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

NCT06293911 | Completed

• 1 other identifier: 2024-POSTBIOTICSDOWNSYNDROME
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Down Syndrome; Gingival Bleeding

Outcome Measures

Primary Outcomes (6)

• 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)

Study Arms (2)

Postbiotic group

EXPERIMENTAL

Other: Biorepair Plus Parodontgel Intensive

Placebo group

ACTIVE COMPARATOR

Other: Placebo gel

Interventions

Biorepair Plus Parodontgel Intensive OTHER

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

Postbiotic group

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.

Placebo group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• lack of compliance signalled by caregivers
• other systemic diseases

Sponsors & Collaborators

• University of Pavia: lead

Study Sites (1)

S.C. Odontostomatologia - Azienda Ospedaliera "Ordine Mauriziano di Torino"

Turin, 10128, Italy

Location

MeSH Terms

Conditions

Down Syndrome; Gingival Hemorrhage

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn; Oral Hemorrhage; Mouth Diseases; Stomatognathic Diseases; Gingival Diseases; Periodontal Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Andrea Scribante, DDS, PhD

  University of Pavia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Principal Investigator

Study Record Dates

• First Submitted: February 25, 2024
• First Posted: March 5, 2024
• Study Start: March 15, 2024
• Primary Completion: December 10, 2024
• Study Completion: December 17, 2024
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)