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

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

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.

Study Overview

• Status: Completed
• Conditions: Down Syndrome; Gingival Bleeding
• Intervention / Treatment: Other: Biorepair Plus Parodontgel Intensive; Other: Placebo gel

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Turin, Italy, 10128
    • S.C. Odontostomatologia - Azienda Ospedaliera "Ordine Mauriziano di Torino"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• lack of compliance signalled by caregivers
• other systemic diseases

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Postbiotic group	Other: Biorepair Plus Parodontgel Intensive; The Biorepair Plus Parodontgel Intensive gel will be used after home oral hygiene once a day.
Active Comparator: Placebo group	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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: 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)
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)

Collaborators and Investigators

• Sponsor: University of Pavia
• Investigators: Principal Investigator: Andrea Scribante, DDS, PhD, University of Pavia

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2024
• Primary Completion (Actual): December 10, 2024
• Study Completion (Actual): December 17, 2024

Study Registration Dates

• First Submitted: February 25, 2024
• First Submitted That Met QC Criteria: March 1, 2024
• First Posted (Actual): March 5, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 17, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Nervous System Diseases; Pathologic Processes; Genetic Diseases, Inborn; Infections; Disease; Neurobehavioral Manifestations; Hemorrhage; Congenital Abnormalities; Gingival Diseases; Abnormalities, Multiple; Intellectual Disability; Chromosome Disorders; Oral Hemorrhage; Syndrome; Inflammation; Gingivitis; Gingival Hemorrhage; Down Syndrome
• Other Study ID Numbers: 2024-POSTBIOTICSDOWNSYNDROME

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be available upon motivated request to the Principal Investigator.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No