Pregnancy Women and Individual Oral Prophylaxis in the Control of Gingival Inflammation (PRE-IOP)

Sponsor

Claude Bernard University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05945225

Collaborator

University of Nancy (Other), Elsan (Other)

120

Enrollment

Arms

30.9

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pregnant Woman	Device: Sonicare DiamondClean 9000 Philips® Device: HydroSonic Easy Curaden® Device: Manual toothbrush Oral-B 123 Device: Manual toothbrush Curaprox CS 5460	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

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

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Mar 30, 2024

Anticipated Study Completion Date :

Mar 30, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group using sonic toothbrush Patient will be asked to use a sonic toothbrush for 9 months	Device: Sonicare DiamondClean 9000 Philips® Brush teeth with the electric toothbrush daily during 3 months
Experimental: Group using hydrosonic toothbrush Patient will be asked to use a hydrosonic toothbrush for 9 months	Device: HydroSonic Easy Curaden® Brush teeth with the hydrosonic toothbrush daily during 3 months
Experimental: Group using manual toothbrush with 5460 strands Patients will be asked to use a manual toothbrush with 5460 strands for 9 months	Device: Manual toothbrush Curaprox CS 5460 Brush teeth with the manual toothbrush daily during 3 months
Placebo Comparator: Group using manual toothbrush Patients will be asked to use a manual toothbrush for 9 months	Device: Manual toothbrush Oral-B 123 Brush teeth with the manual toothbrush daily during 3 months

Outcome Measures

Primary Outcome Measures

Incidence of gingival bleeding from baseline during woman pregnancy [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 Outcome Measures

Effect on gingival bleeding [T1 (Baseline), T2 (+ 1 month) and T3 (+ 3 months)]
Bleeding on Probing
Effect on gingival inflammation [T1 (Baseline), T2 (+ 1 month) and T3 (+ 3 months)]
gingival index
Effect on dental plaque [T1 (Baseline), T2 (+ 1 month) and T3 (+ 3 months)]
plaque index
Effect on gingival attachment [T1 (Baseline), T2 (+ 1 month) and T3 (+ 3 months)]
clinical attachment loss
Effect on Periodontal Pocket [T1 (Baseline), T2 (+ 1 month) and T3 (+ 3 months)]
Periodontal Pocket Probing Depth
Customer Satisfaction Score [T1 (Baseline), T2 (+ 1 month) and T3 (+ 3 months)]
the minimum and maximum values: 1, 7 lower scores mean a worse outcome. the minimum and maximum values: 1, 7 lower scores mean a worse outcome. the minimum and maximum values: 1, 7 lower scores mean a worse outcome. The score range from 1 (minimum) to 7 (maximum). Lower score mean a worse outcome

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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:

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