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Effects of Nd:YAG Laser and Air Abrasive Combined Application in Patients With Periodontitis

Primary Purpose

Periodontitis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Air Abrasive
Nd:YAG Laser
Non surgical periodontal therapy
Sponsored by
Izmir Katip Celebi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis focused on measuring Periodontitis, Non surgical periodontal treatment, Nd:YAG laser, Perioflow, Erythritol Powder

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Systemically healthy (The determination of healthy volunteers will be based on the statements of the patients in the anamnesis. No additional examinations will be made.),
  • Having a total of at least twenty permanent teeth in the mouth,
  • Non-smoker
  • Have not used antibiotics, anti-inflammatory and systemic corticosteroid drugs in the last 6 months,
  • Not in pregnancy or lactation period,
  • Patients who have not received periodontal treatment in the last 6 months,
  • Patients who accepted the research and signed the informed volunteer consent form
  • Bleeding on probing in 30% or more areas,
  • 5 mm or more probing pocket depth in each quadrant in at least 2 non-adjacent teeth
  • 4mm or more attachment loss,
  • Coronal 1/3 or more (horizontal and/or vertical) on radiograph individuals with bone loss were included

Exclusion Criteria:

  • Having any systemic disease,
  • Regularly using a systemic medication,
  • Being pregnant or lactating.
  • To have had periodontal treatment in the last 6 months.
  • Receiving antibiotic, anti-inflammatory or systemic corticosteroid medication in the last 6 months.
  • Smoking.

Sites / Locations

  • Izmir Katip Celebi University Faculty of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control

Test

Arm Description

Only non surgical periodontal treatment

Nd:YAG Laser and air abrasive combined application addition to non surgical periodontal treatment

Outcomes

Primary Outcome Measures

Clinical attachment level change
With the help of a Williams periodontal probe, the distance between the enamel-cementum border and the sulcus/pocket floor will be measured from the six points of the tooth: mesiobuccal, midbuccal, distobuccal, mesiopalatal/lingual, mid-buccal/palatal and distobuccal/palatal.

Secondary Outcome Measures

Full Information

First Posted
October 7, 2021
Last Updated
October 19, 2021
Sponsor
Izmir Katip Celebi University
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1. Study Identification

Unique Protocol Identification Number
NCT05101603
Brief Title
Effects of Nd:YAG Laser and Air Abrasive Combined Application in Patients With Periodontitis
Official Title
Effects of Nd:YAG Laser and Air Abrasive Combined Application on Clinical Parameters in Addition to Non Surgical Periodontal Treatment in Patients With Periodontitis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
September 1, 2020 (Actual)
Study Completion Date
September 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Izmir Katip Celebi University

4. Oversight

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

5. Study Description

Brief Summary
The aim of this clinical study is to investigate the effectiveness of the combined application of Nd:YAG (neodymium-doped yttrium aluminum garnet) laser and air abrasive applied in addition to nonsurgical periodontal treatment on clinical parameters in patients with periodontitis. A split-mouth, randomized study included 24 systemically healthy, non-smoker, periodontitis patients. In addition to non-surgical periodontal treatment, air abrasive (erythritol-chlorhexidine powder) and Nd:YAG laser (2 W, 200mJ, 10 Hz) combined application was applied to the test group, while only non-surgical periodontal treatment was applied to the control group. Clinical periodontal records of the patients, including plaque index (PI), gingival index (GI), bleeding on probing (BOP), probing pocket depth (PD), clinical attachment level (CAL), were taken before the treatment and at the 1st and 3rd months after the treatment. All clinical parameters improved significantly from baseline for both groups after treatment (p˂0.05). In the evaluation between the test and control groups, no statistically significant difference was found in the PI, GI and BOP parameters of the patients at any time (p˃0.05). While the amount of change in PD and CAL values after treatment in medium deep pockets in the study groups was compared, no significant difference was observed between the groups (p˃0.05), statistically significant improvements in PD and CAL parameters were observed in the test group compared to the control group only for deep pockets (≥7 mm) among the groups (p˂0.05).In conclusion, it has been observed that the combined application of Nd:YAG laser and air abrasive in systemically healthy, stage III and grade C periodontitis patients is in the short term on PD and CAL, especially in inaccessible areas such as deep pockets.
Detailed Description
Recently, erythritol has been introduced as a new air abrasive powder. Erythritol is a sugar alcohol. It is a water-soluble, chemically neutral artificial sweetener. Compared to glycine, another powder used in air abrasive devices, erythritol has a smaller particle size. Subgingival air abrasive application with erythritol has been shown to effectively remove subgingival biofilm from the root surface. In addition, erythritol has been reported to suppress bi-species biofilm formation of Porphyromonas gingivalis (p. gingivalis) and Streptococcus gordonii (s. gordonii) through ribonucleic acid (RNA) and deoxyribonucleic acid (DNA) depletion and metabolic changes. In recent years, lasers have gained increasing interest in the treatment of periodontitis as an adjunct or alternative treatment procedure to conventional treatment. It has been stated that the Nd:YAG laser provides excellent tissue ablation with strong bactericidal and detoxification effects, and it has been shown that it can reach deep pockets that conventional instruments cannot reach (7,19). It has been reported that Nd:YAG laser creates a very thick coagulation layer on soft tissue surfaces. It has also been proven that when applied to the pockets, it can remove the infected pocket epithelium. When applied in addition to non-surgical periodontal therapy, it has been shown to dramatically improve the clinical manifestations of periodontal inflammation compared to conventional therapy. In this clinical study, it was aimed to clinically evaluate the effectiveness of subgingival Nd:YAG laser and air abrasive combined application in addition to non-surgical periodontal treatment in systemically healthy periodontitis patients. The efficacy of the combined Nd:YAG laser and air abrasive application was evaluated by examining the clinical periodontal parameters of the patients [plaque index (PI), probing pocket depth (PD), gingival index (GI), probing bleeding index (BI) and clinical attachment level (CAL)]. It is thought that, in addition to non-surgical periodontal treatment, YAG laser and air abrasive combined applications will have an antimicrobial effect on the biofilm in difficult areas and deep pockets that hand tools cannot reach, provide better penetration than irrigation fluids and contribute to periodontal regeneration. Thus, it is hoped to increase clinical success, prevent disease recurrences, reduce the need for periodontal surgery and increase the quality of life of patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis
Keywords
Periodontitis, Non surgical periodontal treatment, Nd:YAG laser, Perioflow, Erythritol Powder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Description
Only non surgical periodontal treatment
Arm Title
Test
Arm Type
Experimental
Arm Description
Nd:YAG Laser and air abrasive combined application addition to non surgical periodontal treatment
Intervention Type
Device
Intervention Name(s)
Air Abrasive
Other Intervention Name(s)
EMS Dental Air-Flow® Handy Perio, Switzerland
Intervention Description
Applied with Nd:YAG Laser on periodontal pockets
Intervention Type
Device
Intervention Name(s)
Nd:YAG Laser
Other Intervention Name(s)
Fotona Fidelis AT, Ljubljana, SLOVENIA
Intervention Description
Applied with Air Abrasive on periodontal pockets
Intervention Type
Procedure
Intervention Name(s)
Non surgical periodontal therapy
Intervention Description
The first phase, in which optimum plaque control is achieved and local etiological factors are removed, is the first step of all periodontal diseases and surgical procedures.
Primary Outcome Measure Information:
Title
Clinical attachment level change
Description
With the help of a Williams periodontal probe, the distance between the enamel-cementum border and the sulcus/pocket floor will be measured from the six points of the tooth: mesiobuccal, midbuccal, distobuccal, mesiopalatal/lingual, mid-buccal/palatal and distobuccal/palatal.
Time Frame
Change from baseline clinical attachment level at 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Systemically healthy (The determination of healthy volunteers will be based on the statements of the patients in the anamnesis. No additional examinations will be made.), Having a total of at least twenty permanent teeth in the mouth, Non-smoker Have not used antibiotics, anti-inflammatory and systemic corticosteroid drugs in the last 6 months, Not in pregnancy or lactation period, Patients who have not received periodontal treatment in the last 6 months, Patients who accepted the research and signed the informed volunteer consent form Bleeding on probing in 30% or more areas, 5 mm or more probing pocket depth in each quadrant in at least 2 non-adjacent teeth 4mm or more attachment loss, Coronal 1/3 or more (horizontal and/or vertical) on radiograph individuals with bone loss were included Exclusion Criteria: Having any systemic disease, Regularly using a systemic medication, Being pregnant or lactating. To have had periodontal treatment in the last 6 months. Receiving antibiotic, anti-inflammatory or systemic corticosteroid medication in the last 6 months. Smoking.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mehmet Sağlam
Organizational Affiliation
Izmir Katip Celebi University Faculty of Dentistry
Official's Role
Study Director
Facility Information:
Facility Name
Izmir Katip Celebi University Faculty of Dentistry
City
İzmir
State/Province
Çiğli
ZIP/Postal Code
35000
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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24078975
Citation
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Effects of Nd:YAG Laser and Air Abrasive Combined Application in Patients With Periodontitis

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