Clinical Comparison of a Postbiotic-gel With Placebo Gel for Gingival Inflammation in Patients With Down Syndrome

University of Pavia

Status: Completed

Conditions: Gingival Bleeding; Down Syndrome

Treatments: Other: Placebo gel; Other: Biorepair Plus Parodontgel Intensive

Study type: Interventional

Funder types: Other

Identifiers

NCT06293911

2024-POSTBIOTICSDOWNSYNDROME

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• not bedridden patients with Down syndrome
• gingival inflammation and bleeding

Exclusion criteria

• lack of compliance signalled by caregivers
• other systemic diseases

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups

Postbiotic group

Experimental group

Treatment:

Other: Biorepair Plus Parodontgel Intensive

Placebo group

Active Comparator group

Treatment:

Other: Placebo gel