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Periodontal DiseasesNCT04809831

The Use of Biorepair Peribioma Toothpaste and Mousse for Home Oral Care in Patients Undergoing Periodontal Therapy

A study testing Domiciliary oral care with Biorepair Peribioma Toothpaste + Mousse and Domiciliary oral care with Curasept Toothpaste (chlorhexidine 0,2%) in people with Periodontal Diseases, 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 clinical trial in which a new domiciliary oral care protocol with Biorepair Peribioma Toothpaste and Mousse is evaluated in periodontal patients. 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?
Domiciliary oral care with Biorepair Peribioma Toothpaste + Mousse and Domiciliary oral care with Curasept Toothpaste (chlorhexidine 0,2%)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteItaly
Study dates
22 Mar 2021to 3 Nov 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 periodontal disease according to the recent 2017 classification (2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions): severity grade II-III and complexity grade I-II.
  • Presence of bilateral periodontal probes, for at least one tooth per side up to 20 elements with pathologic probes).
  • Patients' good compliance

Who cannot join

  • Patients with cardiac pacemaker
  • Patients suffering from neurological disorders
  • Patients suffering from psychological disorders
  • Pregnant women

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: A Comparison Between Biorepair Peribioma Toothpaste and Mousse Versus Chlorhexidine 0,2% Toothpaste (Curasept Trattamento Rigenerante) for Domiciliary Oral Care in Periodontal Patients.

This is a split-mouth randomized clinical trial in which a new domiciliary oral care protocol with Biorepair Peribioma Toothpaste and Mousse is evaluated in periodontal patients.

Read the detailed description

This is a split-mouth randomized clinical trial that aims to suggest an innovative protocol for domiciliary oral care of periodontal patients. In details, home use of Biorepair Peribioma Toothpaste and Mousse is proposed as a support of professional hygiene sessions.

Patients that respond to the eligibility criteria and that sign the informed consent are recruited for periodontal therapy.The first professional hygiene session is performed at the baseline (T0); the following ones will be performed after 3 (T1) and 6 months (T2) from the baseline. In each session, periodontal indices of inflammation are detected; then, subgingival removal of plaque and tartar is performed, followed by glycine air-flow application in periodontal pockets. A microbiological test is perfomed in order to detect red and orange complex bacteria. At this time, patients are randomly allocated into two groups:

  • Trial Group: domiciliary oral hygiene with Biorepair Peribioma Toothpaste and Mousse twice a day until T2 session.
  • Control Group: home oral hygiene with Curasept Toothpaste (0,2% Chlorhexidine) twice a day until T2 session.

At the end of T1 and T2 professional session, a satisfaction survey about Peribioma Toothpaste and Mousse will ben given to the patients.

Being tested
Domiciliary oral care with Biorepair Peribioma Toothpaste + Mousse, Domiciliary oral care with Curasept Toothpaste (chlorhexidine 0,2%)
Keywords
dental hygiene, periodontal non-surgical therapy, 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.

  • Domiciliary oral care with Biorepair Peribioma Toothpaste + MousseOther

    Patients will use Biorepair Peribioma Toothpaste and Mousse for domiciliary oral hygiene twice a day until T2 session.

  • Domiciliary oral care with Curasept Toothpaste (chlorhexidine 0,2%)Other

    Patients will use Curasept Toothpaste (chlorhexidine 0,2%) for domiciliary oral hygiene twice a day until T2 session.

Study groups in NCT04809831
Study groupRoleWhat they receive
Trial Group - Biorepair Peribioma Toothpaste + MousseActive comparatorDomiciliary oral hygiene with Biorepair Peribioma Toothpaste in association with Peribioma Mousse twice a day until T2 session.
Receives: Other: Domiciliary oral care with Biorepair Peribioma Toothpaste + Mousse
Control Group - Curasept Toothpaste (chlorhexidine 0,2%)Active comparatorDomiciliary oral care with Curasept Toothpaste (chlorhexidine 0,2%) twice a day until T2 session.
Receives: Other: Domiciliary oral care with Curasept Toothpaste (chlorhexidine 0,2%)

What is being measured

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

  1. 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 PPD, detected on 6 sites.

    Percentage of sites with bleeding on probing determines the BOP%.

    Measured: 3 and 6 months.

  2. Change in BS - Bleeding Score

    Scoring criteria:

    • 0 = no bleeding;
    • 1 = punctiform bleeding in the site of probing;
    • 2 = slightly extended bleeding in the site of probing;
    • 3 = bleeding in more than a half of gingival margin;
    • 4 = gingival border fully covered by blood.

    Measured: 3 and 6 months.

  3. Change in SBI - Sulculus Bleeding Index (Muhulemann and Son, 1781)

    Scoring criteria:

    • 0 = healthy looking papillary and marginal gingiva, no bleeding on probing;
    • 1 = healthy looking gingiva, with bleeding on probing;
    • 2 = bleeding on probing, change in color, no edema;
    • 3 = bleeding on probing, change in color, slight edema;
    • 4 = bleeding on probing, change in color, obvious edema;
    • 5 = spontaneous bleeding, change in color, marked edema.

    Measured: 3 and 6 months.

  4. Change in GI - Gingival Index (Loe and Silness, 1963)

    Scoring criteria:

    • 0 = normal gingiva.
    • 1 = mild inflammation, edema and swelling; no bleeding.
    • 2 = moderate inflammation with edema, swelling and bleeding on probing.
    • 3 = severe inflammation with marked edema, redness tissues, ulceration and spontaneous bleeding.

    Measured: 3 and 6 months.

  5. 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: 3 and 6 months.

  6. Change in CAL - Clinical Attachment Loss

    Measurement (in mm) of the position of the gingival margin in relation to the cemento-enamel junction (CEJ).

    Measured: 3 and 6 months.

  7. Change in Percentage of pathological sites

    Evaluation of the presence of pathological probes expressed as a percentage.

    Measured: 3 and 6 months.

  8. Change in R - Gingival recession

    Distance (in mm) between the gingival margin and the amelo-cemental junction.

    Measured: 3 and 6 months.

  9. Change in PI - Plaque Index (Silness and Löe, 1964)

    Scoring criteria:

    • 0 = no plaque;
    • 1 = thin plaque layer at the gingival margin, only detectable by scraping with a probe;
    • 2 = moderate layer of plaque along the gingival margin; interdental spaces free, but plaque is visible to the naked eye;
    • 3 = abundant plaque along the gingival margin; interdental spaces filled with plaque.

    Measured: 3 and 6 months.

  10. Change in Evaluation of the total height of the adherent gingiva

    Evaluation (in mm) of the total height of adherent gingiva.

    Measured: 3 and 6 months.

  11. Change in API - Approximal Plaque Index (Lange, 1986)

    Following application of disclosing, a simple yes/no decision is made concerning whether the interproximal surfaces are covered by plaque (+) or not (-). The proportion of plaque-covered interproximal spaces is expressed as a percentage. Usually, in a given quadrant the interproximal spaces are scored from only one aspect (i.e. from the facial - Q2 and Q4 - or from the oral aspect - Q1 and Q3).

    Measured: 3 and 6 months.

Timeline

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

  1. First posted22 Mar 2021
  2. Study start22 Mar 2021
  3. Primary completion29 Oct 2021
  4. Study completion3 Nov 2021

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
This is a study in which patients are divided into two groups: * Trial Group: professional dental hygiene at T0, T1 and T2 + Biorepair Peribioma Toothpaste and Mousse for domiciliary oral care twice a day until T2; * Control Group: professional dental hygiene at T0, T1 and T2 + Curasept Toothpaste with chlorhexidine 0,2% twice a day until T2.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04809831
Sponsor's protocol ID
2021-PERIBIOMA
Status last verified
Dec 2021
First submitted
16 Mar 2021
Last updated
13 Jan 2022
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.

Questions about this trial

What is this clinical trial studying?

A study testing Domiciliary oral care with Biorepair Peribioma Toothpaste + Mousse and Domiciliary oral care with Curasept Toothpaste (chlorhexidine 0,2%) 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 4 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 13 Jan 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 BOP - Bleeding on Probing (percentage) (time frame: 3 and 6 months.). The study lists 11 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 NCT04809831.

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 13 Jan 2022.

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