Clinical Trials Logo

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT06293911
Other study ID # 2024-POSTBIOTICSDOWNSYNDROME
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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)
See also
  Status Clinical Trial Phase
Recruiting NCT04854122 - Blood Flow Regulation in Individuals With Down Syndrome - Training Study N/A
Completed NCT04020302 - Self-Monitoring Shopping Intervention N/A
Recruiting NCT01950624 - DS-Connect {TM}: The Down Syndrome Registry
Completed NCT04751136 - the Effect of Cerebrolysin on Physical and Mental Functions of Down Syndrome Phase 2
Completed NCT04767412 - Inspiratory Muscle Training and Physical Fitness in Children With Down Syndrome Randomized Control Trial N/A
Completed NCT04536506 - Bobath and Vojta Therapy for DS N/A
Not yet recruiting NCT04037579 - Protocol for a Non-randomized Survey in Down Syndrome People Who Practice Sports. Self and Observers´ Perception.
Completed NCT02882698 - Performance Analysis in Down Syndrome on Mobile Phone N/A
Completed NCT01791725 - A 4-Week Safety Study of Oral ELND005 in Young Adults With Down Syndrome Without Dementia Phase 2
Unknown status NCT01975545 - Fluor Varnish With Silver Nanoparticles for Dental Remineralization in Patients With Trisomy 21 Phase 2
Completed NCT01808508 - Obstructive Sleep Apnea and Neurocognitive and Cardiovascular Function in Children With Down Syndrome N/A
Terminated NCT00754052 - Evaluating The Efficacy And Safety Of Donepezil Hydrochloride (Aricept) In The Treatment Of The Cognitive Dysfunction Exhibited By Children With Down Syndrome, Aged 11 To 17 Phase 3
Terminated NCT00754013 - Evaluating The Efficacy And Safety Of Donepezil Hydrochloride (Aricept) In The Treatment Of The Cognitive Dysfunction Exhibited By Children With Down Syndrome, Aged 6 To 10 Phase 3
Completed NCT01313325 - Hippotherapy to Improve the Balance of Children With Movement Disorders N/A
Completed NCT01256112 - Parent Supported Weight Reduction in Down Syndrome N/A
Completed NCT01594346 - Multicenter Vitamin E Trial in Aging Persons With Down Syndrome Phase 3
Completed NCT05343468 - Life Skills Improved in Children With Down Syndrome After Using Assistive Technology N/A
Suspended NCT05755464 - Evaluation of Patients With Down Syndrome Compliance to Dental Therapy
Recruiting NCT04022460 - Using Personal Mobile Technology to Identify Obstructive Sleep Apnea in Children With Down Syndrome (UPLOAD)
Completed NCT04818437 - Effect of Core Stability Exercises and Balance Training in Postural Control Among Down Syndrome N/A