Efficacy of Subgingival Erythritol Air Polishing in Treatment of Periodontal Pockets

NCT05798871 | Unknown

• 1 other identifier: 746622
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontal Diseases

Keywords

Periodontal Disease; Air-Polishing; Air Abrasion; Periodontitis; Tooth Polishing; periodontal pockets

Outcome Measures

Primary Outcomes (1)

• Pocket depth

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

  1 month

Secondary Outcomes (5)

• Clinical attachment loss

  1 month

• Mean relative changes in beta catenin levels in gingival crevicular fluid.

  1 month

• Mean relative changes in 8-hydroxy-deoxyguanosine (8-OHdG) levels in gingival crevicular fluid

  1 month

• Plaque index

  1 month

• Bleeding on probing

  1 month

Study Arms (2)

Subgingival erythritol air polishing

ACTIVE COMPARATOR

The treatment will include the following therapy steps: 1. Supragingival debridement. 2. Subgingival erythritol air polishing by perioflow.

Procedure: Subgingival erythritol air polishing

Conventional root planing

ACTIVE COMPARATOR

The treatment will include the following therapy steps: 1. Supragingival debridement. 2. Subgingival root planing by curette.

Procedure: Conventional root planing

Interventions

Subgingival erythritol air polishing PROCEDURE

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

Subgingival erythritol air polishing

Conventional root planing PROCEDURE

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

Conventional root planing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Baghdad: lead

Study Sites (1)

Hayder R Abdulbaqi

Baghdad, 10011, Iraq

Location

Related Publications (1)

• 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.

  PMID: 39686830 DERIVED

MeSH Terms

Conditions

Periodontal Diseases; Periodontitis; Periodontal Pocket

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Officials

• Mohsen K Abbass

  University of Baghdad

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: March 19, 2023
• First Posted: April 5, 2023
• Study Start: March 5, 2023
• Primary Completion: March 1, 2024
• Study Completion: September 1, 2024
• Last Updated: April 5, 2023

Record last verified: 2023-04

Locations

IR (1)