Diode Laser-Assisted Periodontal Therapy Enhances Clinical Outcomes for Deep Periodontal Pockets in Smokers

October 2, 2025 updated by: Deniz irem Atasoy Erdogan, Selcuk University

Diode Laser-Assisted Periodontal Therapy Enhances Clinical Outcomes for Deep Periodontal Pockets in Smokers: A Randomized Clinical Trial

This study investigated the adjunctive effects of diode laser therapy in smokers with severe periodontitis. Thirty-three patients were randomized to non-surgical periodontal therapy (SRP) with or without diode laser. Clinical parameters and salivary oxidative stress markers (MDA, 8-OHdG) were assessed at baseline, 1, and 3 months. Both groups showed improvements, but SRP+DL resulted in significantly greater reductions in deep pockets, PISA, PESA, PI, and MDA at 3 months. These findings suggest that diode laser therapy may enhance conventional treatment by improving clinical outcomes and reducing oxidative stress in smokers with severe periodontitis.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
33

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Selçuklu
      • Konya, Selçuklu, Turkey (Türkiye), 42250
        • Selcuk University Faculty of Dentistry Department of Periodontology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • no periodontal treatment within the previous 6 months;
  • no use of antibiotics within the previous 3 months;
  • no systemic disease and alcohol drinkers, or drug users;
  • no use of anti-inflammatory drugs within the past 3 months;
  • no pregnancy;
  • no use of hormonal contraceptives; and
  • current smokers with a history of smoking ≥10 cigarettes per day for at least one year.

Exclusion Criteria:

  • Patients with <20 teeth, grade III tooth mobility, partial dentures, or fixed prostheses were excluded. Additionally, those with dental implants or peri-implant diseases were also excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Stage III Grade C :Non surgical periodontal therapy and an adjunct diode laser use
Device: Diode Laser Application in Deep Periodontal Pockets
A 940 nm indium-gallium-aluminum-phosphate diode laser (Ezlase, Biolase, USA) with a 400 μm fiber was used in contact mode at 1.5 W, pulse 20/20 ms, 20 s/cm², power density 1.061 W/cm², and 15 J/cm² energy in deep periodontal pockets.
Procedure: Professional Mechanical Plaque Removal
Professional mechanical removal of supragingival plaque and calculus
Procedure: Scaling and Root Planing
Subgingival scaling and root planing
Experimental: Stage III Grade C :Non surgical periodontal therapy
Procedure: Professional Mechanical Plaque Removal
Professional mechanical removal of supragingival plaque and calculus
Procedure: Scaling and Root Planing
Subgingival scaling and root planing

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Probing Pocket Dept (PPD)
Time Frame: Through study completion, an average of 3 months.
The probing pocket dept was assessed on six tooth surfaces, inluding the mesiobuccal, buccal, distobuccal, mesiolingual, lingual and distolingual areas of each tooth.
Through study completion, an average of 3 months.
Periodontal Epithelial Surface Area (PESA)
Time Frame: Through study completion, an average of 3 months.
PESA represents the total epithelial surface area in periodontal pockets.
Through study completion, an average of 3 months.
Periodontal Inflamed Surface Area (PISA)
Time Frame: Through study completion, an average of 3 months.
PISA quantifies the inflamed portion of this surface area by integrating only sites exhibiting BOP, both measured in mm2.
Through study completion, an average of 3 months.
Salivary Malondialdehyde Levels
Time Frame: Through study completion, an average of 3 months.
Evaluation of salivary malondialdehyde levels.
Through study completion, an average of 3 months.
Salivary 8-hydroxy-2'-deoxyguanosine Levels
Time Frame: Through study completion, an average of 3 months.
Evaluation of salivary 8-hydroxy-2'-deoxyguanosine levels.
Through study completion, an average of 3 months.
PPD ≥4 mm, site-specific PPD (ssPPD)
Time Frame: Through study completion, an average of 3 months.
For sites with PPD ≥4 mm, site-specific PPD (ssPPD) values was calculated.
Through study completion, an average of 3 months.
PPD ≥4 mm, site spesific CAL (ssCAL)
Time Frame: Through study completion, an average of 3 months.
For sites with PPD ≥4 mm, site spesific CAL (ssCAL) values were also calculated.
Through study completion, an average of 3 months.
PPD ≥4 mm, site-specific PISA (ssPISA)
Time Frame: Through study completion, an average of 3 months.
For sites with PPD ≥4 mm, site-specific PISA (ssPISA) values were calculated.
Through study completion, an average of 3 months.
PPD ≥4 mm, site-specific PESA (ssPESA)
Time Frame: Through study completion, an average of 3 months.
For sites with PPD ≥4 mm, site-specific PESA (ssPESA) values were calculated.
Through study completion, an average of 3 months.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Plaque Index (PI)
Time Frame: Through study completion, an average of 3 months.
The plaque index was assessed on six tooth surfaces, inluding the mesiobuccal, buccal, distobuccal, mesiolingual, lingual and distolingual areas of each tooth.
Through study completion, an average of 3 months.
Bleeding on Probing (BOP)
Time Frame: Through study completion, an average of 3 months.
The bleeding on probing index was assessed on six tooth surfaces, inluding the mesiobuccal, buccal, distobuccal, mesiolingual, lingual and distolingual areas of each tooth.
Through study completion, an average of 3 months.
Clinical Attachment Level (CAL)
Time Frame: Through study completion, an average of 3 months.
The clinical attachment level was assessed on six tooth surfaces, inluding the mesiobuccal, buccal, distobuccal, mesiolingual, lingual and distolingual areas of each tooth.
Through study completion, an average of 3 months.
Gingival Index (GI)
Time Frame: Through study completion, an average of 3 months.
The gingival index was assessed on six tooth surfaces, inluding the mesiobuccal, buccal, distobuccal, mesiolingual, lingual and distolingual areas of each tooth.
Through study completion, an average of 3 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Selcuk University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Scientific and Technological Research Council of Turkey
Selcuk University Scientific Research Projects Unit

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 10, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 21, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 5, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 29, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 2, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 9, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 9, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 2, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SU-DIAE-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Smoking

Clinical Trials on Diode Laser Application in Deep Periodontal Pockets

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings