An interventional study of Biorepair Plus Parodontgel Intensive and Placebo gel in Down Syndrome and Gingival Bleeding, sponsored by University of Pavia. Completed at 1 site in Italy. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-12-18.
Sponsored by University of Pavia · Not applicable, Interventional, and Treatment
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:
Indexes will be re-evaluated after 1 (T1), 3 (T2) and 6 months. The professional mechanical debridement will be performed again at T3 timepoint.
590 studies on the registry are indexed under Gingivitis; 104 are open to participants now.
This study's enrollment of 40 is below the median of 64 across 478 interventional studies indexed under Gingivitis.
Browse Gingivitis studies →University of Pavia is the lead sponsor of 141 studies on the registry; 39 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other: Biorepair Plus Parodontgel Intensive
Other: Placebo gel
The Biorepair Plus Parodontgel Intensive gel will be used after home oral hygiene once a day.
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.
Change in Bleeding on Probing (BOP%)
Dichotomous scoring (yes/no) of bleeding sites on 4 surfaces of teeth.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: Baseline (T0), after 1 month (T1), 3 months (T2) and after 6 months (T3)
Plan to share: No — Data will be available upon motivated request to the Principal Investigator.
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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University of Pavia