Clinical Comparison of a Postbiotic-gel With Placebo Gel for Gingival Inflammation in Patients With Down Syndrome: Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Pavia
- 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
Andrea Scribante
Associate Professor, Principal Investigator
University of Pavia