Comparative evaluation of efficacy of amniotic membrane with demineralized freeze dried bone allograft versus collagen membrane with demineralized freeze dried bone allograft in the treatment of intrabony defects – A clinico - radiographic study
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- relative intrabony defect component level [rIBD]
研究概览
简要总结
COMPARATIVE EVALUATION OF EFFICACY OF AMNIOTIC MEMBRANE WITH DEMINERALIZED FREEZE DRIED BONE ALLOGRAFT VERSUS COLLAGEN MEMBRANE WITH DEMINERALIZED FREEZE DRIED BONE ALLOGRAFT IN THE TREATMENT OF INTRABONY DEFECTS – A CLINICO-RADIOGRAPHIC STUDY.
clinical standardized parameters measured are :
**1. GINGIVAL INDEX (Loe and Silness in 1963)
-
PLAQUE INDEX (Turesky- Gilmore- Glickman modification of Queigly- Hein Plaque index in 1970)
-
POCKET PROBING DEPTH in mm (from gingival margin to the base of the sulcus).
-
RELATIVE CLINICAL ATTACHMENT LEVEL in mm (from the fixed reference point to the base of the sulcus).
5. The relative intrabony defect component level [rIBD] was measured between the cementoenamel junction (CEJ) and the most apical extension of the defect by counting the number of squares of 1 mm in a grid.**
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Systemically healthy subjects.
- •Subjects with age between 18-60 years.
- •Patients having periodontal pockets with probing depth more than or equal to 5 mm
- •Patients suffering with chronic periodontitis requiring surgical intervention to treat an Intra bony defect adjacent to a natural tooth.
- •Patients showing radiographic evidence of infrabony osseous defect.
- •Patients who were willing to comply with all the study related procedures and who signed the informed consent form.
排除标准
- •Patients who were medically compromised
- •Patients with inadequate plaque control.
- •Women who were pregnant or who intended to become pregnant during the study period.
- •Oral cancer or head and neck radiation within 6 months
- •Smoking >10 cigarettes per day; daily use of smokeless tobacco, pipe, or cigar smoking
- •Untreated infection at the study site other than periodontitis.
- •Patients with any history of allergy to the material used in this study.
- •Patients who were on antibiotics or antimicrobial therapy for last 6 months
- •Patients on any drug therapy which is known to influence the periodontium.
- •Patients who have undergone any type of periodontal flap surgical procedure or regenerative therapy 6 months prior to the initial examination.
- •Patients unable to provide informed consent.
结局指标
主要结局
relative intrabony defect component level [rIBD]
时间窗: At Baseline and 6 Months
次要结局
- 1. GINGIVAL INDEX (Loe and Silness in 1963)(2. PLAQUE INDEX (Turesky- Gilmore- Glickman modification of Queigly- Hein Plaque index in 1970))