Efficacy of Subgingival Erythritol Air Polishing in Treatment of Periodontal Pockets

NCT ID: NCT05798871

Last Updated: 2023-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-05

Study Completion Date

2024-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Periodontal Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Subgingival erythritol air polishing

The treatment will include the following therapy steps:

1. Supragingival debridement.
2. Subgingival erythritol air polishing by perioflow.

Group Type ACTIVE_COMPARATOR

Subgingival erythritol air polishing

Intervention Type PROCEDURE

The intervention will start with supragingival debridement followed by subgingival erythritol air polishing by perioflow.

subgingival debridement

Conventional root planing

The treatment will include the following therapy steps:

1. Supragingival debridement.
2. Subgingival root planing by curette.

Group Type ACTIVE_COMPARATOR

Conventional root planing

Intervention Type PROCEDURE

The intervention will start with supragingival debridement followed by root planing by curette.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Subgingival erythritol air polishing

The intervention will start with supragingival debridement followed by subgingival erythritol air polishing by perioflow.

subgingival debridement

Intervention Type PROCEDURE

Conventional root planing

The intervention will start with supragingival debridement followed by root planing by curette.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Baghdad

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Hayder Raad Abdulbaqi

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mohsen K Abbass

Role: PRINCIPAL_INVESTIGATOR

University of Baghdad

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hayder R Abdulbaqi

Baghdad, , Iraq

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Iraq

References

Explore related publications, articles, or registry entries linked to this study.

Aljaberi M, Abdulbaqi HR. Efficacy of Erythritol Air Polishing for Inducing Initial Healing of Shallow-to-Moderate Periodontal Pockets and Restoring Gingival Crevicular Fluid beta-Catenin, 8-Hydroxy-Deoxyguanosine and Total Antioxidant Capacity: A Split-Mouth Randomised Clinical Trial. Int J Dent Hyg. 2025 Aug;23(3):559-569. doi: 10.1111/idh.12887. Epub 2024 Dec 17.

Reference Type DERIVED
PMID: 39686830 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

746622

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.