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

Primary Purpose

Periodontal Diseases

Status
Active
Phase
Not Applicable
Locations
Iraq
Study Type
Interventional
Intervention
test
conventional
Sponsored by
University of Baghdad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Periodontal Diseases focused on measuring Periodontal disease, Periodontitis, Air abrasion, Tooth polishing, Air-polishing

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Mohammed Kalid Ayoob

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

test group

conventional group

Arm Description

Supra-gingival erythritol powerder air polishing Sub-gingival erythritol powerder air polishing Supra-gingival debridement Sub-gingival debridement

Supra-gingival debridement Sub-gingival debridement Polishing with polishing paste

Outcomes

Primary Outcome Measures

Change in serum level of C-reactive protein
Change in serum level of C-reactive protein 24 hours following the full mouth debridement

Secondary Outcome Measures

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

Full Information

First Posted
April 2, 2023
Last Updated
April 16, 2023
Sponsor
University of Baghdad
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1. Study Identification

Unique Protocol Identification Number
NCT05812391
Brief Title
Impact of Full Mouth Erythritol Powder Air Polishing on Systemic Inflammatory Response
Official Title
Systemic Inflammatory Response Following Full Mouth Erythritol Powder Air Polishing and Instrumentation: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 10, 2023 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Baghdad

4. Oversight

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

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Diseases
Keywords
Periodontal disease, Periodontitis, Air abrasion, Tooth polishing, Air-polishing

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
test group
Arm Type
Active Comparator
Arm Description
Supra-gingival erythritol powerder air polishing Sub-gingival erythritol powerder air polishing Supra-gingival debridement Sub-gingival debridement
Arm Title
conventional group
Arm Type
Active Comparator
Arm Description
Supra-gingival debridement Sub-gingival debridement Polishing with polishing paste
Intervention Type
Procedure
Intervention Name(s)
test
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
conventional
Intervention Description
the treatment start with supra-gingival debridement followed by sub-gingival debridement then finished with polishing paste
Primary Outcome Measure Information:
Title
Change in serum level of C-reactive protein
Description
Change in serum level of C-reactive protein 24 hours following the full mouth debridement
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Treatment time
Description
Evaluate the effect of treatment time (minute) on clinical parameters after 30 days
Time Frame
30 days
Title
Change in percentage of bleeding on probing
Description
Change in the percentage of bleeding on probing 30 days after treatment
Time Frame
30 days
Title
Change in mean probing pocket depth
Description
Change in mean probing pocket depth (mm) 30 days after treatment
Time Frame
30 days
Title
Change in clinical attachment loss
Description
Change in clinical attachment loss (mm)30 days after treatment
Time Frame
30 days
Title
Change in percentage of plaque index
Description
Change in percentage of plaque index 30 days after treatment
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammed K Ayoob
Organizational Affiliation
University of Baghdad
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mohammed Kalid Ayoob
City
Baghdad
ZIP/Postal Code
10053
Country
Iraq

12. IPD Sharing Statement

Plan to Share IPD
No

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

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