Clinical trial NCT06308497: Adjunctive Periodontal Treatment With Coenzyme Q10 in Association With Probiotics for Pregnant Women
Official title: Adjunctive Periodontal Treatment With Coenzyme Q10 in Association With Probiotics for Pregnant Women: Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Periodontal Diseases
Pregnancy Related
Lead sponsor: University of Pavia
Sponsor class: OTHER
First posted: 2024-03-13
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-arm parallel design
Primary purpose: TREATMENT

Brief 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).

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.

Primary outcomes:
measure: Change in Plaque Index
timeFrame: Baseline, 1, 3 and 6 months
measure: Change in Recession (R)
timeFrame: Baseline, 1, 3 and 6 months
measure: Change in Clinical Attachment Loss (CAL)
timeFrame: Baseline, 1, 3 and 6 months
measure: Change in Bleeding on Probing (BoP)
timeFrame: Baseline, 1, 3 and 6 months
measure: Change in Probing Pocket Depth (PPD)
timeFrame: Baseline, 1, 3 and 6 months
measure: Change in API - Approximal Plaque Index
timeFrame: Baseline, 1, 3 and 6 months
measure: Change in Plaque Control Record (PCR%)
timeFrame: Baseline, 1, 3 and 6 months
measure: Change in Papillary Marginal Gingival Index (PMGI)
timeFrame: Baseline, 1, 3 and 6 months
measure: Change in modified Marginal Gingival Index (mMGI)
timeFrame: Baseline, 1, 3 and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia
state: Lombardy
Study officials:
affiliation: University of Pavia
name: Andrea Scribante, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References: