A COMPARATIVE ASSESSMENT OF THE SUCCESS RATE OF BONDED LITHIUM DISILICATE CERAMIC OVERLAYS AND CONVENTIONAL FULL COVERAGE CROWNS AS POST ENDODONTIC RESTORATIONS - A 1 YEAR RANDOMIZED CONTROLLED TRIAL.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Clinical evaluation will be performed using USPHS Criteria for anatomic form, marginal adaptation, colour match, marginal discolouration, caries and surface roughness.
研究概览
简要总结
BACKGROUND AND RATIONALE
The success of endodontic treatment depends not only on the endodontic procedure but also on the appropriate and timely coronal restoration of the tooth. Tooth fracture is one of the potential causes of endodontic failure. Full coverage crowns are the gold standard post endodontic restoration of choice from many years.
Full coverage crowns are dental restorations that completely cover the clinical crown of a natural tooth. They are known to be durable which increases the patient satisfaction with these restorations. Since the posterior teeth are exposed to heavy masticatory loading forces, restorations with total occlusal coverage are highly recommended in endodontically treated teeth of the area. However, the use of full coverage restorations leads to extensive tooth preparation which goes against the principle of tooth conservation.
Recently a huge growth is seen in the field of adhesive dentistry which has led to the growing trends of minimally invasive partial coverage restorations like overlays. Overlays provide major advantages like conservation of peri radicular dentin and minimal tooth preparation. Lithium disilicate is one of the most versatile metal free restorative materials, which has high esthetic potential, good mechanical properties and favorable bonding strength to dental tissues. Hence its chosen as the material of choice for the overlays.
There are several clinical studies evaluating the performance and survival of inlays, onlays, and crowns, but as per the author’s knowledge very limited studies have been found to be conducted regarding the success rate of overlays as post endodontic restorations, and regarding its comparison with conventional full coverage crowns. So the purpose of this study is to compare the success rate of bonded lithium disilicate ceramic overlays and conventional full coverage crowns as post endodontic restorations over a period of one year. Further long term studies may be required to gain a proper understanding about these restorations; nevertheless, this study is aimed to help us gain a better understanding about this field and in the formulation of a definite clinical protocol.
RESEARCH QUESTION
Are ceramic bonded overlays as successful as conventional full coverage crowns in post endodontically treated teeth ?
AIM
To evaluate the success rate of bonded lithium disilicate ceramic overlays over a 1 year period.
OBJECTIVES
To evaluate the success rate of bonded lithium disilicate ceramic overlays. To evaluate the success rate of conventional full coverage crowns. To compare the success rate of bonded lithium disilicate ceramic overlays and conventional full coverage crowns as post endodontic restorations.
NULL HYPOTHESIS
There is no difference in the success rate of bonded lithium disilicate ceramic overlays and conventional full coverage crowns as post endodontic restorations.
STUDY DESIGN
Experimental study, randomized controlled trial.
SAMPLING METHOD
Simple random sampling method by tossing a coin method of randomization.
PROCEDURE
The study population will be selected from the out patients visiting the department of prosthodontics and department of endodontics, Educare institute of dental sciences, Malappuram. The study group will be selected randomly based on the inclusion and exclusion criteria. Prospective patients fulfilling the criteria will be screened clinically after informing them about the study and after gaining informed consent from them. They will then be randomly allocated into two groups, experimental and control group by tossing a coin method of randomization. The calculated sample size is 70, with each group consisting of 35 samples. Group 1 or experimental group will comprise of patients with bonded lithium disilicate ceramic overlays (35 overlays) and group 2 or control group will comprise of patients with PFM full coverage crowns (35 full coverage crowns). Tooth preparations will be done following the principles of tooth preparation.
FOLLOW UP CRITERIA
Clinical evaluation will be performed at every 6 months using modified united states public health service (USPHS) criteria. Along with clinical evaluation of certain parameters such as mode of fracture and debonding of restoration will be carried out.
ETHICAL CONSIDERATION
Patients will be briefly informed about the procedure prior to the study. Patients will be given written consent form in English and Malayalam regarding the procedures. Written consent in English and Malayalam will be taken from the patient prior to the procedure. No special charges will be levied from the patient. No reward or compensation will be granted to anyone particularly in this study.
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
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy patients in 20-60 age group having most of the dentition.
- •Patients having at least 3 walls of intact tooth structure after endodontic treatment.
- •Endodontically treated teeth with adequate bone support.
- •Patients with good oral hygiene and plaque control.
- •Patients with healthy gingival and periodontal status, having probing depth less than 4 mm in all teeth.
- •Patients with class 1 occlusion.
排除标准
- •Patients with bruxism and other parafunctional habits.
- •Patients having loss of teeth in quadrant opposing the restoration.
- •Patients with systemic diseases which might hinder the outcome of the study.
结局指标
主要结局
Clinical evaluation will be performed using USPHS Criteria for anatomic form, marginal adaptation, colour match, marginal discolouration, caries and surface roughness.
时间窗: Clinical evaluation will be performed using USPHS Criteria for anatomic form, marginal adaptation, colour match, marginal discolouration, caries and surface roughness at baseline, 6 months, 12 months.
次要结局
- Clinical evaluation of certain parameters such as mode of fracture & debonding of restoration will be carried out.(Clinical evaluation of certain parameters such as mode of fracture & debonding of restoration will be carried out at baseline, 6 months, 12 months.)
研究者
VARADA M
EDUCARE INSTITUTE OF DENTAL SCIENCES, AFFILIATED TO KERALA UNIVERSITY OF HEALTH SCIENCES, RECOGNISED BY DENTAL COUNCIL OF INDIA AND DEPARTMENT OF HEALTH AND FAMILY WELFARE, GOVERNMENT OF INDIA, NAAC ACCREDITED