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An evaluation of surface electromyography and masticatory performance in patients wearing thermoplastic oral appliance: a randomized clinical trial

An evaluation of surface electromyography and masticatory performance in patients wearing thermoplastic oral appliance: a randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
TCTR
Registry ID
TCTR20190416001
Enrollment
Unknown
Registered
2019-04-16
Start date
2019-01-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The particular health condition(s) or problem(s) being prevented. Electromyography Masticatory muscle activity Clear thermoplastic retainer Wrap&#45

Interventions

All thermoform appliances are manufactured&#44
under standardized laboratory conditions and following the manufacturer’s instructions&#44
using a dental laboratory thermoforming machine (BIOSTAR®&#45
Scheu&#45
Dental GmbH&#44
Germany). The thermoplastic appliances are made from 0.75&#45
mm thick Essix ACE plastic foil (ACE&#44
Raintree Essix&#44
Glenroe). ,The wrap&#45
around retainers had the acrylate base placed orally&#44
and the labial archwire was made from round&#44
0.8&#45
mm diameter&#44
stainless steel wire (Dentaurum&#44
Ispringen&#44
Germany). The labial arches surrounded all erupted teeth including the second molars and formed a U&#45
shaped loop between the canines and first premolars.
Experimental Device,Active Comparator Device
thermoplastic vacuum&#45
formed appliance group,wrap&#45

Sponsors

Department of Orthodontics, Faculty of Dentistry, Chulalongkorn University
Lead Sponsor
Department of Physiology&#44
Collaborator
Faculty of Dentistry&#44
Collaborator
Chulalongkorn University
Collaborator

Eligibility

Sex/Gender
All
Age
14 Years to 40 Years

Inclusion criteria

Inclusion criteria: - All participants have a natural dentition with no missing teeth except for the third molars - All participants are dentate with a Class I occlusion, overjet and overbite less than 3 mm. - All participants had no edentulous area, no significant facial deformity or symptoms of cranio-mandibular disorders, and no temporomandibular symptoms based on the assessment protocol of Schiffman, et al.18 (2016) - The participants had previous orthodontic treatment by either extraction or non-extraction, and have to wear removable retainers for maintain the occlusion.

Exclusion criteria

Exclusion criteria: - Systemic diseases that may affect activities of the masticatory muscles. - Medications, such as muscle relaxants, that may affect muscle function

Design outcomes

Primary

MeasureTime frame
Muscle ability Pre-treatment (T0), immediate wearing the appliances (T1), after 3-month (T2) and after 6 month (T3) Surface electromyographic measurement,Masticatory performance Pre-treatment (T0), immediate wearing the appliances (T1), after 3-month (T2) and after 6 month (T3) Chewing efficiency measurement

Secondary

MeasureTime frame
Subjective evaluation of masticatory ability Pre-treatment (T0), immediate wearing the appliances (T1), after 3-month (T2) and after 6 month (T3) Food Intake Ability Index assessment,oral health-related quality of life After 6-month follow up visit oral health-related quality of life assessment

Contacts

Public ContactRungtiwa Jirawiwatsaree

Faculty of Dentistry, Chulalongkorn University

Mue.jirawiwat@gmail.com090-9853266

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026