NCT06209554

Brief Summary

The present study aims to evaluate the efficacy of subgingival air polishing by erythritol and diode laser in the treatment of periodontitis (clinically and microbiologically).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 13, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 17, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 8, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 17, 2024

Completed
Last Updated

January 23, 2024

Status Verified

January 1, 2024

Enrollment Period

2 months

First QC Date

January 8, 2024

Last Update Submit

January 21, 2024

Conditions

Keywords

Diode laser, Erythritol

Outcome Measures

Primary Outcomes (1)

  • probing depth and clinical attachment loss

    decreasing probing depth and clinical attachment loss refer to healing of periodontal pocket

    baseline and 6 weeks follow up

Study Arms (3)

control group

EXPERIMENTAL

Eight patients to be treated with only Scaling and root planning .

Device: ultrasonic tips and Gracey curettes, airflow with erythritol and diode laser

erythritol group

EXPERIMENTAL

Eight patients to be treated with erythritol air polishing as an adjunct to Scaling and root planning .

Device: ultrasonic tips and Gracey curettes, airflow with erythritol and diode laser

laser group

EXPERIMENTAL

Eight patients to be treated with dioad laser as an adjunct to Scaling and root planning .

Device: ultrasonic tips and Gracey curettes, airflow with erythritol and diode laser

Interventions

diode laser and erythritol used as adjunctive method in the treatment of periodontitis in addition to scaling and root planning

control grouperythritol grouplaser group

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Systemically healthy patients. Patient with stageІ\& stage ІІ periodontitis according to Classification of periodontal and peri-implant diseases and conditions 2017

You may not qualify if:

  • Patients with any systemic disease linked to delayed wound healing, such as uncontrolled diabetes, autoimmune diseases, heart conditions, etc.
  • Current smokers. Patients underwent prior periodontal therapy within the last 6 months. Individuals who had used antibiotics in the previous 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura Univeristy

Al Mansurah, Egypt

Location

Related Publications (1)

  • Elmeligy SMA, Saleh W, Elewa GM, Abu El-Ezz HZ, Mahmoud NM, Elmeadawy S. The efficacy of diode laser and subgingival air polishing with erythritol in treatment of periodontitis (clinical and microbiological study). BMC Oral Health. 2024 Jul 4;24(1):763. doi: 10.1186/s12903-024-04481-6.

MeSH Terms

Conditions

Periodontitis

Interventions

Lasers, Semiconductor

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

LasersOptical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Study Officials

  • samah H elmeadawy, ph.D

    Mansoura U

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Investigator Affiliation

Study Record Dates

First Submitted

January 8, 2024

First Posted

January 17, 2024

Study Start

January 13, 2023

Primary Completion

March 1, 2023

Study Completion

March 17, 2023

Last Updated

January 23, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

it is difficult to be in direct contact with patient after work is finished ,due to the distance.

Locations