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Enrolling by invitation NCT06308497

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

No phase Interventional Periodontal Diseases Pregnancy Related

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Probiotic Treatment, Standard Treatment.
Who it may be relevant to
Registry conditions: Periodontal Diseases, Pregnancy Related. Basic parameters: 18 years — 40 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Adjunctive Periodontal Treatment With Coenzyme Q10 in Association With Probiotics for Pregnant Women: Randomized Clinical Trial.

Overview

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

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).

Interventions

  • Other 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®)
  • 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

Primary outcome measures

  • Change in Plaque Index [Time frame: Baseline, 1, 3 and 6 months]
  • Change in Recession (R) [Time frame: Baseline, 1, 3 and 6 months]
  • Change in Clinical Attachment Loss (CAL) [Time frame: Baseline, 1, 3 and 6 months]
  • Change in Bleeding on Probing (BoP) [Time frame: Baseline, 1, 3 and 6 months]
  • Change in Probing Pocket Depth (PPD) [Time frame: Baseline, 1, 3 and 6 months]
  • Change in API - Approximal Plaque Index [Time frame: Baseline, 1, 3 and 6 months]
  • Change in Plaque Control Record (PCR%) [Time frame: Baseline, 1, 3 and 6 months]
  • Change in Papillary Marginal Gingival Index (PMGI) [Time frame: Baseline, 1, 3 and 6 months]
  • Change in modified Marginal Gingival Index (mMGI) [Time frame: Baseline, 1, 3 and 6 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Italy · 1 center
  • Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnost — Pavia

Identifiers

NCT: NCT06308497 · 2024-Q10PREGNANT

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗