Adjunctive Periodontal Treatment With Coenzyme Q10 in Association With Probiotics for Pregnant Women

NCT ID: NCT06308497

Last Updated: 2025-01-22

Study Results

Results pending

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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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-10

Study Completion Date

2025-10-20

Brief Summary

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The aim of the study is to assess if probiotic supplementation can be effective in reducing periodontal clinical parameters in a 6-month study on pregnant patients.

Detailed Description

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The aim of the study is to assess if probiotic supplementation can be effective in reducing periodontal clinical parameters in a 6-month study on pregnant patients. Patients' enrollment will be conducted according to inclusion criteria.

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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Periodontal Diseases Pregnancy Related

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double-arm parallel design
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
Products will be concealed.

Study Groups

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Trial Group

Patients within this group will undergo probiotic supplementation in addition to standard treatment

Group Type EXPERIMENTAL

Probiotic Treatment

Intervention Type OTHER

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

Group Type ACTIVE_COMPARATOR

Standard Treatment

Intervention Type OTHER

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®)

Intervention Type OTHER

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* women at the 4th month of pregnancy

Exclusion Criteria

* presence of cardiac pacemaker
* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Pavia

OTHER

Sponsor Role lead

Responsible Party

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Andrea Scribante

Associate Professor, Principal Investigator

Responsibility Role 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

Site Status

Countries

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Italy

Other Identifiers

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2024-Q10PREGNANT

Identifier Type: -

Identifier Source: org_study_id

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