Down SyndromeNCT06293911
Clinical Comparison of a Postbiotic-gel With Placebo Gel for Gingival Inflammation in Patients With Down Syndrome
A study testing Biorepair Plus Parodontgel Intensive in people with Down Syndrome and Gingival Bleeding, run by University of Pavia at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Down Syndrome, Gingival Bleeding
- What is being tested?
- Biorepair Plus Parodontgel Intensive
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 15 Mar 2024to 17 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- not bedridden patients with Down syndrome
- gingival inflammation and bleeding
Who cannot join
- lack of compliance signalled by caregivers
- other systemic diseases
Trial locations and contacts
1 site in 1 country.
Italy1 site
S.C. Odontostomatologia - Azienda Ospedaliera "Ordine Mauriziano di Torino"
Turin, 10128
About this study
Official title: Clinical Comparison of a Postbiotic-gel With Placebo Gel for Gingival Inflammation in Patients With Down Syndrome: Randomized Clinical Trial
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.
Read more
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
- Being tested
- Biorepair Plus Parodontgel Intensive, Placebo gel
- Medical subject headings
- Down Syndrome, Gingival Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biorepair Plus Parodontgel IntensiveOther
The Biorepair Plus Parodontgel Intensive gel will be used after home oral hygiene once a day.
Placebo gelOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Postbiotic group | Experimental | Not described Receives: Other: Biorepair Plus Parodontgel Intensive |
| Placebo group | Active comparator | Not described Receives: Other: Placebo gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Bleeding on Probing (BOP%)
Dichotomous scoring (yes/no) of bleeding sites on 4 surfaces of teeth.
Measured: 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.
Measured: 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.
Measured: 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):
- Absence of inflammation
Mild inflammation (marginal or papillary unit) Mild inflammation (entire marginal and papillary unit) Moderate inflammation Severe inflammation
Measured: 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.
Measured: 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.
Measured: Baseline (T0), after 1 month (T1), 3 months (T2) and after 6 months (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start15 Mar 2024
- Primary completion10 Dec 2024
- Study completion17 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Down SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Scribante, University of Pavia
- Investigators
- Andrea Scribante, DDS, PhD, Principal investigator, University of Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06293911
- Sponsor's protocol ID
- 2024-POSTBIOTICSDOWNSYNDROME
- Status last verified
- Dec 2024
- First submitted
- 25 Feb 2024
- Last updated
- 18 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be available upon motivated request to the Principal Investigator.
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Comparison of a Postbiotic-gel With Placebo Gel for Gingival Inflammation in Patients With Down Syndrome: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06293911
- Acronym / sponsor ID
- 2024-POSTBIOTICSDOWNSYNDROME
- Conditions
- Down Syndrome, Gingival Bleeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 10 Dec 2024 (actual)
- Study completion
- 17 Dec 2024 (actual)
- First posted
- 5 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Postbiotic group | Experimental | Other: Biorepair Plus Parodontgel Intensive |
| Placebo group | Active comparator | Other: Placebo gel |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- not bedridden patients with Down syndrome
- gingival inflammation and bleeding
Key exclusion criteria (2 listed)
- lack of compliance signalled by caregivers
- other systemic diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biorepair Plus Parodontgel IntensiveThe Biorepair Plus Parodontgel Intensive gel will be used after home oral hygiene once a day. | Other | Postbiotic group |
| Placebo gelThe placebo gel (without hyaluronic acid, Lactobacillus Ferment, Aloe Barbadensis Leaf Juice Powder and lactoferrin) will be used after home oral hygiene once a day. | Other | Placebo group |
Primary outcome
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 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 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
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 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Individual participant dataSharing planned: No. Data will be available upon motivated request to the Principal Investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Scribante, DDS, PhD principal investigator
University of Pavia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biorepair Plus Parodontgel Intensive in people with Down Syndrome and Gingival Bleeding, run by University of Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Bleeding on Probing (BOP%) (time frame: Baseline (T0), after 1 month (T1), 3 months (T2) and after 6 months (T3)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2024.