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

Not Applicable

• Conditions: Pregnancy Related; Periodontal Diseases

• Registration Number: NCT06308497
• Lead Sponsor: University of Pavia

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).

Study Timeline

• Study First Submitted: 2024-03-01
• Study First Submitted QC: 2024-03-06
• Study Start: 2024-03-10
• Study First Posted: 2024-03-13
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-19
• Last Update Posted: 2025-01-22
• Primary Completion: 2025-10-15
• Study Completion: 2025-10-20

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Clinical Attachment Loss (CAL)	Baseline, 1, 3 and 6 months	Measurement (in mm) of the position of the gingival margin in relation to the cemento-enamel junction (CEJ).
Change in Plaque Index	Baseline, 1, 3 and 6 months	Scoring criteria: 0 = no plaque; 1. = thin plaque layer at the gingival margin, only detectable by scraping with a probe; 2. = moderate layer of plaque along the gingival margin; interdental spaces free, but plaque is visible to the naked eye; 3. = abundant plaque along the gingival margin; interdental spaces filled with plaque.
Change in Recession (R)	Baseline, 1, 3 and 6 months	Distance (in mm) between the gingival margin and the amelo-cemental junction.
Change in Bleeding on Probing (BoP)	Baseline, 1, 3 and 6 months	Site-specific assessment of the presence or absence of gum bleeding after the insertion of the periodontal probe for the detection of PPD, detected on 6 sites.; Percentage of sites with bleeding on probing determines the BOP%.
Change in Papillary Marginal Gingival Index (PMGI)	Baseline, 1, 3 and 6 months	Numerical score from 0 to 3 of gingival inflammation. Papille and gingival margins (vestibular and lingual) are given a score from 0 to 3. The score is given by the total amount of inflamed sites on the total of examined sites.
Change in modified Marginal Gingival Index (mMGI)	Baseline, 1, 3 and 6 months	Scoring criteria: 0 = Absence of inflammation; 1. = Mild inflammation (marginal or papillary unit); 2. = Mild inflammation (entire marginal and papillary unit); 3. = Moderate inflammation; 4. = Severe inflammation
Change in Probing Pocket Depth (PPD)	Baseline, 1, 3 and 6 months	Evaluation (in mm) of the depth of the gingival sulcus, through a millimeter periodontal probe; it is detected from the gingival margin to the bottom of the gingival sulcus or periodontal pocket, evaluated at 6 sites.
Change in API - Approximal Plaque Index	Baseline, 1, 3 and 6 months	Following application of disclosing, a simple yes/no decision is made concerning whether the interproximal surfaces are covered by plaque (+) or not (-). The proportion of plaque-covered interproximal spaces is expressed as a percentage. Usually, in a given quadrant the interproximal spaces are scored from only one aspect (i.e. from the facial - Q2 and Q4 - or from the oral aspect - Q1 and Q3).
Change in Plaque Control Record (PCR%)	Baseline, 1, 3 and 6 months	% assessment of the amount of plaque on dental surfaces; it is detected on 4 surfaces: distal, mesial, vestibular, lingual / palatal. The number of sites with plaque is divided by the total number of sites available in the mouth and multiplied by 100. Results indicate the index as a percentage.

Trial Locations

Locations (1)

Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia; 🇮🇹 Pavia, Lombardy, Italy