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

NCT07213752 | Completed FDA Device

• 1 other identifier: SU-DIAE-01
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

adjunctive periodontal treatment; diode laser therapy; non-surgical periodontal therapy; smokers with periodontitis; malondialdehyde; 8-hydroxy-2'-deoxyguanosine

Outcome Measures

Primary Outcomes (9)

• 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.

  Through study completion, an average of 3 months.

• Periodontal Epithelial Surface Area (PESA)

  PESA represents the total epithelial surface area in periodontal pockets.

  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.

  Through study completion, an average of 3 months.

• Salivary Malondialdehyde Levels

  Evaluation of salivary malondialdehyde levels.

  Through study completion, an average of 3 months.

• Salivary 8-hydroxy-2'-deoxyguanosine Levels

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

  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.

  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.

  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.

  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.

  Through study completion, an average of 3 months.

Secondary Outcomes (4)

• Plaque Index (PI)

  Through study completion, an average of 3 months.

• Bleeding on Probing (BOP)

  Through study completion, an average of 3 months.

• Clinical Attachment Level (CAL)

  Through study completion, an average of 3 months.

• Gingival Index (GI)

  Through study completion, an average of 3 months.

Study Arms (2)

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

Interventions

Diode Laser Application in Deep Periodontal Pockets DEVICE

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.

Stage III Grade C :Non surgical periodontal therapy and an adjunct diode laser use

Professional Mechanical Plaque Removal PROCEDURE

Professional mechanical removal of supragingival plaque and calculus

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 Planing PROCEDURE

Subgingival scaling and root planing

Stage III Grade C :Non surgical periodontal therapy; Stage III Grade C :Non surgical periodontal therapy and an adjunct diode laser use

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Selcuk University: lead
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (1)

Selcuk University Faculty of Dentistry Department of Periodontology

Konya, Selçuklu, 42250, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periodontitis; Periodontal Diseases; Smoking

Interventions

Tooth Exfoliation; Root Planing

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Dental Scaling; Dental Prophylaxis; Periodontics; Dentistry; Subgingival Curettage; Preventive Dentistry

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: To ensure allocation concealment and maintain the masked design, the following protocol was applied: After diagnosis at the Department of Oral Diagnosis and Radiology, baseline periodontal records and anamnesis were documented, and each patient was assigned a unique ID. Eligible participants underwent baseline clinical measurements (D.İ.A) and saliva sampling. Patients were then randomly allocated to SRP (n=17) or SRP+DL (n=16) using a computer-generated program (Sealed Envelope Ltd.) by an independent clinician not involved in the study. One week later, SRP and diode laser procedures were performed by the same clinician (D.İ.A). For blinding, all clinical files were anonymized and coded by the study supervisor (S.S.H). Statistical analyses were conducted by a blinded statistician without access to group assignments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deniz Irem Atasoy Erdoğan

Study Record Dates

• First Submitted: September 29, 2025
• First Posted: October 9, 2025
• Study Start: December 10, 2023
• Primary Completion: January 21, 2025
• Study Completion: June 5, 2025
• Last Updated: October 9, 2025

Record last verified: 2023-12

Locations

TU (1)