Clinical trial NCT05945225: Pregnancy Women and Individual Oral Prophylaxis in the Control of Gingival Inflammation (PRE-IOP)
Official title: 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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Pregnant Woman
Keywords: manual toothbrush
electric sonic toothbrush
oral prophylaxis
pregnant woman
gingival inflammation
Lead sponsor: Claude Bernard University
Sponsor class: OTHER
Collaborators: name: University of Nancy
name: Elsan
First posted: 2023-07-14
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of gingival bleeding from baseline during woman pregnancy
timeFrame: T1 (Baseline), T2 (+ 1 month) and T3 (+ 3 months)
Secondary outcomes:
measure: Effect on gingival bleeding
timeFrame: T1 (Baseline), T2 (+ 1 month) and T3 (+ 3 months)
measure: Effect on gingival inflammation
timeFrame: T1 (Baseline), T2 (+ 1 month) and T3 (+ 3 months)
measure: Effect on dental plaque
timeFrame: T1 (Baseline), T2 (+ 1 month) and T3 (+ 3 months)
measure: Effect on gingival attachment
timeFrame: T1 (Baseline), T2 (+ 1 month) and T3 (+ 3 months)
measure: Effect on Periodontal Pocket
timeFrame: T1 (Baseline), T2 (+ 1 month) and T3 (+ 3 months)
measure: Customer Satisfaction Score
timeFrame: T1 (Baseline), T2 (+ 1 month) and T3 (+ 3 months)
Other outcomes:
Locations:
city: Nancy
country: France
facility: Clinique Majorelle
Study officials:
References: