Clinical trial NCT04809831: 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
Overall status: COMPLETED
Phase: NA
Conditions: Periodontal Diseases
Keywords: dental hygiene
periodontal non-surgical therapy
split-mouth
Lead sponsor: University of Pavia
Sponsor class: OTHER
First posted: 2021-03-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in BOP - Bleeding on Probing (percentage)
timeFrame: 3 and 6 months.
measure: Change in BS - Bleeding Score
timeFrame: 3 and 6 months.
measure: Change in SBI - Sulculus Bleeding Index (Muhulemann and Son, 1781)
timeFrame: 3 and 6 months.
measure: Change in GI - Gingival Index (Loe and Silness, 1963)
timeFrame: 3 and 6 months.
measure: Change in PPD - Probing Pocket Depth
timeFrame: 3 and 6 months.
measure: Change in CAL - Clinical Attachment Loss
timeFrame: 3 and 6 months.
measure: Change in Percentage of pathological sites
timeFrame: 3 and 6 months.
measure: Change in R - Gingival recession
timeFrame: 3 and 6 months.
measure: Change in PI - Plaque Index (Silness and Löe, 1964)
timeFrame: 3 and 6 months.
measure: Change in Evaluation of the total height of the adherent gingiva
timeFrame: 3 and 6 months.
measure: Change in API - Approximal Plaque Index (Lange, 1986)
timeFrame: 3 and 6 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia
state: Lombardy
Study officials:
affiliation: University of Pavia
name: Andrea Scribante, DDS, PhD.
role: PRINCIPAL_INVESTIGATOR
References: