PeriodontitisNCT07213752
Diode Laser-Assisted Periodontal Therapy Enhances Clinical Outcomes for Deep Periodontal Pockets in Smokers
A study testing Diode Laser Application in Deep Periodontal Pockets, Professional Mechanical Plaque Removal and Scaling and Root Planing in people with Periodontitis and Periodontitis Stage III, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Periodontitis Stage III, Periodontal Disease
- What is being tested?
- Diode Laser Application in Deep Periodontal Pockets, Professional Mechanical Plaque Removal and Scaling and Root Planing
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Dec 2023to 5 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Selcuk University Faculty of Dentistry Department of Periodontology
Konya, Selçuklu, 42250
About this study
Official title: 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.
- Conditions
- Periodontitis, Periodontitis Stage III, Periodontal Disease, Diode Laser Therapy, Smoking, Malondialdehyde
- Being tested
- Diode Laser Application in Deep Periodontal Pockets, Professional Mechanical Plaque Removal, Scaling and Root Planing
- Keywords
- adjunctive periodontal treatment, diode laser therapy, non-surgical periodontal therapy, smokers with periodontitis, malondialdehyde, 8-hydroxy-2'-deoxyguanosine
- Medical subject headings
- Periodontitis, Periodontal Diseases, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diode Laser Application in Deep Periodontal PocketsDevice
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 Plaque RemovalProcedure or surgery
Professional mechanical removal of supragingival plaque and calculus
Scaling and Root PlaningProcedure or surgery
Subgingival scaling and root planing
| Study group | Role | What they receive |
|---|---|---|
| Stage III Grade C :Non surgical periodontal therapy and an adjunct diode laser use | Experimental | Not described Receives: Device: Diode Laser Application in Deep Periodontal Pockets; Procedure: Professional Mechanical Plaque Removal; Procedure: Scaling and Root Planing |
| Stage III Grade C :Non surgical periodontal therapy | Experimental | Not described Receives: Procedure: Professional Mechanical Plaque Removal; Procedure: Scaling and Root Planing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing Pocket Dept (PPD)
The probing pocket dept was assessed on six tooth surfaces, inluding the mesiobuccal, buccal, distobuccal, mesiolingual, lingual and distolingual areas of each tooth.
Measured: Through study completion, an average of 3 months.
Periodontal Epithelial Surface Area (PESA)
PESA represents the total epithelial surface area in periodontal pockets.
Measured: Through study completion, an average of 3 months.
Periodontal Inflamed Surface Area (PISA)
PISA quantifies the inflamed portion of this surface area by integrating only sites exhibiting BOP, both measured in mm2.
Measured: Through study completion, an average of 3 months.
Salivary Malondialdehyde Levels
Evaluation of salivary malondialdehyde levels.
Measured: Through study completion, an average of 3 months.
Salivary 8-hydroxy-2'-deoxyguanosine Levels
Evaluation of salivary 8-hydroxy-2'-deoxyguanosine levels.
Measured: Through study completion, an average of 3 months.
PPD ≥4 mm, site-specific PPD (ssPPD)
For sites with PPD ≥4 mm, site-specific PPD (ssPPD) values was calculated.
Measured: Through study completion, an average of 3 months.
PPD ≥4 mm, site spesific CAL (ssCAL)
For sites with PPD ≥4 mm, site spesific CAL (ssCAL) values were also calculated.
Measured: Through study completion, an average of 3 months.
PPD ≥4 mm, site-specific PISA (ssPISA)
For sites with PPD ≥4 mm, site-specific PISA (ssPISA) values were calculated.
Measured: Through study completion, an average of 3 months.
PPD ≥4 mm, site-specific PESA (ssPESA)
For sites with PPD ≥4 mm, site-specific PESA (ssPESA) values were calculated.
Measured: Through study completion, an average of 3 months.
Secondary outcomes (4)
Plaque Index (PI)
The plaque index was assessed on six tooth surfaces, inluding the mesiobuccal, buccal, distobuccal, mesiolingual, lingual and distolingual areas of each tooth.
Measured: Through study completion, an average of 3 months.
Bleeding on Probing (BOP)
The bleeding on probing index was assessed on six tooth surfaces, inluding the mesiobuccal, buccal, distobuccal, mesiolingual, lingual and distolingual areas of each tooth.
Measured: Through study completion, an average of 3 months.
Clinical Attachment Level (CAL)
The clinical attachment level was assessed on six tooth surfaces, inluding the mesiobuccal, buccal, distobuccal, mesiolingual, lingual and distolingual areas of each tooth.
Measured: Through study completion, an average of 3 months.
Gingival Index (GI)
The gingival index was assessed on six tooth surfaces, inluding the mesiobuccal, buccal, distobuccal, mesiolingual, lingual and distolingual areas of each tooth.
Measured: Through study completion, an average of 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2025
- Study start10 Dec 2023
- Primary completion21 Jan 2025
- Study completion5 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by Selcuk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Deniz irem Atasoy Erdogan, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07213752
- Sponsor's protocol ID
- SU-DIAE-01
- Status last verified
- Dec 2023
- First submitted
- 29 Sep 2025
- Last updated
- 9 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diode Laser-Assisted Periodontal Therapy Enhances Clinical Outcomes for Deep Periodontal Pockets in Smokers: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07213752
- Acronym / sponsor ID
- SU-DIAE-01
- Conditions
- Periodontitis, Periodontitis Stage III, Periodontal Disease, Diode Laser Therapy, Smoking, Malondialdehyde
- Keywords
- adjunctive periodontal treatment, diode laser therapy, non-surgical periodontal therapy, smokers with periodontitis, malondialdehyde, 8-hydroxy-2'-deoxyguanosine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 10 Dec 2023 (actual)
- Primary completion
- 21 Jan 2025 (actual)
- Study completion
- 5 Jun 2025 (actual)
- First posted
- 9 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stage III Grade C :Non surgical periodontal therapy and an adjunct diode laser use | Experimental | Device: Diode Laser Application in Deep Periodontal Pockets, Procedure: Professional Mechanical Plaque Removal, Procedure: Scaling and Root Planing |
| Stage III Grade C :Non surgical periodontal therapy | Experimental | Procedure: Professional Mechanical Plaque Removal, Procedure: Scaling and Root Planing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diode Laser Application in Deep Periodontal PocketsA 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. | Device | Stage III Grade C :Non surgical periodontal therapy and an adjunct diode laser use |
| Professional Mechanical Plaque RemovalProfessional mechanical removal of supragingival plaque and calculus | Procedure or surgery | Stage III Grade C :Non surgical periodontal therapy, Stage III Grade C :Non surgical periodontal therapy and an adjunct diode laser use |
| Scaling and Root PlaningSubgingival scaling and root planing | Procedure or surgery | Stage III Grade C :Non surgical periodontal therapy, Stage III Grade C :Non surgical periodontal therapy and an adjunct diode laser use |
Primary outcome
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.
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.
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.
Salivary Malondialdehyde Levels
Time frame: Through study completion, an average of 3 months.
Evaluation of salivary malondialdehyde levels.
Salivary 8-hydroxy-2'-deoxyguanosine Levels
Time frame: Through study completion, an average of 3 months.
Evaluation of salivary 8-hydroxy-2'-deoxyguanosine levels.
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.
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.
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.
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.
4 secondary outcomes
Plaque Index (PI)
Time frame: Through study completion, an average of 3 months.
Bleeding on Probing (BOP)
Time frame: Through study completion, an average of 3 months.
Clinical Attachment Level (CAL)
Time frame: Through study completion, an average of 3 months.
Gingival Index (GI)
Time frame: Through study completion, an average of 3 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diode Laser Application in Deep Periodontal Pockets, Professional Mechanical Plaque Removal and Scaling and Root Planing in people with Periodontitis and Periodontitis Stage III, run by Selcuk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probing Pocket Dept (PPD) (time frame: Through study completion, an average of 3 months.). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2025.