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

Pregnancy Related Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06308497
• Other study ID #: 2024-Q10PREGNANT
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 10, 2024
• Est. completion date: October 20, 2024

Study information

• Verified date: April 2024
• Source: University of Pavia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: October 20, 2024
• Est. primary completion date: October 15, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Periodontal Diseases
• Pregnancy Related

Intervention

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®)
• 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

Locations

Country	Name	City	State
Italy	Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia	Pavia	Lombardy

Sponsors (1)

Lead Sponsor	Collaborator
University of Pavia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Plaque Index	Scoring criteria: 0 = no plaque; = thin plaque layer at the gingival margin, only detectable by scraping with a probe; = moderate layer of plaque along the gingival margin; interdental spaces free, but plaque is visible to the naked eye; = abundant plaque along the gingival margin; interdental spaces filled with plaque.	Baseline, 1, 3 and 6 months
Primary	Change in Recession (R)	Distance (in mm) between the gingival margin and the amelo-cemental junction.	Baseline, 1, 3 and 6 months
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Change in modified Marginal Gingival Index (mMGI)	Scoring criteria: 0 = Absence of inflammation; = Mild inflammation (marginal or papillary unit); = Mild inflammation (entire marginal and papillary unit); = Moderate inflammation; = Severe inflammation	Baseline, 1, 3 and 6 months