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临床试验/NCT06096753
NCT06096753尚未招募不适用

Comparative Evaluation of Gnathological Function With Bruxoff® in Edentulous Patients With Immediate Load Full-arch Restorations (Columbus Bridge ProtocolTM) vs Toothed Patients: a Pilot Study

University of Turin, Italy0 个研究点目标入组 20 人开始时间: 2023年11月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
20
主要终点
Masseter contractions

研究概览

简要总结

This study aims to compare the gnathological function of edentulous patient rehabilitated according to the full-arch method (Columbus Bridge Protocol™) with immediate loading with that of dentate patients, through at-home night-time monitoring with Bruxoff® device.

详细描述

Dental implants are now widely used in dentistry for the rehabilitation of partially or totally edentulous arches. These devices have shown excellent clinical success and are considered a reliable long-term treatment(1). In particular, the rehabilitation of the complete arch with immediate loading supported by maxillary implants has now become a safe and reliable procedure capable of rehabilitating the patient with residual or totally edentulous teeth. A fixed prosthesis supported by implants performed according to an immediate loading protocol represents a valid therapeutic option for the rehabilitation of totally edentulous patients, both from the point of view of patient satisfaction and masticatory performance(2,3,4).

Among the various protocols available in the literature, the one called Columbus Bridge Protocol™, developed by the prosthetic school of the University of Genoa, consists in the rehabilitation of one or both jaws with the insertion of a variable number of 4 to 6 dental implants followed by immediate loading(5). This rehabilitation has been documented to be a reliable implant-prosthetic solution in terms of survival and implant success in the medium and long term(2,6). However, considering the current scientific evidence, there is a lack of information relating to possible alterations in muscle activity following this implant-prosthetic rehabilitation.

For the evaluation of EMG activity of the stomatognathic system, the School of Turin has, for a decade now, tested and validated the use of Bruxoff® portable device for the evaluation of nocturnal bruxism, demonstrating a sensitivity and specificity of 91.6 % and 84.6% respectively (7,8).

Bruxoff® is a portable holter that uses 3 recording channels: 2 for recording the surface electromyographic signals (sEMG) of the two masseter muscles with concentric electrodes positioned on the two muscles (CoDe®: Concentric Detection, Spes Medica, Battipaglia, Italy), and one for heart rate detection (ECG) with a strap incorporating three surface electrodes positioned on the left side of the chest (7,13).

Patients who have been rehabilitated with a full-arch for at least 6 months at the Dental School of Turin and subjects waiting for implant-prosthetic rehabilitation of intercalated edentulism (i.e. single-tooth gap) will be involved.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Willingness to participate in the study
  • Age >18 years
  • Good general state of health
  • Absence of clinical symptoms of bruxism, i.e. sore masticatory muscles(10,11)
  • Good level of oral hygiene (assessed with FMPS <25%)
  • FMBS <25%
  • Exclusion Criteria (9):
  • Age <18 years
  • Presence of severe psychiatric pathologies
  • Presence of neuromuscular diseases/ severe neurodegenerative diseases
  • Presence of diabetes or other metabolic diseases
  • Pharmacological treatment with drugs that compromise the neuromuscular system
  • Pharmacological treatment with antipsychotic drugs
  • Presence of severe chronic diseases
  • Cognitive disability
  • Acute inflammation
  • Presence of an oncological condition
  • Smoking (>10 cigarettes per day) Individuals with alcohol or drug addiction will be excluded. Subjects will also be asked not to consume caffeine, alcohol and tobacco in the 6 hours before starting the night recording with Bruxoff®(12).
  • Patients with implants affected by peri-implant pathology will be excluded from the Test Group.(15) Subjects suffering from periodontal disease (Stage III/IV Grade B/C) will be excluded from the Control Group (16).

排除标准

  • 未提供

结局指标

主要结局

Masseter contractions

时间窗: Night 1, Night 2, Night 3

Number and type of masseter contractions (tonic/phasic/mixed)

Heart rate

时间窗: Night 1, Night 2, Night 3

Average heart rate

Bruxism episodes

时间窗: Night 1, Night 2, Night 3

Number of possible episodes of nocturnal bruxism in total and per hour of sleep

次要结局

未报告次要终点

研究者

发起方
University of Turin, Italy
申办方类型
Other
责任方
Principal Investigator
主要研究者

Francesco Pera

prof.

University of Turin, Italy

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