YSGG Application in Periodontal Treatment

NCT05588544 | Completed

• 1 other identifier: 2019AN0551
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change of Modified gingival index

  Level of gingival inflammation

  1, 2, 4, and 8 week post-operatively

Study Arms (2)

SRP only

ACTIVE COMPARATOR

Periodontal treatment by scaling and root planning

Procedure: Er,Cr:YSGG laser

SRP + laser

EXPERIMENTAL

Periodontal treatment by Laser-assisted scaling and root planning

Procedure: Er,Cr:YSGG laser

Interventions

Er,Cr:YSGG laser PROCEDURE

Use of laser at the degranulation step of the treatment

SRP + laser; SRP only

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of stage III or IV periodontitis based on the 2017 periodontitis classification (Tonetti, Greenwell, \& Kornman, 2018);
• minimum of two teeth with probing depth (PD) ≥ 6 mm and radiographic bone loss in at least two quadrants of the whole dentition;
• each quadrant with a minimum of four teeth; and
• systemically healthy patients.

You may not qualify if:

• history of periodontal treatment in the previous six months;
• antibiotic medication in recent three months;
• under steroid therapy or taking any anti-inflammatory drugs in recent three months;
• 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;
• pregnancy or breastfeeding; and
• smoking habits.

Sponsors & Collaborators

• Korea University Anam Hospital: lead

Study Sites (1)

Korea University Anam Hospital

Seoul, 02841, South Korea

Location

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Officials

• Jung Soo Park

  Korea University Anam Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical assistant professor

Study Record Dates

• First Submitted: October 11, 2022
• First Posted: October 20, 2022
• Study Start: May 26, 2020
• Primary Completion: June 29, 2021
• Study Completion: June 29, 2021
• Last Updated: October 20, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)