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

University of Pavia

Status: Completed

Conditions: Periodontal Diseases

Treatments: Other: Domiciliary oral care with Biorepair Peribioma Toothpaste + Mousse; Other: Domiciliary oral care with Curasept Toothpaste (chlorhexidine 0,2%)

Study type: Interventional

Funder types: Other

Identifiers

NCT04809831

2021-PERIBIOMA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups

Trial Group - Biorepair Peribioma Toothpaste + Mousse

Active Comparator group

Description:

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

Treatment:

Other: Domiciliary oral care with Biorepair Peribioma Toothpaste + Mousse

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

Active Comparator group

Description:

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

Treatment:

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