YSGG Application in Periodontal Treatment

NCT ID: NCT05588544

Last Updated: 2022-10-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-26
• Study Completion Date: 2021-06-29

Brief Summary

Adjunctive use of Er,Cr:YSGG (erbium-chromium-yttrium-scandium-gallium-garnet) laser in combination with conventional, mechanical periodontal treatment may benefit in complete decontamination of the periodontal pocket leading to improved early healing and better long term clinical result. Radial firing periodontal tip (RFPT) offered by the Er,Cr:YSGG system is devised to let irradiation primarily in radial pattern (85%) with lesser portion in straight manner (15%), meaning laser beams are effectively emitted to affected root surface and inner epithelium of periodontal pocket with simple tip management. Therefore, using Er,Cr:YSGG laser with RFPT could be the best option for periodontal laser therapy. The aim of this study is to investigate adjunctive treatment effect using Er,Cr:YSGG laser and RFPT in moderate to severe periodontitis patients. Study subjects are randomly allocated to either 'scaling and root planing (SRP) only' or 'SRP + laser therapy' group. Periodontal parameters including probing pocket depth (PPD), clinical attachment level (CAL), modified gingival index (MGI), and plaque index (PI) are recorded at baseline and 8 weeks after treatment. Gingival crevicular fluid (GCF) samples are obtained using paper strips at baseline, 1w, 2w, 4w, and 8w post op. to determine laser-induced effect in early wound healing. Cytokine levels are evaluated from the GCF samples taken.

Conditions

Periodontal Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

SRP only

Periodontal treatment by scaling and root planning

Group Type: ACTIVE_COMPARATOR

Er,Cr:YSGG laser

Intervention Type: PROCEDURE

Use of laser at the degranulation step of the treatment

SRP + laser

Periodontal treatment by Laser-assisted scaling and root planning

Group Type: EXPERIMENTAL

Er,Cr:YSGG laser

Intervention Type: PROCEDURE

Use of laser at the degranulation step of the treatment

Interventions

Er,Cr:YSGG laser

Use of laser at the degranulation step of the treatment

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. diagnosis of stage III or IV periodontitis based on the 2017 periodontitis classification (Tonetti, Greenwell, & Kornman, 2018);

2. minimum of two teeth with probing depth (PD) ≥ 6 mm and radiographic bone loss in at least two quadrants of the whole dentition;

3. each quadrant with a minimum of four teeth; and

4. systemically healthy patients.

Exclusion Criteria

1. history of periodontal treatment in the previous six months;

2. antibiotic medication in recent three months;

3. under steroid therapy or taking any anti-inflammatory drugs in recent three months;

4. history of any systemic disease that may influence the periodontal condition and treatment outcome, including diabetes mellitus, cancer, metabolic diseases, cardiovascular disease, and rheumatoid arthritis;

5. pregnancy or breastfeeding; and

6. smoking habits.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Korea University Anam Hospital

OTHER

Sponsor Role: lead

Responsible Party

Park, Jung Soo

Clinical assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jung Soo Park

Role: PRINCIPAL_INVESTIGATOR

Korea University Anam Hospital

Locations

Korea University Anam Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

2019AN0551

Identifier Type: -

Identifier Source: org_study_id