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临床试验/CTRI/2026/02/104248
CTRI/2026/02/104248尚未招募Phase 3 4

BITE FORCE AND FUNCTIONAL CHANGES OF PRIMARY MOLARS RESTORED WITH PREFORMED STAINLESS-STEEL CROWNS AND BIOFLX CROWNS USING DIGITAL OCCLUSAL ANALYSIS: A CLINICAL STUDY

Dr Anjana K S1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2026年8月10日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
45
试验地点
1

研究概览

简要总结

A total of 45 primary molars from children aged 6 to 9 years with extensive dental caries requiring full coverage restorations by using preformed crowns will be enrolled.Teeth will be allocated equally among following three groups n equals 15 each.

Group 1 Tooth preparation and placement of Stainless steel crowns SSC.

Group 2 Placement of Stainless steel crowns using Hall technique.

Group 3 Tooth preparation and placement of Bioflx crowns.

Evaluation of Bite force and functional changes of full coverage crowns

Determination of occlusal load in maximum intercuspal position using T Scan III

Baseline Pretreatment evaluation T0

Children selected for the present study will be requested to bite on back teeth together several times from a 15 to 20 mm mandibular opening and the bite force will be checked to confirm repeatability on the primary molar Four consecutive recordings of the patients maximum intercuspal position will be taken A single examiner will record all the four readings of bite at maximum intercuspal position for each subject using T scan.

Post treatment Immediately after the placement of full coverage crown T1

After the placement of the full coverage crown on the selected molar occlusal load at maximum intercuspal position will be recorded using T Scan III as mentioned in the baseline evaluation T0 and the readings are recorded for further evaluation.

Post treatment measurements after one week T2

After one week follow up the maximum intercuspal position will be measured as mentioned in the baseline evaluation T0 and readings are recorded for further evaluation.

Post treatment measurements after one month T3

After one month follow up the maximum intercuspal position will be measured and recorded using T scan as mentioned in the baseline evaluation T0.

The outcomes assessed at T0 T1 T2 and T3 will be analyzed and compared statistically to determine changes in bite strength and functional occlusion over the follow up period.

研究设计

研究类型
Interventional

入排标准

年龄范围
6.00 Year(s) 至 9.00 Year(s)(—)
性别
All

入选标准

  • 1.Children in good general health, aged between 6 to 9 years from either gender.
  • 2.Presence of intact dentition with normal molar relation requiring unilateral placement of full coverage restoration in the treatment plan.
  • 3.Hall technique crowns primary molar caries involving dentine, but not extending into the pulp with detectable cervical constriction and at least two surfaces and a part of the occlusal surface is left intact.
  • 4.Conventional Stainless-steel crowns and Bioflx crowns Primary molar having multi-surface caries.
  • Primary molar with wide proximal lesion.
  • Primary molar requiring pulp therapy.
  • 5.No gingival inflammation, no periodontal diseases, no mobility of teeth, or apparent facial asymmetry that could affect recordings.

排除标准

  • 1.Children with special health care conditions.
  • 2.Patients with TMJ disorders.
  • 3.Children with malocclusion.
  • 4.Children with developmental anomalies.
  • 5.Children with parafunctional habits,e.g bruxism.

研究者

发起方
Dr Anjana K S
申办方类型
Other [Self funded]
责任方
Principal Investigator
主要研究者

Dr Anjana K S

Rajarajeswari Dental College and Hospital bangalore

研究点 (1)

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