- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07213752
- Original Trial
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
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
33
Phase
- 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
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
Experimental: Stage III Grade C :Non surgical periodontal therapy and an adjunct diode laser use
|
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.
Professional mechanical removal of supragingival plaque and calculus
Subgingival scaling and root planing
|
|
Experimental: Stage III Grade C :Non surgical periodontal therapy
|
Professional mechanical removal of supragingival plaque and calculus
Subgingival scaling and root planing
|
What is the study measuring?
Primary Outcome Measures
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
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.
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)
December 10, 2023
Primary Completion (Actual)
January 21, 2025
Study Completion (Actual)
June 5, 2025
Study Registration Dates
First Submitted
September 29, 2025
First Submitted That Met QC Criteria
October 2, 2025
First Posted (Estimated)
October 9, 2025
Study Record Updates
Last Update Posted (Estimated)
October 9, 2025
Last Update Submitted That Met QC Criteria
October 2, 2025
Last Verified
December 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mouth Diseases
- Stomatognathic Diseases
- Behavior
- Periodontitis
- Periodontal Diseases
- Smoking
- Digestive System and Oral Physiological Phenomena
- Dentistry
- Dental Physiological Phenomena
- Dental Scaling
- Dental Prophylaxis
- Periodontics
- Subgingival Curettage
- Preventive Dentistry
- Root Planing
- Tooth Exfoliation
Other Study ID 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.
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