- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04809831
The Use of Biorepair Peribioma Toothpaste and Mousse for Home Oral Care in Patients Undergoing Periodontal Therapy
A Comparison Between Biorepair Peribioma Toothpaste and Mousse Versus Chlorhexidine 0,2% Toothpaste (Curasept Trattamento Rigenerante) for Domiciliary Oral Care in Periodontal Patients.
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Lombardy
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Pavia, Lombardy, Italy, 27100
- Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Patients with cardiac pacemaker
- Patients suffering from neurological disorders
- Patients suffering from psychological disorders
- Pregnant women
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Trial Group - Biorepair Peribioma Toothpaste + Mousse
Domiciliary oral hygiene with Biorepair Peribioma Toothpaste in association with Peribioma Mousse twice a day until T2 session.
|
Patients will use Biorepair Peribioma Toothpaste and Mousse for domiciliary oral hygiene twice a day until T2 session.
|
Active Comparator: Control Group - Curasept Toothpaste (chlorhexidine 0,2%)
Domiciliary oral care with Curasept Toothpaste (chlorhexidine 0,2%) twice a day until T2 session.
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Patients will use Curasept Toothpaste (chlorhexidine 0,2%) for domiciliary oral hygiene twice a day until T2 session.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in BOP - Bleeding on Probing (percentage)
Time Frame: 3 and 6 months.
|
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%. |
3 and 6 months.
|
Change in BS - Bleeding Score
Time Frame: 3 and 6 months.
|
Scoring criteria:
|
3 and 6 months.
|
Change in SBI - Sulculus Bleeding Index (Muhulemann and Son, 1781)
Time Frame: 3 and 6 months.
|
Scoring criteria:
|
3 and 6 months.
|
Change in GI - Gingival Index (Loe and Silness, 1963)
Time Frame: 3 and 6 months.
|
Scoring criteria:
|
3 and 6 months.
|
Change in PPD - Probing Pocket Depth
Time Frame: 3 and 6 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 or periodontal pocket, evaluated at 6 sites.
|
3 and 6 months.
|
Change in CAL - Clinical Attachment Loss
Time Frame: 3 and 6 months.
|
Measurement (in mm) of the position of the gingival margin in relation to the cemento-enamel junction (CEJ).
|
3 and 6 months.
|
Change in Percentage of pathological sites
Time Frame: 3 and 6 months.
|
Evaluation of the presence of pathological probes expressed as a percentage.
|
3 and 6 months.
|
Change in R - Gingival recession
Time Frame: 3 and 6 months.
|
Distance (in mm) between the gingival margin and the amelo-cemental junction.
|
3 and 6 months.
|
Change in PI - Plaque Index (Silness and Löe, 1964)
Time Frame: 3 and 6 months.
|
Scoring criteria:
|
3 and 6 months.
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Change in Evaluation of the total height of the adherent gingiva
Time Frame: 3 and 6 months.
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Evaluation (in mm) of the total height of adherent gingiva.
|
3 and 6 months.
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Change in API - Approximal Plaque Index (Lange, 1986)
Time Frame: 3 and 6 months.
|
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).
|
3 and 6 months.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-PERIBIOMA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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