitted
16 Feb 2022
Last updated
7 Oct 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Data are available upon motivated request to the Authors.

Questions about this trial

What is this clinical trial studying?

A study testing Ozoral Pro and Ozoral gel administration and Curasept chlorhexidine gel 1% 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 4 inclusion and 5 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 7 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 Bleeding on Probing (BOP%) (time frame: Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05256914.

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 7 Oct 2022.

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