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临床试验/CTRI/2025/03/082289
CTRI/2025/03/082289尚未招募3 期

Comparative evaluation of the gingival displacement by conventional and customized polytetrafluoroethylene (PTFE) retraction cord -A split mouth clinical trial

Dr Surabhi S1 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2025年5月5日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
13
试验地点
1
主要终点
To evaluate and compare the amount of gingival displacement produced by conventional and customized polytetrafluorethylene (PTFE) retraction cord.

研究概览

简要总结

Infixed restoration, gingival displacement plays an important role in excellentreproduction of marginal details. Gingival retraction involves deflection ofgingival tissues away from the tooth to expose the cervical part or margins ofprepared tooth. A sulcular width of 0.15 to 0.20 mm is needed for accurateimpression. If the sulcus width is less than this value, impression material issubjected to rupture and deformation, with reduced marginal accuracy. Aninappropriate gingival displacement technique can be a primary factor indefective recording of marginal details. Various methods for gingivalretraction are mechanical, mechanochemical, electrosurgery, rotary gingivalcurettage, laser etc. Following are fewacceptable criteria during gingival displacement:(1) Minimum of 0.22 mm spacelaterally and vertically should be present between finish line and gingiva forimpression material to record without distortion. (2) for accurate trimming ofrecovered die additionally small amount of impression material should flowbeyond prepared margins, (3) especially when elastomeric impression material,gingival fluid seepage and hemorrhage should be considered (4) protection fromirreversible hard and soft tissue damages, (5) protection against dangeroussystemic effects. Mechanical method ofgingival retraction uses both impregnated and non-impregnated retraction cords.Common disadvantages including damage to junctional epithelium, post-retractioninflammation and gingival recession, bleeding and patient discomfort duringprocedure and technique sensitive. Various other techniqueshave been introduced to overcome all these disadvantages thereby replacing theuse of retraction cord which includes retraction paste, gels, foams, lasers andsurgery. While researches still conclude use of retraction cord as goldstandard due to its cost-effectiveness and reliability and excellentdisplaceability of gingiva.Polytetrafluoroethylene(PTFE) tape, a synthetic fluoropolymer. Commercially referred as Plumber’s tapeor Teflon is heat stable, nonadherent with low co-efficiency of friction inertand non-reactive to oral fluids as well as other acids used in dentistry. widelyused in the field of clinical dentistry for isolation and in guided boneregeneration. Use of PTFE tape for gingival retraction is limited. Recent studyhas shown that conventional gingival retraction cord and PTFE cord incorporatedwith aluminium chloride displayed similar outcomes of ease of placement andbleeding after cord removal. This study will befocusing on a new technique to standardize the use of PTFE tape for gingivalretraction in comparison with conventional retraction cord on an unpreparedtooth.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Not Applicable

入排标准

年龄范围
30.00 Year(s) 至 40.00 Year(s)(—)
性别
All

入选标准

  • Patients with healthy mandibular 2nd premolar withboth sides teeth should have nearly similar size and anatomy with probing depth less than 3mm.

排除标准

  • 1.Bleeding on probing.
  • 2.High plaque index.
  • 3.Gingival recession.
  • 4.Developmental anomalies or anatomical variations.
  • 5.Pre-existing systemic conditions.
  • 6.Thin gingival biotype.

结局指标

主要结局

To evaluate and compare the amount of gingival displacement produced by conventional and customized polytetrafluorethylene (PTFE) retraction cord.

时间窗: Baseline, 2 weeks

次要结局

  • 1.To evaluate the amount of gingival displacement produced by conventional retraction cord size 000.(Baseline, 2 weeks)
  • 2.To evaluate the amount of gingival displacement produced by customized polytetrafluorethylene (PTFE) retraction cord.(Baseline, 2 weeks)

研究者

发起方
Dr Surabhi S
申办方类型
Other [self]

研究点 (1)

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