Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06293911
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-04-26
First Post:
2024-02-25
Brief Title:
Clinical Comparison of a Postbiotic-gel With Placebo Gel for Gingival Inflammation in Patients With Down Syndrome
Sponsor:
University of Pavia
Organization:
University of Pavia
Study Overview
Official Title:
Clinical Comparison of a Postbiotic-gel With Placebo Gel for Gingival Inflammation in Patients With Down Syndrome Randomized Clinical Trial
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 SC Odontostomatologia dellAzienda 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
Patients will be enrolled at the SC Odontostomatologia dellAzienda 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None