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Efficacy of Subgingival Erythritol Air Polishing in Treatment of Periodontal Pockets

Primary Purpose

Periodontal Diseases

Status
Active
Phase
Not Applicable
Locations
Iraq
Study Type
Interventional
Intervention
Subgingival erythritol air polishing
Conventional root planing
Sponsored by
University of Baghdad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontal Diseases focused on measuring Periodontal Disease, Air-Polishing, Air Abrasion, Periodontitis, Tooth Polishing, periodontal pockets

Eligibility Criteria

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

Inclusion Criteria: Participants should be medically healthy with periodontitis. Participants should have generalized periodontitis with pockets of PPD = 4 to 6 mm of any stage, unstable, and grade A to C. Only teeth with single root will be included. Exclusion Criteria: Participants who have active cavity caries, endodontic treatment. Participants who have ongoing orthodontic treatment. Participants who have been on antibiotics within the past 4 months. Participants who require prophylactic antibiotic coverage. Participants who have been on systemic or topical non-steroidal anti- inflammatory drugs for the past 4 months. Participants who are pregnant or intended to and lactating mother. Participants who have heart valve replacement and have known intolerance or allergy to mouth rinses. Participants who have any systemic disease and smokers.

Sites / Locations

  • Hayder R Abdulbaqi

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Subgingival erythritol air polishing

Conventional root planing

Arm Description

The treatment will include the following therapy steps: Supragingival debridement. Subgingival erythritol air polishing by perioflow.

The treatment will include the following therapy steps: Supragingival debridement. Subgingival root planing by curette.

Outcomes

Primary Outcome Measures

Pocket depth
Change of pocket depth (in mm) one month after treatment

Secondary Outcome Measures

Clinical attachment loss
Change of clinical attachment loss (in mm) one month after treatment.
Mean relative changes in beta catenin levels in gingival crevicular fluid.
Mean relative changes in beta catenin levels in gingival crevicular fluid one month after treatment.
Mean relative changes in 8-hydroxy-deoxyguanosine (8-OHdG) levels in gingival crevicular fluid
Mean relative changes in 8-hydroxy-deoxyguanosine (8-OHdG) levels in gingival crevicular fluid one month after treatment
Plaque index
Change in plaque index percentage one month after treatment
Bleeding on probing
Change in bleeding on p[robing percentage one month after treatment

Full Information

First Posted
March 19, 2023
Last Updated
April 2, 2023
Sponsor
University of Baghdad
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1. Study Identification

Unique Protocol Identification Number
NCT05798871
Brief Title
Efficacy of Subgingival Erythritol Air Polishing in Treatment of Periodontal Pockets
Official Title
Impact of Erythritol Air-polishing as a Sole Treatment in the Initial Healing of Shallow Periodontal Pockets
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 5, 2023 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
September 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 is an inflammation associated with destruction of the periodontium that ultimately, if not treated, leads to tooth loss. Clinically, it is characterized by clinical attachment loss (CAL) and bleeding on probing (BOP) accompanied by increased probing pocket depth (PPD) and/or gingival recession. The standard periodontitis treatment aims to restore the homeostasis of the immune system by mechanically reducing the microbial load to levels that are compatible with stability and health. This is achieved by professional mechanical biofilm control and motivation of the patient for oral hygiene measures in order to control the biofilm and avoid disease recurrence. Conventional scaling and root planing (SRP), and air polishing therapy are tools used for professional biofilm control. More recently, air-polishing devices have become a promising alternative to conventional SRP in reducing the clinical time and causing less discomfort and pain for the patients. The objective of this study is to evaluate the efficacy of subgingival erythritol air polishing for initial periodontal pocket healing.
Detailed Description
Periodontitis results from a polymicrobial dysbiosis with keystone pathogens affecting the virulence of the entire biofilm community. Thus, the inability of the host immune system to eliminate the biofilm insult leads to a complex chronic response with the destruction of bone and periodontal ligament attachment. The main goal of periodontal therapy is to arrest further attachment loss and, consequently, prevent further disease progression and subsequent tooth loss. In most cases, this goal can be predictably achieved by means of non-surgical periodontal therapy using hand, ultrasonic instruments and air polishing devices. Treatment with scaling and root planing often results in an additional increase of root hypersensitivity, thus impairing the patient's quality of life. Minimally invasive periodontal therapy primarily focus on calculus removal and effective removal of the biofilm rather than on excessive and intentional removal of root cementum. Air polishing with erythritol powder seems more effective than manual instrumentation at disrupting biofilm in both shallow and deep pockets, whilst it is more gentle on the root surface and soft tissues, and allowing proper attachment of periodontal ligament fibroblasts. Erythritol powder air-polishing with ultrasonic debridement has reported to need less time than ultrasonic debridement with polishing during periodontal therapy.Therefore, this study will evaluate the impact of erythritol air polishing in resolving periodontal pockets.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Diseases
Keywords
Periodontal Disease, Air-Polishing, Air Abrasion, Periodontitis, Tooth Polishing, periodontal pockets

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Subgingival erythritol air polishing
Arm Type
Active Comparator
Arm Description
The treatment will include the following therapy steps: Supragingival debridement. Subgingival erythritol air polishing by perioflow.
Arm Title
Conventional root planing
Arm Type
Active Comparator
Arm Description
The treatment will include the following therapy steps: Supragingival debridement. Subgingival root planing by curette.
Intervention Type
Procedure
Intervention Name(s)
Subgingival erythritol air polishing
Intervention Description
The intervention will start with supragingival debridement followed by subgingival erythritol air polishing by perioflow. subgingival debridement
Intervention Type
Procedure
Intervention Name(s)
Conventional root planing
Intervention Description
The intervention will start with supragingival debridement followed by root planing by curette.
Primary Outcome Measure Information:
Title
Pocket depth
Description
Change of pocket depth (in mm) one month after treatment
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Clinical attachment loss
Description
Change of clinical attachment loss (in mm) one month after treatment.
Time Frame
1 month
Title
Mean relative changes in beta catenin levels in gingival crevicular fluid.
Description
Mean relative changes in beta catenin levels in gingival crevicular fluid one month after treatment.
Time Frame
1 month
Title
Mean relative changes in 8-hydroxy-deoxyguanosine (8-OHdG) levels in gingival crevicular fluid
Description
Mean relative changes in 8-hydroxy-deoxyguanosine (8-OHdG) levels in gingival crevicular fluid one month after treatment
Time Frame
1 month
Title
Plaque index
Description
Change in plaque index percentage one month after treatment
Time Frame
1 month
Title
Bleeding on probing
Description
Change in bleeding on p[robing percentage one month after treatment
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Participants should be medically healthy with periodontitis. Participants should have generalized periodontitis with pockets of PPD = 4 to 6 mm of any stage, unstable, and grade A to C. Only teeth with single root will be included. Exclusion Criteria: Participants who have active cavity caries, endodontic treatment. Participants who have ongoing orthodontic treatment. Participants who have been on antibiotics within the past 4 months. Participants who require prophylactic antibiotic coverage. Participants who have been on systemic or topical non-steroidal anti- inflammatory drugs for the past 4 months. Participants who are pregnant or intended to and lactating mother. Participants who have heart valve replacement and have known intolerance or allergy to mouth rinses. Participants who have any systemic disease and smokers.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohsen K Abbass
Organizational Affiliation
University of Baghdad
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hayder R Abdulbaqi
City
Baghdad
ZIP/Postal Code
10011
Country
Iraq

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Efficacy of Subgingival Erythritol Air Polishing in Treatment of Periodontal Pockets

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