Viewing Study NCT05812391



Ignite Creation Date: 2024-05-06 @ 6:52 PM
Last Modification Date: 2024-10-26 @ 2:56 PM
Study NCT ID: NCT05812391
Status: ACTIVE_NOT_RECRUITING
Last Update Posted: 2023-04-19
First Post: 2023-04-02

Brief Title: Impact of Full Mouth Erythritol Powder Air Polishing on Systemic Inflammatory Response
Sponsor: University of Baghdad
Organization: University of Baghdad

Study Overview

Official Title: Systemic Inflammatory Response Following Full Mouth Erythritol Powder Air Polishing and Instrumentation A Randomized Clinical Trial
Status: ACTIVE_NOT_RECRUITING
Status Verified Date: 2023-04
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: None
Brief Summary: Periodontitis PD is an inflammatory condition that affects 20-50 of the total global population with severe disease occurring in 98 of individuals clinically characterized by clinical attachment loss CAL and bleeding on probing BOP accompanied by increased probing pocket depth PPD andor gingival recession it may end with tooth loss if left untreated non-surgical periodontal treatment NSPT represents the first line of treatment and involves the physical debridement of subgingival plaque biofilms full-mouth debridement FMD approach its NSPT delivers complete debridement within 24 hr However full-mouth NSPT has been consistently shown to trigger a large systemic inflammatory response 24 hr following treatment Nevertheless Interestingly a positive correlation between treatment time and the subsequent systemic inflammatory response has been reported Given this previous link and the different features of each instrumentation technique including air-polishing devices APDs that have less time-consuming treatment reduce patient discomfort and sensitivity and only minor alterations to surrounding soft and hard tissues This study aims to evaluate the systemic inflammatory response following full-mouth erythritol powder air polishing and instrumentation
Detailed Description: Periodontitis is a common chronic inflammatory disease caused by specific oral dysbiosis and characterized by a progressive loss of soft and hard tissues keeping the teeth if left untreated it leads not only to tooth loss negative influences on the patients quality of life and masticatory impairment may happen There is significant evidence of clinical improvements in PD patients following non-surgical periodontal treatment NSPT including gains in clinical attachment level reductions in gingival inflammation and reduced periodontal pocket depths

A conventional Full-mouth hand debridement has been consistently shown to trigger a large systemic inflammatory mediator The reasons for such a response may be related to both the transient post-operative bacteremia and the extension of the operative trauma

a recent joint consensus statement advised against full-mouth debridement for some medically compromised patients

The erythritol powder is a water-soluble non-toxic sugar alcohol and artificial sweetener has a mean particle size of 14 μm and can be used for supra and subgingival removal of biofilm and stains

It has also been suggested that teeth with sites of furcation involvement andor with reduced access which have traditionally been difficult to debride with conventional instrumentation may benefit from air-flow therapy

Comparing full-mouth ultrasonic debridement with polishing paste and full-mouth erythritol powder air polishing followed by ultrasonic debridement this study hypothesized that the later procedure may reduce the extent of systemic inflammatory mediators they induce by removing the biofilm before the conventional full-mouth supra and sub-gingival ultrasonic debridement

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