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

Change in Bleeding on Probing (BOP%)

Dichotomous scoring (yes/no) of bleeding sites on 4 surfaces of teeth.

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: 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: * 0 to 2: Poor compliance; * 3 to 5: Sufficient compliance; * 6 to 8: Good compliance; * 9 to 10: Excellent compliance.

Time frame: Baseline (T0), after 1 month (T1), 3 months (T2) and after 6 months (T3)

Change in product satisfaction

* Product liking questionnaire: evaluation of taste, smell, consistency, persistence and ease of application by Visual Analogue Scale (VAS) and filling out a questionnaire to which a score from 0 to 10 is associated, of which: * 0: Insufficient; * 1 to 3: Sufficient; * 4 to 6: Good; * 7 to 9: Very Good; * 10: Excellent.

Time frame: Baseline (T0), after 1 month (T1), 3 months (T2) and after 6 months (T3)