YSGG Application in Periodontal Treatment

Sponsor
Korea University Anam Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05588544
Collaborator
(none)
12
1
2
13.1
0.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Er,Cr:YSGG laser
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effect of Adjunctive YSGG Application in Healing Following Periodontal Treatment
Actual Study Start Date :
May 26, 2020
Actual Primary Completion Date :
Jun 29, 2021
Actual Study Completion Date :
Jun 29, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: SRP only

Periodontal treatment by scaling and root planning

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

Experimental: SRP + laser

Periodontal treatment by Laser-assisted scaling and root planning

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

Outcome Measures

Primary Outcome Measures

  1. Change of Modified gingival index [1, 2, 4, and 8 week post-operatively]

    Level of gingival inflammation

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Korea University Anam Hospital Seoul Korea, Republic of 02841

Sponsors and Collaborators

  • Korea University Anam Hospital

Investigators

  • Principal Investigator: Jung Soo Park, Korea University Anam Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Park, Jung Soo, Clinical assistant professor, Korea University Anam Hospital
ClinicalTrials.gov Identifier:
NCT05588544
Other Study ID Numbers:
  • 2019AN0551
First Posted:
Oct 20, 2022
Last Update Posted:
Oct 20, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 20, 2022