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

NCT04809831 | Completed

• 1 other identifier: 2021-PERIBIOMA
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontal Diseases

Keywords

dental hygiene; periodontal non-surgical therapy; split-mouth

Outcome Measures

Primary Outcomes (11)

• 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%.

  3 and 6 months.

• 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.

  3 and 6 months.

• 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.

  3 and 6 months.

• 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.

  3 and 6 months.

• 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.

  3 and 6 months.

• Change in CAL - Clinical Attachment Loss

  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

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

  3 and 6 months.

• Change in R - Gingival recession

  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)

  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.

  3 and 6 months.

• Change in Evaluation of the total height of the adherent gingiva

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

  3 and 6 months.

• 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).

  3 and 6 months.

Study Arms (2)

Trial Group - Biorepair Peribioma Toothpaste + Mousse

ACTIVE COMPARATOR

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

Other: Domiciliary oral care with Biorepair Peribioma Toothpaste + Mousse

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

ACTIVE COMPARATOR

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

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

Interventions

Domiciliary oral care with Biorepair Peribioma Toothpaste + Mousse OTHER

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

Trial Group - Biorepair Peribioma Toothpaste + Mousse

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.

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Pavia: lead

Study Sites (1)

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

Pavia, Lombardy, 27100, Italy

Location

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Officials

• Andrea Scribante, DDS, PhD.

  University of Pavia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Resident, Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: March 16, 2021
• First Posted: March 22, 2021
• Study Start: March 22, 2021
• Primary Completion: October 29, 2021
• Study Completion: November 3, 2021
• Last Updated: January 13, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)