Diode Laser-Assisted Periodontal Therapy Enhances Clinical Outcomes for Deep Periodontal Pockets in Smokers: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Salivary Malondialdehyde Levels
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Stage III Grade C :Non surgical periodontal therapy and an adjunct diode laser use
干预措施: Diode Laser Application in Deep Periodontal Pockets (Device)
Stage III Grade C :Non surgical periodontal therapy and an adjunct diode laser use
干预措施: Professional Mechanical Plaque Removal (Procedure)
Stage III Grade C :Non surgical periodontal therapy and an adjunct diode laser use
干预措施: Scaling and Root Planing (Procedure)
Stage III Grade C :Non surgical periodontal therapy
干预措施: Professional Mechanical Plaque Removal (Procedure)
Stage III Grade C :Non surgical periodontal therapy
干预措施: Scaling and Root Planing (Procedure)
结局指标
主要结局
Salivary Malondialdehyde Levels
时间窗: Through study completion, an average of 3 months.
Evaluation of salivary malondialdehyde levels.
Probing Pocket Dept (PPD)
时间窗: 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)
时间窗: Through study completion, an average of 3 months.
PESA represents the total epithelial surface area in periodontal pockets.
Periodontal Inflamed Surface Area (PISA)
时间窗: 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 8-hydroxy-2'-deoxyguanosine Levels
时间窗: Through study completion, an average of 3 months.
Evaluation of salivary 8-hydroxy-2'-deoxyguanosine levels.
PPD ≥4 mm, site-specific PPD (ssPPD)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: Through study completion, an average of 3 months.
For sites with PPD ≥4 mm, site-specific PESA (ssPESA) values were calculated.
次要结局
- 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.)
研究者
Deniz irem Atasoy Erdogan
Deniz Irem Atasoy Erdoğan
Selcuk University