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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05588544
Other study ID # 2019AN0551
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 26, 2020
Est. completion date June 29, 2021

Study information

Verified date October 2022
Source Korea University Anam Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date June 29, 2021
Est. primary completion date June 29, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Er,Cr:YSGG laser
Use of laser at the degranulation step of the treatment

Locations

Country Name City State
Korea, Republic of Korea University Anam Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Korea University Anam Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change of Modified gingival index Level of gingival inflammation 1, 2, 4, and 8 week post-operatively
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