Adjunctive Periodontal Treatment With Coenzyme Q10 in Association With Probiotics for Pregnant Women
- Conditions
- Pregnancy RelatedPeriodontal Diseases
- Interventions
- Other: Probiotic TreatmentOther: Standard Treatment
- 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).
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- Female
- Target Recruitment
- 40
- women at the 4th month of pregnancy
- 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
- Arm && Interventions
Group Intervention Description Trial Group Probiotic Treatment Patients within this group will undergo probiotic supplementation in addition to standard treatment Control Group Standard Treatment Patients within this group will undergo standard treatment
- 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 inflammationChange 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia
🇮🇹Pavia, Lombardy, Italy