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临床试验/CTRI/2024/04/065072
CTRI/2024/04/065072已完成不适用

Comparative Evaluation of Retention and Oral Health Quality of Life in Dentures Fabricated with Conventional Impression Technique and Transcutaneous Electric Nerve Stimulation: A Prospective Clinical study

Manav Rachna Dental College, MRIIRS1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年4月16日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
1.To evaluate and compare retention in dentures fabricated with conventional impression method and TENS in completely edentulous patients.

研究概览

简要总结

Aim:The aim of the present study was to comparatively evaluate the retention ofcomplete dentures and oral health-related quality of life (OHRQoL) of patientswith conventional and bioelectric impressions or transcutaneous electric nervestimulation (TENS).

Materials and Methods: A total of thirty (n=30) completely edentulouspatients were randomly distributed into two groups: Group-C (n=15)(Conventional) and Group-T (n=15) (bioelectric) according to consort guidelines.In Group C, border molding was performed using the manual manipulation ofborders, and the final impression was made using zinc-oxide eugenol. In Group T,border molding and final impression were performed with the TENS application. Dentureswere fabricated, and retention was evaluated with a digital gauge. OHRQoL was assessedat the time of insertion and after three months of follow-up using the OralHealth Impact Profile Edentulous in Hindi (OHIP-Edent-H) questionnaire. Atwo-way ANOVA test was used for the significance level (P<0.05). Studentt-test was used for intergroup comparison, and paired t-test was used forintragroup comparison of OHRQoL.

Results: There was no significantdifference in the retention of maxillary and mandibular dentures fabricatedwith both techniques (P=0.283, P=0.662). Although, OHRQoLincreased significantly in both groups at follow-up (P=.001). However,at follow-up, the Functional Limitation (FL) domain was significantly better inthe conventional group.

Conclusions. Although, there was no significant difference inretention and OHRQoL between both groups. However, to reach a conclusiveresult, more clinical trials with large samples and longer follow-ups arerequired.

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
45.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Completely edentulous patients in need of dentures No need of pre-prosthetic surgery Patients with healed residual ridges patients ready for follow-up.

排除标准

  • Patients with ridge defects Patients with any systemic disease which contraindicates electrode placement e.g. cardiac pacemaker etc.
  • Patients with poor neuromuscular control, temporomandibular joint pain, Psycholgical disorder.
  • Patients with single complete denture.

结局指标

主要结局

1.To evaluate and compare retention in dentures fabricated with conventional impression method and TENS in completely edentulous patients.

时间窗: at baseline (at the time of insertion) for both dentures

次要结局

  • 2.To measure and compare OHI-Edent in dentures fabricated with conventional impression method and TENS in completely edentulous patients.(At the time of insertion, 3 months after insertion)

研究者

发起方
Manav Rachna Dental College, MRIIRS
申办方类型
Research institution

研究点 (1)

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