This study is an open-label split-mouth study in which periodontal patients will be treated in order to obtain periodontal health. After non-surgical therapy and air-perio polishing, a periodontal in-situ gelling product (Biorepair Implant Bioactive gel) will be applied in periodontal pockets in two quadrants (Q1-Q3 or Q2-Q4) of the mouth of the participants. At the same time, pockets of the contralateral quadrant will be irrigated with chlorhexidine gel 1%. Patients will continue to use gels at home for the following 14 days and on the same quadrants. Professional ora hygiene session will be performed after 1, 3 and 6 months from the baseline. Patients are divided into two groups with inverted quadrants administration in order to evaluate the improvements of periodontal inflammation indices and to assess the efficacy of Biorepair Implant Bioactive gel compared to chlorhexidine 1% gel treatment.
This study is an open-label split-mouth study that aims to assess the improvement of periodontal inflammatory indices after sessions of professional oral hygiene with the administration of Biorepair Implant Bioactive Gel and Chlorhexidine gel 1%. It will also compare the efficacy of the two gel in rebalancing periodontal health. Periodontal patients that will give the informed consent to the treatment protocol and that satisfy the eligibility criteria will undergo 4 sessions of professional oral hygiene. For each session, periodontal inflammatory indices will be recorded and professional manual and mechanical removal of supragingival and subgingival deposits of both arches will be performed, following air-perio polishing with glycine powders. At this stage, patients will be randomized and allocated to the following two groups: * Group 1: application in periodontal pockets of quadrants Q1 and Q3 of Biorepair Implant Bioactive Gel; irrigation of periodontal pockets of quadrants Q2 and Q4 with chlorhexidine 1% gel. * Group 2: irrigation of periodontal pockets of quadrants Q1 and Q3 with chlorhexidine 1% gel; application in periodontal pockets of quadrants Q2 and Q4 of Biorepair Implant Bioactive Gel. Patients will continue with a home oral care protocol, using both gels for the same quadrants of their group for the following 14 days after the professional oral hygiene session. The first session is at the baseline (T0), the second is after 1 month (T1), the third is after 3 months (T2) and the last is after 6 months (T4).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
30
Professional application of Biorepair Gel after Scaling and Root Planing and Air-Perio polishing (glycine powders).
Irrigation of periodontal pockets with Chlorhexidine 1.00% gel afterScaling and Root Planing and Air-Perio polishing (glycine powders).
Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia
Pavia, Lombardy, Italy
BOP% - Bleeding on Probing %
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: 1, 3 and 6 months.
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: 1, 3 and 6 months.
R - Gingival recession
Evaluation (in mm) of the distance between the gingival margin and the amelo-cemental junction (JEC). It is the exposure of the root surface, following the apical migration of periodontal structure.
Time frame: 1, 3 and 6 months.
PCR% - Plaque Control Record
% assessment of the amount of plaque on dental surfaces; it is detected on 4 surfaces: distal, mesial, vestibular, lingual / palatal. The number of sites with plaque is divided by the total number of sites available in the mouth and multiplied by 100. Results indicate the index as a percentage.
Time frame: 1, 3 and 6 months.
Dental mobility (Miller, 1985)
It is classified using numerical values: 0\. Grade 0: oscillation within 0.2 mm; the teeth move naturally and there are no mobility problems; 1. Grade I: horizontal mobility of the tooth from 0.2 to 1 mm; 2. Grade II: horizontal mobility of the tooth from 1 to 2 mm; 3. Grado III: horizontal mobility equal to or greater than 3 mm or vertical mobility of the tooth.
Time frame: 1, 3 and 6 months.
Comparison between biorepair gel and chlorhexidine 1% gel
Comparing the measurements of periodontal indices in the two groups for the two different periodontal gels administered.
Time frame: 1, 3 and 6 months.
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