Impact of Full Mouth Erythritol Powder Air Polishing on Systemic Inflammatory Response

Systemic Inflammatory Response Following Full Mouth Erythritol Powder Air Polishing and Instrumentation: A Randomized Clinical Trial

Periodontitis (PD) is an inflammatory condition that affects 20%-50% of the total global population, with severe disease occurring in 9.8% of individuals. clinically characterized by clinical attachment loss (CAL) and bleeding on probing (BOP) accompanied by increased probing pocket depth (PPD) and/or 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.

Study Overview

• Status: Active, not recruiting
• Conditions: Periodontal Diseases
• Intervention / Treatment: Procedure: test; Procedure: conventional

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 patient's 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 and/or 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 Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iraq
  • Baghdad, Iraq, 10053
    • Mohammed Kalid Ayoob

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Participants who have periodontitis, unstable, at any stage

Exclusion Criteria:

• Participants who are known or suspected high risk for tuberculosis
• Participants who have hepatitis B or HIV infections
• Participants who are being unable to provide written, informed consent
• Participants who have history of bleeding diathesis
• Participants who are pregnant or intended to and lactating mother.
• Participants who are self-reported diagnosis of any systemic illnesses including cardiovascular, renal and liver diseases
• Participants who have regular use of medication to control systemic illness.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: test group; Supra-gingival erythritol powerder air polishing Sub-gingival erythritol powerder air polishing Supra-gingival debridement Sub-gingival debridement	Procedure: test; the treatment start with supra-gingival erythritol powerder air polishing followed by sub-gingival erythritol powerder air polishing,supra-gingival debridement and sub-gingival debridement
Active Comparator: conventional group; Supra-gingival debridement Sub-gingival debridement Polishing with polishing paste	Procedure: conventional; the treatment start with supra-gingival debridement followed by sub-gingival debridement then finished with polishing paste

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in serum level of C-reactive protein	Change in serum level of C-reactive protein 24 hours following the full mouth debridement	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment time	Evaluate the effect of treatment time (minute) on clinical parameters after 30 days	30 days
Change in percentage of bleeding on probing	Change in the percentage of bleeding on probing 30 days after treatment	30 days
Change in mean probing pocket depth	Change in mean probing pocket depth (mm) 30 days after treatment	30 days
Change in clinical attachment loss	Change in clinical attachment loss (mm)30 days after treatment	30 days
Change in percentage of plaque index	Change in percentage of plaque index 30 days after treatment	30 days

Collaborators and Investigators

• Sponsor: University of Baghdad
• Investigators: Principal Investigator: Mohammed K Ayoob, University of Baghdad

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2023
• Primary Completion (Anticipated): March 1, 2024
• Study Completion (Anticipated): October 1, 2024

Study Registration Dates

• First Submitted: April 2, 2023
• First Submitted That Met QC Criteria: April 2, 2023
• First Posted (Actual): April 13, 2023

Study Record Updates

• Last Update Posted (Actual): April 19, 2023
• Last Update Submitted That Met QC Criteria: April 16, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Periodontitis; Air-polishing; Periodontal disease; Air abrasion; Tooth polishing
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Periodontal Diseases
• Other Study ID Numbers: 745622

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No