Comparison of the Effectiveness of Two Different Periodontal Wound Dressings in Non-Surgical Periodontal Therapy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 25
- 主要终点
- Change in Probing Pocket Depth (PPD)
研究概览
简要总结
This study aims to evaluate and compare the efficacy of two different eugenol-free periodontal dressing materials-Ora-Aid (a hydrophilic polymer) and Coe-Pak (a zinc oxide-based paste)-following non-surgical periodontal treatment (scaling and root planing, SRP) in patients with Stage 3, Grade A periodontitis. The study utilizes a split-mouth design to analyze clinical periodontal parameters, patient comfort, and microbiological changes over a 3-month period.
详细描述
Scope:
Tooth surface cleaning and root surface planing are integral parts of non-surgical periodontal treatment to remove bacterial plaque and tartar from diseased root surfaces. Periodontal wound dressings began to be used in the early 19th century to protect periodontal wounds. These wound dressings provide protection in the treated area and, by remaining in close contact with the tissue and tooth, help stabilize the clot and protect it from external and internal forces during function. It has also been reported that tooth surface cleaning and root surface planing cause separation and structural damage in the lingual and buccal soft tissues. The use of periodontal dressings is recommended to improve the health of these damaged tissues and reduce patient discomfort.
The aim of this study is to analyze the clinical parameters, patient comfort, and microbiological benefits of different wound dressings used in dental calculus removal and root planing in the treatment of patients with periodontitis.
Topic: Periodontitis is a multifactorial, non-infectious disease that can lead to tooth loss if left untreated. Advanced stages of periodontitis can affect chewing ability, nutritional status, and quality of life.
Scaling, root planing, and mechanical removal of plaque should be considered a fundamental part of initial periodontal treatment. Furthermore, in patients who participate in a regular maintenance program following scaling and root planing, less tooth loss and clinical attachment loss are observed. Scaling and root planing are an integral part of non-surgical periodontal treatment to remove bacterial plaque and calculus from diseased root surfaces.
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
The primary investigator responsible for clinical data collection and sample procurement is masked to the treatment allocation. Specifically, the examiner performing the periodontal measurements (GI, PI, PBI, BOP, PPD, and CAL) and collecting the subgingival plaque samples at baseline, 1 month, and 3 months is blinded to which quadrants received the Ora-Aid or Coe-Pak dressings. To maintain this blinding, the dressings are removed by a separate clinician one week post-treatment, ensuring that the examining researcher has no knowledge of the intervention assigned to each split-mouth site during the follow-up evaluations.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Systemically healthy volunteers aged 18-45 years.
- •Diagnosis of Periodontitis (Stage 3, Grade A).
- •Presence of at least 20 permanent teeth.
- •Capacity to understand the study protocol and provide informed consent.
排除标准
- •Systemic diseases (e.g., Diabetes, Chronic Renal Failure, Cancer, Connective Tissue Disorders).
- •Pregnancy or breastfeeding.
- •Smoking (>10 cigarettes/day).
- •Antibiotic use within the last 3 months or periodontal treatment within the last year.
- •Presence of orthodontic appliances, removable prostheses, or extensive interproximal caries.
研究组 & 干预措施
Ora-aid side
A split-mouth study design has been planned for the same patient. The patient's right or left upper and lower jaws will be covered with Ora-Aid or periodontal paste after initial periodontal treatment. Which side will receive Ora-Aid and which side will receive periodontal paste will be determined by a coin toss. After full mouth scaling and root planing in the same session, Ora-Aid wound dressing or periodontal pat will be applied to the 1st and 3rd quadrants. Patients will be given oral hygiene instructions and asked to avoid brushing the periodontal dressing area while the dressings are in place. The wound dressings will be removed after 1 week.
干预措施: Coe-Pack application (Procedure)
Coe-pack side
A split-mouth study design has been planned for the same patient. The patient's right or left upper and lower jaws will be covered with Ora-Aid or periodontal paste after initial periodontal treatment. Which side will receive Ora-Aid and which side will receive periodontal paste will be determined by a coin toss. After full mouth scaling and root planing in the same session, Ora-Aid wound dressing or periodontal pat will be applied to the 1st and 3rd quadrants. Patients will be given oral hygiene instructions and asked to avoid brushing the periodontal dressing area while the dressings are in place. The wound dressings will be removed after 1 week.
干预措施: Ora Aid application (Procedure)
结局指标
主要结局
Change in Probing Pocket Depth (PPD)
时间窗: Baseline, 1st and 3rd months
PPD will be measured at six sites per tooth using a calibrated periodontal probe. The mean value per patient will be calculated. A decrease in PPD indicates clinical improvement. Unit of Measure: Millimeters (mm)
total bacterial load
时间窗: baseline, 1 month, and 3 months
This study involves the longitudinal comparison of total bacterial load, assessed via plaque samples collected from the deepest periodontal pockets on both the right and left sides at baseline, 1 month, and 3 months post-treatment.
次要结局
- Evoluation of Gingival Index (GI)(Baseline, 1st and 3rd months.)
- Plaque Index (PI) Scores(Baseline, 1 month, 3 months.)
- Percentage of Sites with Bleeding on Probing (BOP)(Baseline, 1 month, 3 months.)
- Change in Clinical Attachment Loss (CAL)(Baseline, 1 month, 3 months.)
研究者
SEVAL CEYLAN ŞEN
Assistant Professor
Saglik Bilimleri Universitesi