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

NCT06308497 | Enrolling By Invitation

• 1 other identifier: 2024-Q10PREGNANT
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontal Diseases; Pregnancy Related

Outcome Measures

Primary Outcomes (9)

• Change in Plaque Index

  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.

  Baseline, 1, 3 and 6 months

• Change in Recession (R)

  Distance (in mm) between the gingival margin and the amelo-cemental junction.

  Baseline, 1, 3 and 6 months

• Change in Clinical Attachment Loss (CAL)

  Measurement (in mm) of the position of the gingival margin in relation to the cemento-enamel junction (CEJ).

  Baseline, 1, 3 and 6 months

• Change in Bleeding on Probing (BoP)

  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%.

  Baseline, 1, 3 and 6 months

• Change in Probing Pocket Depth (PPD)

  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.

  Baseline, 1, 3 and 6 months

• Change in API - Approximal Plaque Index

  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).

  Baseline, 1, 3 and 6 months

• Change in Plaque Control Record (PCR%)

  % 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.

  Baseline, 1, 3 and 6 months

• Change in Papillary Marginal Gingival Index (PMGI)

  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.

  Baseline, 1, 3 and 6 months

• Change in modified Marginal Gingival Index (mMGI)

  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

  Baseline, 1, 3 and 6 months

Study Arms (2)

Trial Group

EXPERIMENTAL

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

Other: Probiotic Treatment

Control Group

ACTIVE COMPARATOR

Patients within this group will undergo standard treatment

Other: Standard Treatment

Interventions

Probiotic Treatment OTHER

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®)

Trial Group

Standard Treatment OTHER

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

Control Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• women at the 4th month of pregnancy

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pavia: lead

Study Sites (1)

Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia

Pavia, Lombardy, 27100, Italy

Location

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Officials

• Andrea Scribante, DDS, PhD

  University of Pavia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Products will be concealed.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Principal Investigator

Model Details: Double-arm parallel design

Study Record Dates

• First Submitted: March 1, 2024
• First Posted: March 13, 2024
• Study Start: March 10, 2024
• Primary Completion: October 15, 2025
• Study Completion: October 20, 2025
• Last Updated: January 22, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)