About this trial
This randomized controlled clinical trial aims to evaluate the effectiveness of adjunctive coenzyme Q10 and probiotic supplementation (Limosilactobacillus reuteri Prodentis®) in improving periodontal health in pregnant women undergoing non-surgical periodontal therapy. Forty participants will be randomly assigned to two groups: the test group will receive professional oral hygiene every three months along with a coenzyme Q10-based toothpaste and daily probiotic supplementation; the control group will follow the same protocol without probiotics. The primary outcome is the reduction of the Plaque Index (PI), while secondary outcomes include Bleeding on Probing (BoP), Probing Pocket Depth (PPD), Clinical Attachment Level (CAL), gingival inflammation (MGI, PMGI), plaque distribution (PCR%, API), and gingival recession (R). The study duration is 6 months. The goal is to assess whether this combined therapy can promote a balanced oral microbiota and enhance periodontal health during pregnancy.
Eligibility criteria
Qualifiers
Pregnant women between the 4th and 8th month of gestation
Age ≥ 18 years
Able to understand and communicate in Italian and/or English
Willing to provide written informed consent
Disqualifiers
Presence of cardiac pacemakers
Diagnosed psychological, neurological, or psychiatric disorders
Ongoing oncological therapy
Use of bisphosphonates within the last 12 months
Trial design
Treatments tested in this trial
- Limosilactobacillus reuteri Prodentis®
- Coenzyme Q10 Toothpaste