Ignite Creation Date:
2024-05-06 @ 7:14 PM
Last Modification Date:
2024-10-26 @ 3:03 PM
Study NCT ID:
NCT05945225
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-02-06
First Post:
2023-07-06
Brief Title:
Pregnancy Women and Individual Oral Prophylaxis in the Control of Gingival Inflammation PRE-IOP
Sponsor:
Claude Bernard University
Organization:
Claude Bernard University
Study Overview
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
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRE-IOP
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None