CTRI/2025/02/080376尚未招募2/3 期
Evaluation and comparison of clinical performance of composite layered polyetheretherketone (peek) full coverage crown and porcelain fused to metal (pfm) full coverage crown: a randomized controlled clinical study
Dr Dhwani Patel1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年2月25日最近更新:
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- 1. To evaluate the clinical performance of PEEK and PFM in terms of anatomical contour, marginal integrity, Restoration staining, Color match, Surface texture using the modified Ryge’s criteria.
研究概览
简要总结
| This | |
| will be an in-vivo study. 70 patients (35 per group) undergoing fixed dental | |
| prosthesis treatment will be selected for the study. The study protocol will | |
| be verbally explained and a consent form will be obtained from the patients | |
| and only those willing are going to include in the study.Complete case history shall be recorded followed | |
| by clinical examination. Then, intra oral pre-operative photographs will be | |
| taken. Then a silicone putty index will be made for standardization of the | |
| tooth preparation.Standardized teeth preparations will be done | |
| with the aid of orientation grooves on the occlusal and lingual surfaces to | |
| produce 1 mm equi-gingival deep chamfer finish line with 1-1.5 mm axial | |
| reduction with round and taper diamond bur (TR-11) and 1.5-2 mm occlusal | |
| reduction with torpedo bur (no.171). Orientation grooves on buccal surfaces to | |
| produce 1 mm equi-gingival shoulder finish line with 1-1.5 mm axial reduction | |
| with flat end taper bur (TF-12). Proximal reduction will be done with short | |
| needle diamond bur. All sharp line angles that might serve as a point for | |
| stress concentration were rounded. Finishing of shoulder margin will be done | |
| with end cutting bur (no.957). Functional cusp bevel will be performed with 45o | |
| to the long axis of the functional cusps with Round and taper bur (TR-12) bur.A retraction cord (Prime Cord – 00) will be used | |
| to allow accurate impression making. Polyvinyl siloxane (PVS) Addition silicon | |
| (Flexceed Kit) will be used for making final impression in metal stock trays. Fbrication of the PEEK and PFM crowns will be done in the laboratory. |
| All the crowns will be luted |
| adhesively with resin cement (3M RelyX Luting 2 Resin modified GIC) according |
| to manufacturer’s instructions and post operative instructions are given.Follow up sessions Recall examinations will be performed |
| to all patients after on the day of 1 week (Baseline), 3 months, 6 months. During the examination, direct clinical |
| evaluation will be performed by the outcome assessors. using modified Ryge criteria for retention, marginal |
| integrity, colour matching, marginal discoloration, secondary caries, surface |
| texture, wear-anatomic form and Periodontal status by using Russel’s |
| Periodontal Index. |
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 and Investigator Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with endodontically treated maxillary or mandibular 1st or 2nd molar.
- •Antagonist teeth should be present
- •Height abutment teeth should be approximately 3 mm on the buccal and lingual sides after preparation
- •Patients with good oral hygiene
- •Absence of parafunctional habits.
排除标准
- 未提供
结局指标
主要结局
1. To evaluate the clinical performance of PEEK and PFM in terms of anatomical contour, marginal integrity, Restoration staining, Color match, Surface texture using the modified Ryge’s criteria.
时间窗: baseline = T0 | After 3 Months = T1 | After 6 Months = T2
2. To evaluate and compare the periodontal status of PEEK and PFM using Russel’s periodontal index
时间窗: baseline = T0 | After 3 Months = T1 | After 6 Months = T2
次要结局
- To Compare the clinical performance of PEEK and PFM in terms of anatomical contour, marginal integrity, Restoration staining, Color match, Surface texture using the modified Ryge’s criteria.(2. To compare the periodontal status of PEEK and PFM using Russel’s periodontal index)
研究者
Dr Dhwani Patel
Manubhai Patel dental college and hospital
研究点 (1)
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