Evaluation of a New In-office and Domiciliary Ozonized Gel for the Management of Periodontal Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in R - Gingival recession
研究概览
简要总结
The aim of this study is to evaluate the efficacy of non-surgical periodontal therapy with supportive home oral care for the treatment of periodontal disease.
Patients with bilateral periodontal pathological sites will undergo professional dental hygiene with ultrasonic handpiece (Piezon EMS with PerioSlim inserts) followed by manual instrumentation with Gracey curettes and application of erythritol Airflow powders. Then, patients will be randomly divided into two groups according to a split-mouth design: the Control Group will undergo a split-mouth application of chlorhexidine gel 1% for quadrants 1/3 (or 2/4), while for the Trial Group Ozoral Pro for quadrants 2/4 (or 1/3) will be used. Patients will use the products at home with one daily application for the following 14 days after the visits. The Trial Group will use Ozoral Gel for home applications.
The following indexes will be assessed at baseline, T1 (1 month), T2 (3 months) and T3 (6 months): recession, PPD, BoP %, CAL, PCR %. Contextually, the application of the two gels will be performed.
详细描述
The aim of this study is to evaluate the efficacy of non-surgical periodontal therapy with supportive home oral care for the treatment of periodontal disease comparing chlorhexidine and ozone gels.
Patients with bilateral periodontal pathological sites will undergo professional dental hygiene with ultrasonic handpiece (Piezon EMS with PerioSlim inserts) followed by manual instrumentation with Gracey curettes and application of erythritol Airflow powders. Then, patients will be randomly divided into two groups according to a split-mouth design:
- Control Group: application of chlorhexidine gel 1% for quadrants 1/3 (or 2/4)
- Trial Group: administration of Ozoral Pro for quadrants 2/4 (or 1/3).
Patients will use the products at home with one daily application for the following 14 days after the visits. The Trial Group will use Ozoral Gel for home applications.
The following indexes will be assessed at baseline, T1 (1 month), T2 (3 months) and T3 (6 months): recession, PPD, BoP %, CAL, PCR %. Contextually, the application of the two gels will be performed.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Gels concealed
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of bilateral periodontal sites according to the new Classification of Periodontal and Peri-implant Diseases (Severity: Staging I; Complexity: Staging II).
- •No systemic disease;
- •Compliant patients.
排除标准
- •Absence of dental implants;
- •Neurological and psychiatric diseases;
- •Patients taking bisphosphonates during the previous 12 months from the beginning of the study;
- •Pregnant and/or breastfeeding women;
- •Patients undergoing anticancer therapy.
- •Patients with poor compliance.
结局指标
主要结局
Change in R - Gingival recession
时间窗: Time Frame: baseline, 1, 3 and 6 months after baseline
Distance (in mm) between the gingival margin and the amelo-cemental junction.
Change in Bleeding on Probing (BOP%)
时间窗: Time Frame: baseline, 1, 3 and 6 months after baseline
Dichotomous scoring (yes/no) of bleeding sites
Change in Plaque Control Record (PCR%)
时间窗: Time Frame: baseline, 1, 3 and 6 months after baseline
% assessment of the amount of plaque on dental surfaces; it is detected on 4 surfaces: distal, mesial, vestibular, lingual / palatal. The number of sites with plaque is divided by the total number of sites available in the mouth and multiplied by 100. Results indicate the index as a percentage.
Change in PPD - Probing Pocket Depth
时间窗: Time Frame: baseline, 1, 3 and 6 months after baseline
Evaluation (in mm) of the depth of the gingival sulcus, through a millimeter periodontal probe; it is detected from the gingival margin to the bottom of the gingival sulcus or periodontal pocket, evaluated at 6 sites.
Change in Dental mobility (Miller, 1985)
时间窗: Time Frame: baseline, 1, 3 and 6 months after baseline
Scoring criteria * Grade 0: oscillation within 0.2 mm; the teeth move naturally and there are no mobility problems; * Grade I: horizontal mobility of the tooth from 0.2 to 1 mm; * Grade II: horizontal mobility of the tooth from 1 to 2 mm; * Grado III: horizontal mobility equal to or greater than 3 mm or vertical mobility of the tooth.
次要结局
未报告次要终点
研究者
Andrea Scribante
Research Resident, Principal Investigator
University of Pavia