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

Primary Purpose

Pregnant Woman

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Sonicare DiamondClean 9000 Philips®
HydroSonic Easy Curaden®
Manual toothbrush Oral-B 123
Manual toothbrush Curaprox CS 5460
Sponsored by
Claude Bernard University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pregnant Woman focused on measuring manual toothbrush, electric sonic toothbrush, oral prophylaxis, pregnant woman, gingival inflammation

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept 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: 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    Group using sonic toothbrush

    Group using hydrosonic toothbrush

    Group using manual toothbrush with 5460 strands

    Group using manual toothbrush

    Arm Description

    Patient will be asked to use a sonic toothbrush for 3 months

    Patient will be asked to use a hydrosonic toothbrush for 3 months

    Patients will be asked to use a manual toothbrush with 5460 strands for 3 months

    Patients will be asked to use a manual toothbrush for 3 months

    Outcomes

    Primary Outcome Measures

    Incidence of gingival bleeding from baseline during woman pregnancy
    Change of gingival inflammation in pregnant woman using manual or electric toothbrushes in daily practice

    Secondary Outcome Measures

    Effect on gingival bleeding
    Bleeding on Probing
    Effect on gingival inflammation
    gingival index
    Effect on dental plaque
    plaque index
    Effect on gingival attachment
    clinical attachment loss
    Effect on Periodontal Pocket
    Periodontal Pocket Probing Depth
    Customer Satisfaction Score
    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

    Full Information

    First Posted
    July 6, 2023
    Last Updated
    October 10, 2023
    Sponsor
    Claude Bernard University
    Collaborators
    University of Nancy, Elsan
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05945225
    Brief Title
    Pregnancy Women and Individual Oral Prophylaxis in the Control of Gingival Inflammation (PRE-IOP)
    Acronym
    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

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 1, 2023 (Anticipated)
    Primary Completion Date
    March 30, 2024 (Anticipated)
    Study Completion Date
    March 30, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Claude Bernard University
    Collaborators
    University of Nancy, Elsan

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pregnant Woman
    Keywords
    manual toothbrush, electric sonic toothbrush, oral prophylaxis, pregnant woman, gingival inflammation

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group using sonic toothbrush
    Arm Type
    Experimental
    Arm Description
    Patient will be asked to use a sonic toothbrush for 3 months
    Arm Title
    Group using hydrosonic toothbrush
    Arm Type
    Experimental
    Arm Description
    Patient will be asked to use a hydrosonic toothbrush for 3 months
    Arm Title
    Group using manual toothbrush with 5460 strands
    Arm Type
    Experimental
    Arm Description
    Patients will be asked to use a manual toothbrush with 5460 strands for 3 months
    Arm Title
    Group using manual toothbrush
    Arm Type
    Placebo Comparator
    Arm Description
    Patients will be asked to use a manual toothbrush for 3 months
    Intervention Type
    Device
    Intervention Name(s)
    Sonicare DiamondClean 9000 Philips®
    Intervention Description
    Brush teeth with the electric toothbrush daily during 3 months
    Intervention Type
    Device
    Intervention Name(s)
    HydroSonic Easy Curaden®
    Intervention Description
    Brush teeth with the hydrosonic toothbrush daily during 3 months
    Intervention Type
    Device
    Intervention Name(s)
    Manual toothbrush Oral-B 123
    Intervention Description
    Brush teeth with the manual toothbrush daily during 3 months
    Intervention Type
    Device
    Intervention Name(s)
    Manual toothbrush Curaprox CS 5460
    Intervention Description
    Brush teeth with the manual toothbrush daily during 3 months
    Primary Outcome Measure Information:
    Title
    Incidence of gingival bleeding from baseline during woman pregnancy
    Description
    Change of gingival inflammation in pregnant woman using manual or electric toothbrushes in daily practice
    Time Frame
    T1 (Baseline), T2 (+ 1 month) and T3 (+ 3 months)
    Secondary Outcome Measure Information:
    Title
    Effect on gingival bleeding
    Description
    Bleeding on Probing
    Time Frame
    T1 (Baseline), T2 (+ 1 month) and T3 (+ 3 months)
    Title
    Effect on gingival inflammation
    Description
    gingival index
    Time Frame
    T1 (Baseline), T2 (+ 1 month) and T3 (+ 3 months)
    Title
    Effect on dental plaque
    Description
    plaque index
    Time Frame
    T1 (Baseline), T2 (+ 1 month) and T3 (+ 3 months)
    Title
    Effect on gingival attachment
    Description
    clinical attachment loss
    Time Frame
    T1 (Baseline), T2 (+ 1 month) and T3 (+ 3 months)
    Title
    Effect on Periodontal Pocket
    Description
    Periodontal Pocket Probing Depth
    Time Frame
    T1 (Baseline), T2 (+ 1 month) and T3 (+ 3 months)
    Title
    Customer Satisfaction Score
    Description
    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
    Time Frame
    T1 (Baseline), T2 (+ 1 month) and T3 (+ 3 months)

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    Pregnant women
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Florence Carrouel, PhD
    Phone
    0478785745
    Ext
    +33
    Email
    florence.carrouel@univ-lyon1.fr

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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