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YSGG Application in Periodontal Treatment

Primary Purpose

Periodontal Diseases

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Er,Cr:YSGG laser
Sponsored by
Korea University Anam Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontal Diseases

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Korea University Anam Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

SRP only

SRP + laser

Arm Description

Periodontal treatment by scaling and root planning

Periodontal treatment by Laser-assisted scaling and root planning

Outcomes

Primary Outcome Measures

Change of Modified gingival index
Level of gingival inflammation

Secondary Outcome Measures

Full Information

First Posted
October 11, 2022
Last Updated
October 18, 2022
Sponsor
Korea University Anam Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05588544
Brief Title
YSGG Application in Periodontal Treatment
Official Title
Effect of Adjunctive YSGG Application in Healing Following Periodontal Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
May 26, 2020 (Actual)
Primary Completion Date
June 29, 2021 (Actual)
Study Completion Date
June 29, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Korea University Anam Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SRP only
Arm Type
Active Comparator
Arm Description
Periodontal treatment by scaling and root planning
Arm Title
SRP + laser
Arm Type
Experimental
Arm Description
Periodontal treatment by Laser-assisted scaling and root planning
Intervention Type
Procedure
Intervention Name(s)
Er,Cr:YSGG laser
Intervention Description
Use of laser at the degranulation step of the treatment
Primary Outcome Measure Information:
Title
Change of Modified gingival index
Description
Level of gingival inflammation
Time Frame
1, 2, 4, and 8 week post-operatively

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jung Soo Park
Organizational Affiliation
Korea University Anam Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Korea University Anam Hospital
City
Seoul
ZIP/Postal Code
02841
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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YSGG Application in Periodontal Treatment

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