Adjunctive Periodontal Treatment With Coenzyme Q10 in Association With Probiotics for Pregnant Women
NCT ID: NCT06308497
Last Updated: 2025-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
40 participants
INTERVENTIONAL
2024-03-10
2025-10-20
Brief Summary
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Detailed Description
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At the first visit, periodontal parameters will be recorded: Plaque Index (PI), recession (R) Bleeding on Probing (BoP), modified Marginal Gingival Index (mMGI), Papillary Marginal Gingival (PMGI), Plaque Control Record ( PCR %), Approximal Plaque Index (API), Clinical Attachment loss (CAL) and Probing Pocket Depth (PPD).
Professional debridement will be conducted with piezoelectric instrumentation and air-flow administration with glycine powders.
Subsequently, patients will be randomly divided into two groups:
* the Probiotic group, in which patients will undergo daily probiotic supplementation in addition to the standard treatment
* the Control group, in which patients will undergo standard treatment
Professional debridement will be repeated every 3 months. Periodontal index evaluation will be conducted at the baseline (T0), after 1 month (T1), after 3 months (T2), and after 6 months (T3).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Trial Group
Patients within this group will undergo probiotic supplementation in addition to standard treatment
Probiotic Treatment
Professional in-office debridement every 3 months Use of soft-picks® advanced interdental cleaners (Gum®) followed by toothbrushing with ActiVital toothpaste (Gum®) with coenzyme Q10 and sonic daily electric toothbrush (Gum®) twice a day Probiotic supplementation with daily assumption of Limosilactobacillus Reuteri Prodentis® tablet (PerioBalance, Gum®)
Control Group
Patients within this group will undergo standard treatment
Standard Treatment
Professional in-office debridement every 3 months Use of soft-picks® advanced interdental cleaners (Gum®) followed by toothbrushing with ActiVital toothpaste (Gum®) with coenzyme Q10 and sonic daily electric toothbrush (Gum®) twice a day
Interventions
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Probiotic Treatment
Professional in-office debridement every 3 months Use of soft-picks® advanced interdental cleaners (Gum®) followed by toothbrushing with ActiVital toothpaste (Gum®) with coenzyme Q10 and sonic daily electric toothbrush (Gum®) twice a day Probiotic supplementation with daily assumption of Limosilactobacillus Reuteri Prodentis® tablet (PerioBalance, Gum®)
Standard Treatment
Professional in-office debridement every 3 months Use of soft-picks® advanced interdental cleaners (Gum®) followed by toothbrushing with ActiVital toothpaste (Gum®) with coenzyme Q10 and sonic daily electric toothbrush (Gum®) twice a day
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* neurological and psychiatric diseases
* patients taking bisphosphonates during the previous 12 months from the beginning of the study
* patients undergoing anticancer therapy.
* patients with poor compliance.
18 Years
40 Years
FEMALE
No
Sponsors
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University of Pavia
OTHER
Responsible Party
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Andrea Scribante
Associate Professor, Principal Investigator
Principal Investigators
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Andrea Scribante, DDS, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pavia
Locations
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Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia
Pavia, Lombardy, Italy
Countries
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Other Identifiers
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2024-Q10PREGNANT
Identifier Type: -
Identifier Source: org_study_id
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