NCT06308497

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

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

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University of Pavia · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Periodontal Diseases
• Pregnancy Related

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-03-10
• Primary completion: 2025-10-15
• Completion: 2025-10-20
• First posted: 2024-03-13
• Last updated: 2025-01-22

Locations

1 site across 1 country: Italy