Gingival Health Around Cervical Carious Lesions Restored With Calcium Silicate Based Cement (Biodentine) Compared With Glass-ionomer Cement: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 主要终点
- Changes in Gingival index around Cervical Carious Lesions Restored with Calcium Silicate Based Cement (Biodentine™) Compared with Glass-Ionomer Cement;
研究概览
简要总结
This study will test if applying calcium silicate cements (Biodentine) to restore cervical carious lesions might adversely affect the gingival health in comparison with conventionally used tooth colored material (GIC)
详细描述
The study will compare two different dental materials on dental lesions near the gum line. . The study will determine if one material is more effective in gingival health, after the placement of the two different dental materials.The oral hygiene and the gingival health of the restored teeth will be evaluated clinically at 1, 3 and 6-month intervals.
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
- Double (Participant, Investigator)
盲法说明
Investigator and participants are blinded to restoration used.
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •good general health;
- •good oral hygiene; and
- •age range 18-60 years old.
- •Patients with the following criteria were excluded:
- •current smokers;
- •pregnant females;
- •or patient with periodontal diseases; and
- •those who had a history of poorly controlled diabetes, liver disease, malignancy, radiotherapy.
排除标准
- •Pregnant women
- •Patients taking benzodiazepines, narcotics and multiple antidepressants for pain management not associated with the oral cavity
- •Patients requiring treatment for more than 5 decayed sites, periodontal disease and root canal therapy
- •Complicated medical history (>4 concurrent treatment for systemic diseases)
- •Lesion >1mm below the gum line
研究组 & 干预措施
GIC filling
Intervention/treatment One group will be treated with a tooth colored filling that will be placed near the gum line (Glass Ionomer).
Placebo Comparator: GIC
Participants will have a restoration placed with GIC in the lesion near the gum line. Device: GIC Application of a tooth colored filling in the cavitated dental lesion. Other Name: Resin modified glass ionomer
干预措施: GIC (Device)
Biodentine filling
Intervention/treatment The second group will be treated with Biodentine that will be placed near the gum line.Experimental: Biodentine
Participants will have a restoration placed with Biodentine in the lesion near the gum line. Device: Biodentine Application of a white colored filling in dental lesion.
干预措施: Biodentine (Device)
结局指标
主要结局
Changes in Gingival index around Cervical Carious Lesions Restored with Calcium Silicate Based Cement (Biodentine™) Compared with Glass-Ionomer Cement;
时间窗: 6 months
Gingival health will be measured using the Loe -Silness gingival scoring Index (1963) which scores gingivitis on a numerical scale according to the following criteria: * 0 = Absence of inflammation. * 1 = Mild inflammation, slight change in color, slight edema, no bleeding on probing. * 2 = Moderate inflammation, moderate glazing, redness, bleeding on probing. * 3- Severe inflammation, marked redness and hypertrophy, ulceration, tendency to spontaneous * Gingival index will be evaluated at four sites (mesial, distal, buccal, and lingual) on each tooth
Changes in Plaque accumulation around Cervical Carious Lesions Restored with Calcium
时间窗: 6 months
detect plaque level around restorations Plaque index (PI) (Silness and Löe, 1964). Plaque levels was measured using the Plaque Index Silness and Loe in 1964 Score Criteria 0 No plaque 1. A film of plaque adhering to the free gingival margin and adjacent area of the tooth, which cannot be seen with the naked eye. But only by Using disclosing solution or by using probe. 2. Moderate accumulation of deposits within the gingival pocket, on the gingival margin and/ or adjacent tooth surface, which can be seen with the naked eye. 3. Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin. Plaque index will be evaluated at four sites (mesial, distal, buccal, and lingual) on each tooth
次要结局
- Changes in Pocket Depth around Cervical Carious Lesions Restored with Calcium(6 months)
研究者
Rola Abdelraheem Alhabashneh
Prof
Jordan University of Science and Technology