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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
What is being tested?
Diode Laser Application in Deep Periodontal Pockets, Professional Mechanical Plaque Removal and Scaling and Root Planing
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

Other trials in Turkey (Türkiye)

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.

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 groups in NCT07213752
Study groupRoleWhat they receive
Stage III Grade C :Non surgical periodontal therapy and an adjunct diode laser useExperimentalNot 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 therapyExperimentalNot 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.

  1. 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.

  2. Periodontal Epithelial Surface Area (PESA)

    PESA represents the total epithelial surface area in periodontal pockets.

    Measured: Through study completion, an average of 3 months.

  3. 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.

  4. Salivary Malondialdehyde Levels

    Evaluation of salivary malondialdehyde levels.

    Measured: Through study completion, an average of 3 months.

  5. Salivary 8-hydroxy-2'-deoxyguanosine Levels

    Evaluation of salivary 8-hydroxy-2'-deoxyguanosine levels.

    Measured: Through study completion, an average of 3 months.

  6. 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.

  7. 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.

  8. 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.

  9. 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)
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  1. First posted9 Oct 2025
  2. Study start10 Dec 2023
  3. Primary completion21 Jan 2025
  4. Study completion5 Jun 2025

Resources

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)
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

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.

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