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Diode Laser Application With Non-Surgical Periodontal Treatment

Primary Purpose

Periodontitis

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
diode laser
scaling - root planning
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis focused on measuring periodontitis, Gingival crevicular fluid, diode laser, sclerostin, TWEAK

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Presence of 5mm or more periodontal pockets on one or more surfaces in periodontal tissues,
  2. Not having periodontal treatment in the last 3 months,
  3. The informed consent form must be approved,
  4. At least 18 years old.

Exclusion Criteria:

  1. Presence of systemic disease,
  2. Smoking,
  3. Regular use of non-steroidal anti inflammatory drugs,
  4. Having been treated with antibiotics in the last 3 months,
  5. Individuals in need of pre-treatment antibiotic prophylaxis,
  6. Pregnancy and lactation,
  7. Not approving the informed consent form,
  8. Patients with known allergies.

Sites / Locations

  • Hacettepe Universty

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Laser group

Control group

Arm Description

Root-planning was performed using Gracey curettes in the areas where periodontal pockets were diagnosed after scaling. Laser application was then applied to the areas where root planning was applied. Laser was applied in continuous phase at 0.80W power, 940 nm wavelength and 0.80 J / s energy level.

Root-planning was performed using Gracey curettes in the areas where periodontal pockets were diagnosed after scaling.

Outcomes

Primary Outcome Measures

The primary outcome of the study was the control examination performed 3 months after the first examination. At the 3rd month control, the same researcher measured clinical parameters from all patients
Probing depth is the measurement from the free gingival margin, to the base of the pocket in millimeters of the distance. Periodontal probe is used.

Secondary Outcome Measures

The secondary outcome of the study is the recording of bleeding index in the 3rd month.
The bleeding index is evaluated as positive if there is bleeding in the gingiva during probing.
Another outcome of the study is the collection of gingival crevicular fluid samples in the 3rd month.
Samples are obtained by means of paper strips placed gently in the gingival groove. These samples are stored at -20 ° C for later analysis by ELISA method.
The secondary outcome of the study is a measure of the clinical attachment level.
The distance in millimeters from the cemento enamel junction to the bottom of the pocket.
The secondary outcome of the study is the recording of gingival index in the 3rd month.
The gingival index is graded as follows: 0 = Normal gingiva = Mild inflammationslight change in color, slight oedema. No bleeding on probing = Moderate inflammation redness, oedema and glazing. Bleeding on probing = Severe inflammation marked redness and oedema. Ulceration. Tendency to spontaneous bleeding.
The secondary outcome of the study is the recording of plaque index in the 3rd month.
The plaque index is graded as follows: 0 = No plaque in the gingival area. = A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may only be recognized by running a probe across the tooth surface. = Moderate accumulation of soft deposits within the gingival pocket, on the gingival margin and/or adjacent tooth surface, which can be seen by the naked eye. = Abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent tooth surface.

Full Information

First Posted
May 8, 2021
Last Updated
May 26, 2021
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT04908098
Brief Title
Diode Laser Application With Non-Surgical Periodontal Treatment
Official Title
Clinical and Biochemical Evaluation of the Effectiveness of Diode Laser Application With Non-Surgical Periodontal Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 10, 2019 (Actual)
Primary Completion Date
August 10, 2020 (Actual)
Study Completion Date
August 10, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe 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
Periodontitis is an infectious disease that causes destruction of periodontal tissues with complex etiology that develops due to local and systemic factors. Host-derived enzymes, cytokines and proinflammatory markers are the main elements that play a role in this degradation. New techniques such as non-surgical or surgical methods combined with laser application are used for its treatment. The subjects were divided into two groups as "Individuals Applied with Diode Laser in Addition to Non-Surgical Periodontal Treatment" (Laser group) and "Individuals with Non-Surgical Periodontal Treatment (SRP)" (Control group). While only non-surgical periodontal treatment was applied to individuals in the control group; In the laser group, diode laser was applied in addition to this treatment. All individuals were examined 1 and 3 months after treatment.The scaling root planing (SRP) procedure was performed mechanically with gracey curettes under local anesthesia. The diode laser applied to the study group was applied parallel to the gingival sulcus at 0.80W power, 940 nm wavelength and 0.80 J / s energy level in continuous phase. Gingival crevicular fluid (GCF) samples were taken without any procedure in order not to change the amount and content. All clinical parameters were also measured by the same investigator before SRP and in all participants. After this treatment, the participants were re-examined in the 1st and 3rd months for control purposes and GCF samples were taken from the same regions again and the clinical parameters were measured again by the same researcher. GCF samples were stored at -20 degrees Celsius until ELISA studies were performed. Clinical parameters (pocket depth, clinical attachment loss, bleeding on probing, gingival index, plaque index) and gingival crevicular fluid (GCF) sampling were obtained at each control. IL-1β, IL-10, IL-17, OPG, RANKL, TWEAK, Sclerostin levels in GCF samples were measured with ELISA method. The aim of this study is to evaluate the effectiveness of diode laser application in addition to non-surgical treatment in periodontitis treatment clinically and biochemically and to assess the potential biomarkers for use.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis
Keywords
periodontitis, Gingival crevicular fluid, diode laser, sclerostin, TWEAK

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants were divided into two groups as study and control.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Laser group
Arm Type
Experimental
Arm Description
Root-planning was performed using Gracey curettes in the areas where periodontal pockets were diagnosed after scaling. Laser application was then applied to the areas where root planning was applied. Laser was applied in continuous phase at 0.80W power, 940 nm wavelength and 0.80 J / s energy level.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Root-planning was performed using Gracey curettes in the areas where periodontal pockets were diagnosed after scaling.
Intervention Type
Device
Intervention Name(s)
diode laser
Intervention Description
It is the application of the laser tip parallel to the inner surface of the periodontal pocket
Intervention Type
Procedure
Intervention Name(s)
scaling - root planning
Intervention Description
Scaling is the removal of calculus and other deposits in the root of the tooth.Root planning is the removal of necrotic cementum on the tooth root surface. Scaler and gracey curettes are used for these operations.
Primary Outcome Measure Information:
Title
The primary outcome of the study was the control examination performed 3 months after the first examination. At the 3rd month control, the same researcher measured clinical parameters from all patients
Description
Probing depth is the measurement from the free gingival margin, to the base of the pocket in millimeters of the distance. Periodontal probe is used.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
The secondary outcome of the study is the recording of bleeding index in the 3rd month.
Description
The bleeding index is evaluated as positive if there is bleeding in the gingiva during probing.
Time Frame
3 months
Title
Another outcome of the study is the collection of gingival crevicular fluid samples in the 3rd month.
Description
Samples are obtained by means of paper strips placed gently in the gingival groove. These samples are stored at -20 ° C for later analysis by ELISA method.
Time Frame
3 months
Title
The secondary outcome of the study is a measure of the clinical attachment level.
Description
The distance in millimeters from the cemento enamel junction to the bottom of the pocket.
Time Frame
3 months
Title
The secondary outcome of the study is the recording of gingival index in the 3rd month.
Description
The gingival index is graded as follows: 0 = Normal gingiva = Mild inflammationslight change in color, slight oedema. No bleeding on probing = Moderate inflammation redness, oedema and glazing. Bleeding on probing = Severe inflammation marked redness and oedema. Ulceration. Tendency to spontaneous bleeding.
Time Frame
3 months
Title
The secondary outcome of the study is the recording of plaque index in the 3rd month.
Description
The plaque index is graded as follows: 0 = No plaque in the gingival area. = A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may only be recognized by running a probe across the tooth surface. = Moderate accumulation of soft deposits within the gingival pocket, on the gingival margin and/or adjacent tooth surface, which can be seen by the naked eye. = Abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent tooth surface.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Presence of 5mm or more periodontal pockets on one or more surfaces in periodontal tissues, Not having periodontal treatment in the last 3 months, The informed consent form must be approved, At least 18 years old. Exclusion Criteria: Presence of systemic disease, Smoking, Regular use of non-steroidal anti inflammatory drugs, Having been treated with antibiotics in the last 3 months, Individuals in need of pre-treatment antibiotic prophylaxis, Pregnancy and lactation, Not approving the informed consent form, Patients with known allergies.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali Tuğrul Gür, Dentist
Organizational Affiliation
Principal Investigator
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Güliz Nigar Güncü, Professor
Organizational Affiliation
study director
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Abdullah Cevdet Akman, professor
Organizational Affiliation
Study principal investigator
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rahime Meral Nohutcu, professor
Organizational Affiliation
study principal investigator
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Aslı Pınar, Professor
Organizational Affiliation
biochemistry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hacettepe Universty
City
Ankara
ZIP/Postal Code
06100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The individual data of the participants will not be shared. Statistical analysis of the study will be shared.

Learn more about this trial

Diode Laser Application With Non-Surgical Periodontal Treatment

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