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

Официальное название

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

Обзор

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.

Подробное описание

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).

Вмешательства

• Другое 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®)
• Другое 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

Первичные конечные точки

• Change in Plaque Index [Срок оценки: Baseline, 1, 3 and 6 months]
• Change in Recession (R) [Срок оценки: Baseline, 1, 3 and 6 months]
• Change in Clinical Attachment Loss (CAL) [Срок оценки: Baseline, 1, 3 and 6 months]
• Change in Bleeding on Probing (BoP) [Срок оценки: Baseline, 1, 3 and 6 months]
• Change in Probing Pocket Depth (PPD) [Срок оценки: Baseline, 1, 3 and 6 months]
• Change in API - Approximal Plaque Index [Срок оценки: Baseline, 1, 3 and 6 months]
• Change in Plaque Control Record (PCR%) [Срок оценки: Baseline, 1, 3 and 6 months]
• Change in Papillary Marginal Gingival Index (PMGI) [Срок оценки: Baseline, 1, 3 and 6 months]
• Change in modified Marginal Gingival Index (mMGI) [Срок оценки: Baseline, 1, 3 and 6 months]

Критерии участия

Критерии включения

• women at the 4th month of pregnancy

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Италия · 1 центр

• Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnost — Pavia

Идентификаторы

NCT: NCT06308497 · 2024-Q10PREGNANT

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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