Diode Laser Application With Non-Surgical Periodontal Treatment

NCT ID: NCT04908098

Last Updated: 2021-06-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-10
• Study Completion Date: 2021-08-10

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Laser group

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.

Group Type: EXPERIMENTAL

diode laser

Intervention Type: DEVICE

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

scaling - root planning

Intervention Type: 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

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

Group Type: ACTIVE_COMPARATOR

scaling - root planning

Intervention Type: 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.

Interventions

diode laser

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

Intervention Type: DEVICE

scaling - root planning

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hacettepe University

OTHER

Sponsor Role: lead

Responsible Party

Ali Tugrul Gur

principal investigator, research assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ali Tuğrul Gür, Dentist

Role: PRINCIPAL_INVESTIGATOR

Principal Investigator

Güliz Nigar Güncü, Professor

Role: STUDY_DIRECTOR

study director

Abdullah Cevdet Akman, professor

Role: PRINCIPAL_INVESTIGATOR

Study principal investigator

Rahime Meral Nohutcu, professor

Role: PRINCIPAL_INVESTIGATOR

study principal investigator

Aslı Pınar, Professor

Role: PRINCIPAL_INVESTIGATOR

biochemistry

Locations

Hacettepe Universty

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

TSA-2019-18111

Identifier Type: -

Identifier Source: org_study_id