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.
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
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
40
Patients will use Biorepair Peribioma Toothpaste and Mousse for domiciliary oral hygiene twice a day until T2 session.
Patients will use Curasept Toothpaste (chlorhexidine 0,2%) for domiciliary oral hygiene twice a day until T2 session.
Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia
Pavia, Lombardy, Italy
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%.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 3 and 6 months.
Change in CAL - Clinical Attachment Loss
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Measurement (in mm) of the position of the gingival margin in relation to the cemento-enamel junction (CEJ).
Time frame: 3 and 6 months.
Change in Percentage of pathological sites
Evaluation of the presence of pathological probes expressed as a percentage.
Time frame: 3 and 6 months.
Change in R - Gingival recession
Distance (in mm) between the gingival margin and the amelo-cemental junction.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 3 and 6 months.