Clinical Comparison of Two Sonic Electric Toothbrushes and Two Manual Toothbrushes, Used Under Normal Oral Hygiene Conditions, on the Reduction of Gingival Inflammation in Pregnant Women Aged 18 to 40: Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Incidence of gingival bleeding from baseline during woman pregnancy
Study Overview
Brief Summary
Gingivitis in pregnant women is a common inflammatory periodontal disease that appears from the third month of pregnancy with an overall prevalence of 35 to 100%. This condition is induced by oral biofilm and exacerbated by increased levels of sex steroid hormones characteristic of pregnancy. Strict bacterial plaque control with both professional and home oral hygiene is essential. Manual toothbrushes require a more specific manual technique for women, while sonic electric toothbrushes, due to their ease of use, might be an excellent for oral individual prophylaxis. Therefore, the question of which type of manual or electric toothbrush might be more effective in reducing gingival inflammation in pregnant women is still unresolved. In literature there are a large number of in vitro clinical studies on this topic, there are currently no clinical studies investigating this long-term clinical comparison.
In this context, this study is a randomized clinical trial consisting of a comparative evaluation between two manual and two sonic electric toothbrushes in the efficacy of the control of plaque in order to reduce gingivitis in women during the period of pregnancy.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Female, 18 to 40 years of age
- •15-18 weeks pregnant
- •Acceptance of study terms and conditions
- •Signature of informed consent form
Exclusion Criteria
- •Protected women
- •Stage II,III periodontal disease (i.e. PD ≥ 4 mm, and/or CAL ≥ 4 mm), generalized (>30% od sites)
- •History or treatment of periodontal disease
- •Current dental or orthodontic treatment
- •Fewer than 20 natural teeth, excluding third molars
- •Taking medication affecting the gums and/or oral mucosa
- •Regular use (more than once a week) of interdental brushes and/or dental floss and/or mouthwash
- •Removable prosthesis
- •Dental implants
- •Systemic disorder such as blood disorders, diabetes, and risk of endocarditis infections
- •Anticoagulant treatment
- •Inability to follow protocol or non-cooperation
Arms & Interventions
Group using sonic toothbrush
Patient will be asked to use a sonic toothbrush for 3 months
Intervention: Sonicare DiamondClean 9000 Philips® (Device)
Group using hydrosonic toothbrush
Patient will be asked to use a hydrosonic toothbrush for 3 months
Intervention: HydroSonic Easy Curaden® (Device)
Group using manual toothbrush with 5460 strands
Patients will be asked to use a manual toothbrush with 5460 strands for 3 months
Intervention: Manual toothbrush Curaprox CS 5460 (Device)
Group using manual toothbrush
Patients will be asked to use a manual toothbrush for 3 months
Intervention: Manual toothbrush Oral-B 123 (Device)
Outcomes
Primary Outcomes
Incidence of gingival bleeding from baseline during woman pregnancy
Time Frame: T1 (Baseline), T2 (+ 1 month) and T3 (+ 3 months)
Change of gingival inflammation in pregnant woman using manual or electric toothbrushes in daily practice
Secondary Outcomes
- Effect on gingival bleeding(T1 (Baseline), T2 (+ 1 month) and T3 (+ 3 months))
- Effect on Periodontal Pocket(T1 (Baseline), T2 (+ 1 month) and T3 (+ 3 months))
- Customer Satisfaction Score(T1 (Baseline), T2 (+ 1 month) and T3 (+ 3 months))
- Effect on gingival attachment(T1 (Baseline), T2 (+ 1 month) and T3 (+ 3 months))
- Effect on dental plaque(T1 (Baseline), T2 (+ 1 month) and T3 (+ 3 months))
- Effect on gingival inflammation(T1 (Baseline), T2 (+ 1 month) and T3 (+ 3 months))
Investigators
Carrouel Florence
Associate professor
Claude Bernard University