Efficacy of Subgingival Erythritol Air Polishing in Treatment of Periodontal Pockets

Impact of Erythritol Air-polishing as a Sole Treatment in the Initial Healing of Shallow Periodontal Pockets

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Periodontal Diseases
• Intervention / Treatment: Procedure: Subgingival erythritol air polishing; Procedure: Conventional root planing

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.

• Study Type: Interventional
• Enrollment (Anticipated): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iraq
  • Baghdad, Iraq, 10011
    • Hayder R Abdulbaqi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Subgingival erythritol air polishing; The treatment will include the following therapy steps: Supragingival debridement.; Subgingival erythritol air polishing by perioflow.	Procedure: Subgingival erythritol air polishing; The intervention will start with supragingival debridement followed by subgingival erythritol air polishing by perioflow. subgingival debridement
Active Comparator: Conventional root planing; The treatment will include the following therapy steps: Supragingival debridement.; Subgingival root planing by curette.	Procedure: Conventional root planing; The intervention will start with supragingival debridement followed by root planing by curette.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pocket depth	Change of pocket depth (in mm) one month after treatment	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical attachment loss	Change of clinical attachment loss (in mm) one month after treatment.	1 month
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.	1 month
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	1 month
Plaque index	Change in plaque index percentage one month after treatment	1 month
Bleeding on probing	Change in bleeding on p[robing percentage one month after treatment	1 month

Collaborators and Investigators

• Sponsor: University of Baghdad
• Investigators: Principal Investigator: Mohsen K Abbass, University of Baghdad

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2023
• Primary Completion (Anticipated): March 1, 2024
• Study Completion (Anticipated): September 1, 2024

Study Registration Dates

• First Submitted: March 19, 2023
• First Submitted That Met QC Criteria: April 2, 2023
• First Posted (Actual): April 5, 2023

Study Record Updates

• Last Update Posted (Actual): April 5, 2023
• Last Update Submitted That Met QC Criteria: April 2, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Periodontitis; Periodontal Disease; periodontal pockets; Air-Polishing; Air Abrasion; Tooth Polishing
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Periodontitis; Periodontal Diseases; Periodontal Pocket; Vasodilator Agents; Erythritol
• Other Study ID Numbers: 746622

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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