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
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)
