Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia
Pavia, Lombardy, 27100, Italy
NCT Number: NCT04781478
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.
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Notify Me18 year–70 year
All sexes
Interventional
Not applicable
Pavia, Lombardy, 27100, Italy
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:
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
1.1 Severity from grade I onwards (grade I: clinical attachment loss of 1-2 mm, bone loss in the cervical third greater than 15%, no elements loss for periodontitis);
1.2. Complexity from grade II onwards (grade II: maximum probing depth of 5 mm, bone loss mainly horizontally);
Exclusion criteria
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).
Time frame: 1, 3 and 6 months.
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.
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.
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.
% 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.
It is classified using numerical values:
Time frame: 1, 3 and 6 months.
Comparing the measurements of periodontal indices in the two groups for the two different periodontal gels administered.
University of Pavia
Other
Home Oral Care With Biorepair Implant Bioactive Gel and Chlorhexidine Gel 1% for the Improvement of Inflammatory Epidemiological Indices in Periodontal Patients: a Split-mouth Randomised Clinical Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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