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

Primary Purpose

Periodontal Diseases

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Domiciliary oral care with Biorepair Peribioma Toothpaste + Mousse
Domiciliary oral care with Curasept Toothpaste (chlorhexidine 0,2%)
Sponsored by
University of Pavia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontal Diseases focused on measuring dental hygiene, periodontal non-surgical therapy, split-mouth

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Trial Group - Biorepair Peribioma Toothpaste + Mousse

Control Group - Curasept Toothpaste (chlorhexidine 0,2%)

Arm Description

Domiciliary oral hygiene with Biorepair Peribioma Toothpaste in association with Peribioma Mousse twice a day until T2 session.

Domiciliary oral care with Curasept Toothpaste (chlorhexidine 0,2%) twice a day until T2 session.

Outcomes

Primary Outcome Measures

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%.
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.
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.
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.
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.
Change in CAL - Clinical Attachment Loss
Measurement (in mm) of the position of the gingival margin in relation to the cemento-enamel junction (CEJ).
Change in Percentage of pathological sites
Evaluation of the presence of pathological probes expressed as a percentage.
Change in R - Gingival recession
Distance (in mm) between the gingival margin and the amelo-cemental junction.
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.
Change in Evaluation of the total height of the adherent gingiva
Evaluation (in mm) of the total height of adherent gingiva.
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).

Secondary Outcome Measures

Full Information

First Posted
March 16, 2021
Last Updated
December 23, 2021
Sponsor
University of Pavia
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1. Study Identification

Unique Protocol Identification Number
NCT04809831
Brief Title
The Use of Biorepair Peribioma Toothpaste and Mousse for Home Oral Care in Patients Undergoing Periodontal Therapy
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.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
March 22, 2021 (Actual)
Primary Completion Date
October 29, 2021 (Actual)
Study Completion Date
November 3, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pavia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Diseases
Keywords
dental hygiene, periodontal non-surgical therapy, split-mouth

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Trial Group - Biorepair Peribioma Toothpaste + Mousse
Arm Type
Active Comparator
Arm Description
Domiciliary oral hygiene with Biorepair Peribioma Toothpaste in association with Peribioma Mousse twice a day until T2 session.
Arm Title
Control Group - Curasept Toothpaste (chlorhexidine 0,2%)
Arm Type
Active Comparator
Arm Description
Domiciliary oral care with Curasept Toothpaste (chlorhexidine 0,2%) twice a day until T2 session.
Intervention Type
Other
Intervention Name(s)
Domiciliary oral care with Biorepair Peribioma Toothpaste + Mousse
Intervention Description
Patients will use Biorepair Peribioma Toothpaste and Mousse for domiciliary oral hygiene twice a day until T2 session.
Intervention Type
Other
Intervention Name(s)
Domiciliary oral care with Curasept Toothpaste (chlorhexidine 0,2%)
Intervention Description
Patients will use Curasept Toothpaste (chlorhexidine 0,2%) for domiciliary oral hygiene twice a day until T2 session.
Primary Outcome Measure Information:
Title
Change in BOP - Bleeding on Probing (percentage)
Description
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%.
Time Frame
3 and 6 months.
Title
Change in BS - Bleeding Score
Description
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.
Time Frame
3 and 6 months.
Title
Change in SBI - Sulculus Bleeding Index (Muhulemann and Son, 1781)
Description
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.
Time Frame
3 and 6 months.
Title
Change in GI - Gingival Index (Loe and Silness, 1963)
Description
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.
Time Frame
3 and 6 months.
Title
Change in PPD - Probing Pocket Depth
Description
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.
Time Frame
3 and 6 months.
Title
Change in CAL - Clinical Attachment Loss
Description
Measurement (in mm) of the position of the gingival margin in relation to the cemento-enamel junction (CEJ).
Time Frame
3 and 6 months.
Title
Change in Percentage of pathological sites
Description
Evaluation of the presence of pathological probes expressed as a percentage.
Time Frame
3 and 6 months.
Title
Change in R - Gingival recession
Description
Distance (in mm) between the gingival margin and the amelo-cemental junction.
Time Frame
3 and 6 months.
Title
Change in PI - Plaque Index (Silness and Löe, 1964)
Description
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.
Time Frame
3 and 6 months.
Title
Change in Evaluation of the total height of the adherent gingiva
Description
Evaluation (in mm) of the total height of adherent gingiva.
Time Frame
3 and 6 months.
Title
Change in API - Approximal Plaque Index (Lange, 1986)
Description
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).
Time Frame
3 and 6 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Scribante, DDS, PhD.
Organizational Affiliation
University of Pavia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia
City
Pavia
State/Province
Lombardy
ZIP/Postal Code
27100
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data will be available upon motivated request to Principal Investigator.

Learn more about this trial

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

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