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

Down Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06293911
• Other study ID #: 2024-POSTBIOTICSDOWNSYNDROME
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 15, 2024
• Est. completion date: July 28, 2025

Study information

• Verified date: April 2024
• Source: University of Pavia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: July 28, 2025
• Est. primary completion date: July 17, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• not bedridden patients with Down syndrome

• gingival inflammation and bleeding

Exclusion Criteria:

• lack of compliance signalled by caregivers

• other systemic diseases

Related Conditions & MeSH terms

• Down Syndrome
• Gingival Bleeding
• Gingival Hemorrhage
• Gingivitis
• Inflammation
• Syndrome

Intervention

Other:
• Biorepair Plus Parodontgel Intensive
The Biorepair Plus Parodontgel Intensive gel will be used after home oral hygiene once a day.
• Placebo gel
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.

Locations

Country	Name	City	State
Italy	S.C. Odontostomatologia - Azienda Ospedaliera "Ordine Mauriziano di Torino"	Turin

Sponsors (1)

Lead Sponsor	Collaborator
University of Pavia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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.	Baseline (T0), after 1 month (T1), 3 months (T2) and after 6 months (T3)
Primary	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.	Baseline (T0), after 1 month (T1), 3 months (T2) and after 6 months (T3)