Effectiveness of Coenzyme Q10 and Probiotics in Periodontal Therapy During Pregnancy
Trial Parameters
Brief Summary
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
Inclusion Criteria: * 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 * Good compliance and willingness to follow study instructions Exclusion Criteria: * Presence of cardiac pacemakers * Diagnosed psychological, neurological, or psychiatric disorders * Ongoing oncological therapy * Use of bisphosphonates within the last 12 months * Poor motivation or low compliance * Substance abuse (drugs or alcohol) or lifestyle incompatible with study requirements