Efficacy of Subgingival Erythritol Air Polishing in Treatment of Periodontal Pockets

Periodontal Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05798871
• Other study ID #: 746622
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 5, 2023
• Est. completion date: September 2024

Study information

• Verified date: April 2023
• Source: University of Baghdad
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 25
• Est. completion date: September 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Periodontal Diseases
• Periodontal Pocket

Intervention

Procedure:
• Subgingival erythritol air polishing
The intervention will start with supragingival debridement followed by subgingival erythritol air polishing by perioflow. subgingival debridement
• Conventional root planing
The intervention will start with supragingival debridement followed by root planing by curette.

Locations

Country	Name	City	State
Iraq	Hayder R Abdulbaqi	Baghdad

Sponsors (1)

Lead Sponsor	Collaborator
University of Baghdad

Country where clinical trial is conducted

Iraq, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pocket depth	Change of pocket depth (in mm) one month after treatment	1 month
Secondary	Clinical attachment loss	Change of clinical attachment loss (in mm) one month after treatment.	1 month
Secondary	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
Secondary	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
Secondary	Plaque index	Change in plaque index percentage one month after treatment	1 month
Secondary	Bleeding on probing	Change in bleeding on p[robing percentage one month after treatment	1 month