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Clinical Comparison of a Postbiotic-gel With Placebo Gel for Gingival Inflammation in Patients With Down Syndrome: Randomized Clinical Trial
The aim of the study is to evaluate the efficacy of home treatment with a postbiotic-based gel for the management of periodontal inflammation in patients with Down syndrome. Patients will be enrolled at the S.C. Odontostomatologia dell'Azienda Ospedaliera "Ordine Mauriziano di Torino", Turin, Italy. After the collection of the periodontal clinical indexes (BoP%, PCR%, dental mobility, mMGI, compliance and satisfaction questionnaire), patients will undergo a professional mechanical debridement with ultrasonic instruments and glycine powders. Then, they will be randomly divided into two groups according to the home treatment: * in the Trial group Biorepair Plus Parodontgel Intensive (containing microRepair®, hyaluronic acid, Lactobacillus Ferment and Aloe Barbadensis Leaf Juice Powder) will be used once a day for all the duration of the study * in the Control group, a placebo gel without (active ingredients) will be used once a day for all the duration of the study. Indexes will be re-evaluated after 1 (T1), 3 (T2) and 6 months. The professional mechanical debridement will be performed again at T3 timepoint.
Age
18 - 70 years
Sex
ALL
Healthy Volunteers
No
S.C. Odontostomatologia - Azienda Ospedaliera "Ordine Mauriziano di Torino"
Turin, Italy
Start Date
March 15, 2024
Primary Completion Date
December 10, 2024
Completion Date
December 17, 2024
Last Updated
December 18, 2024
40
ACTUAL participants
Biorepair Plus Parodontgel Intensive
OTHER
Placebo gel
OTHER
Lead Sponsor
University of Pavia
NCT04726241
NCT07234695
Data Source & Attribution
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