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

University of Pavia

Status: Invitation-only

Conditions: Pregnancy Related; Periodontal Diseases

Treatments: Other: Standard Treatment; Other: Probiotic Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT06308497

2024-Q10PREGNANT

Details and patient eligibility

About

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.

Full 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).

Enrollment: 40 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

Trial Group

Experimental group

Description:

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

Treatment:

Other: Probiotic Treatment

Control Group

Active Comparator group

Description:

Patients within this group will undergo standard treatment

Treatment:

Other: Standard Treatment