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

Not Applicable

• Conditions: Pregnant Woman

• Registration Number: NCT05945225
• Lead Sponsor: Claude Bernard University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-7-6
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Enrolling by invitation
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

Inclusion Criteria:<br><br> - Female, 18 to 40 years of age<br><br> - 15-18 weeks pregnant<br><br> - Acceptance of study terms and conditions<br><br> - Signature of informed consent form<br><br>Exclusion Criteria:<br><br> - Protected women<br><br> - Stage II,III periodontal disease (i.e. PD = 4 mm, and/or CAL = 4 mm), generalized<br> (>30% od sites)<br><br> - History or treatment of periodontal disease<br><br> - Current dental or orthodontic treatment<br><br> - Fewer than 20 natural teeth, excluding third molars<br><br> - Taking medication affecting the gums and/or oral mucosa<br><br> - Regular use (more than once a week) of interdental brushes and/or dental floss<br> and/or mouthwash<br><br> - Removable prosthesis<br><br> - Dental implants<br><br> - Systemic disorder such as blood disorders, diabetes, and risk of endocarditis<br> infections<br><br> - Anticoagulant treatment<br><br> - Inability to follow protocol or non-cooperation

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of gingival bleeding from baseline during woman pregnancy

Secondary Outcome Measures

Name	Time	Method
Effect on gingival bleeding;Effect on gingival inflammation;Effect on dental plaque;Effect on gingival attachment;Effect on Periodontal Pocket;Customer Satisfaction Score