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Clinical Trials/NCT06293911
NCT06293911CompletedNot Applicable

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

University of Pavia2 sites in 1 country40 target enrollmentStarted: March 15, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
40
Locations
2
Primary Endpoint
Change in Bleeding on Probing (BOP%)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • lack of compliance signalled by caregivers
  • other systemic diseases

Outcomes

Primary Outcomes

Change in Bleeding on Probing (BOP%)

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

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

Change in Plaque Control Record (PCR%)

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

% 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.

Change in product satisfaction

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

* 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.

Change in Dental mobility

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

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.

Change in compliance

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

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.

Change in Modified Gingival Index

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

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Andrea Scribante

Associate Professor, Principal Investigator

University of Pavia

Study Sites (2)

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