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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:
Indexes will be re-evaluated after 1 (T1), 3 (T2) and 6 months. The professional mechanical debridement will be performed again at T3 timepoint.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Postbiotic group | Experimental |
| |
| Placebo group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biorepair Plus Parodontgel Intensive | Other | The Biorepair Plus Parodontgel Intensive gel will be used after home oral hygiene once a day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Bleeding on Probing (BOP%) | Dichotomous scoring (yes/no) of bleeding sites on 4 surfaces of teeth. | Baseline (T0), after 1 month (T1), 3 months (T2) and after 6 months (T3) |
| Change in Plaque Control Record (PCR%) | % 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. | Baseline (T0), after 1 month (T1), 3 months (T2) and after 6 months (T3) |
| Change in Dental mobility | Scoring criteria Grade 0: oscillation within 0.2 mm; the teeth move naturally and there are no mobility problems; Grade I: horizontal mobility of the tooth from 0.2 to 1 mm; Grade II: horizontal mobility of the tooth from 1 to 2 mm; Grado III: horizontal mobility equal to or greater than 3 mm or vertical mobility of the tooth. | Baseline (T0), after 1 month (T1), 3 months (T2) and after 6 months (T3) |
| Change in Modified Gingival Index | Scoring criteria (one measurement for each tooth: upper first incisors, first premolars/first primary molars and first molars): 0. Absence of inflammation Mild inflammation (marginal or papillary unit) Mild inflammation (entire marginal and papillary unit) Moderate inflammation Severe inflammation | Baseline (T0), after 1 month (T1), 3 months (T2) and after 6 months (T3) |
| Change in compliance | Subjective evaluation of the patient's degree of compliance with the proposed treatment by Visual Analogue Scale (VAS), assessing compliance with dosage, alterations and modifications on lifestyle, and adherence to set recalls; to which is associated a score from 0 to 10 of which:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrea Scribante, DDS, PhD | University of Pavia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| S.C. Odontostomatologia - Azienda Ospedaliera "Ordine Mauriziano di Torino" | Turin | 10128 | Italy |
Data will be available upon motivated request to the Principal Investigator.
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| ID | Term |
|---|---|
| D004314 | Down Syndrome |
| D005884 | Gingival Hemorrhage |
| ID | Term |
|---|---|
| D008607 | Intellectual Disability |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| Placebo gel | Other | The placebo gel (without hyaluronic acid, Lactobacillus Ferment, Aloe Barbadensis Leaf Juice Powder and lactoferrin) will be used after home oral hygiene once a day. |
|
| Baseline (T0), after 1 month (T1), 3 months (T2) and after 6 months (T3) |
| Change in product satisfaction |
| Baseline (T0), after 1 month (T1), 3 months (T2) and after 6 months (T3) |
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D025063 | Chromosome Disorders |
| D030342 | Genetic Diseases, Inborn |
| D006472 | Oral Hemorrhage |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |