Er:YAG Laser and Air Polishing Application in Periodontal Treatment

NCT06574802 | Recruiting DMC

• 1 other identifier: CYFH202207
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Periodontitis (gum disease) is an infection of the gums that can lead to tooth loss. In recent years, many types of dental lasers or other devices have been used for the non-surgical treatment of periodontal diseases. However, it remains unclear whether the combined application of laser and air polishing is effective as an adjuvant treatment for periodontitis. The purpose of this study is to compare the use of combined application of Er:YAG laser and sub-gingival air polishing powder, with the treatment of Er:YAG laser only, in periodontal diseases treatment in a Chinese population.

Conditions

Periodontitis

Keywords

generalized, stage Ⅱ or stage Ⅲ

Outcome Measures

Primary Outcomes (2)

• Changes in PD

  Changes in probing depth (PD) measured using periodontal probing

  at 3 months, 6 months, 1 year, and 2 years

• Changes in CAL

  Changes in clinical attachment level (CAL) measured using periodontal probing

  at 3 months, 6 months, 1 year, and 2 years

Secondary Outcomes (2)

• changes in BI

  at 3 months, 6 months, 1 year, and 2 years

• PLI

  at 3 months, 6 months, 1 year, and 2 years

Study Arms (2)

test group

ACTIVE COMPARATOR

Er:YAG laser (ERL) plus sub-gingival air polishing treatment

Procedure: ERL + air polishing

control group

PLACEBO COMPARATOR

ERL treatment only

Procedure: ERL

Interventions

ERL + air polishing PROCEDURE

Er:YAG laser (ERL) plus sub-gingival air polishing treatment

test group

ERL PROCEDURE

ERL treatment

control group

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) aged 35-65 years old, in good systemic healthy;
• \) clinically diagnosed with generalized stage Ⅱ or stage Ⅲ periodontitis;
• \) a minimum of 20 teeth

You may not qualify if:

• \) pregnancy or recent pregnancy plans;
• \) had received periodontal treatment within the previous 6 months;
• \) taken antibiotics within the previous 3 months;
• \) had diabetes;
• \) obvious malocclusion, history of orthodontic treatment, or a habit of mouth breathing.

Sponsors & Collaborators

• Beijing Chao Yang Hospital: lead

Study Sites (1)

Beijing Chao Yang Hospital

Beijing, Beijing Municipality, 100020, China

RECRUITING

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• GuangXu Liu, Doctor

  Research Department

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xuan Zhou, Doctor

CONTACT

86-10-85231344; xuanzhou@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: August 28, 2024
• Study Start: September 4, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 7, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)