Diode Laser Application With Non-Surgical Periodontal Treatment

NCT04908098 | Unknown

• 1 other identifier: TSA-2019-18111
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis

Keywords

periodontitis; Gingival crevicular fluid; diode laser; sclerostin; TWEAK

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Secondary Outcomes (5)

• The secondary outcome of the study is the recording of bleeding index in the 3rd month.

  3 months

• Another outcome of the study is the collection of gingival crevicular fluid samples in the 3rd month.

  3 months

• The secondary outcome of the study is a measure of the clinical attachment level.

  3 months

• The secondary outcome of the study is the recording of gingival index in the 3rd month.

  3 months

• The secondary outcome of the study is the recording of plaque index in the 3rd month.

  3 months

Study Arms (2)

Laser group

EXPERIMENTAL

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.

Device: diode laser; Procedure: scaling - root planning

Control group

ACTIVE COMPARATOR

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

Procedure: scaling - root planning

Interventions

diode laser DEVICE

It is the application of the laser tip parallel to the inner surface of the periodontal pocket

Laser group

scaling - root planning PROCEDURE

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.

Control group; Laser group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe Universty

Ankara, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periodontitis; Sclerosteosis

Interventions

Lasers, Semiconductor

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Ali Tuğrul Gür, Dentist

  Principal Investigator

  PRINCIPAL INVESTIGATOR

• Güliz Nigar Güncü, Professor

  study director

  STUDY DIRECTOR

• Abdullah Cevdet Akman, professor

  Study principal investigator

  PRINCIPAL INVESTIGATOR

• Rahime Meral Nohutcu, professor

  study principal investigator

  PRINCIPAL INVESTIGATOR

• Aslı Pınar, Professor

  biochemistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator, research assistant

Model Details: Participants were divided into two groups as study and control.

Study Record Dates

• First Submitted: May 8, 2021
• First Posted: June 1, 2021
• Study Start: November 10, 2019
• Primary Completion: August 10, 2020
• Study Completion: August 10, 2021
• Last Updated: June 1, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)