PMID- 34951603
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220223
IS  - 1929-0748 (Print)
IS  - 1929-0748 (Electronic)
IS  - 1929-0748 (Linking)
VI  - 10
IP  - 12
DP  - 2021 Dec 24
TI  - Effects of Prosthetic Rehabilitation on Temporomandibular Disorders: Protocol for 
      a Randomized Controlled Trial.
PG  - e33104
LID - 10.2196/33104 [doi]
LID - e33104
AB  - BACKGROUND: Loss of teeth or occlusal imbalance is one of the proposed dental 
      risk factors for temporomandibular disorders (TMDs). Losing some non-free-end 
      teeth cause the original occluding tooth/teeth to supraerupt from the original 
      upright position and causes neighboring tooth/teeth to shift in an angle, causing 
      biomechanical imbalance on the mandible. Based on these sequelae, rehabilitation 
      of missing teeth is the first step in managing TMD in edentulous patients. Even 
      though the prevalence of TMD in association with edentulism and in rehabilitated 
      patients has been increasing, proper guidelines for the management of such cases 
      have not been established. This study describes the protocol to analyze the 
      effect of prosthetic rehabilitation on patients with TMD. OBJECTIVE: This study 
      aims to determine the effectiveness of prosthetic rehabilitation in the reduction 
      of pain in edentulous patients with TMD and to determine the effect of the span 
      of edentulism, the number of quadrants involved, pathological migration, the type 
      of Kennedy classification, and the prosthetic status on temporomandibular joint 
      dysfunction signs and symptoms. METHODS: In this randomized controlled trial, 300 
      patients diagnosed with TMD will be grouped into one of the three interventional 
      groups based on the type of their edentulous state. The interventional groups are 
      (1) partially edentulous arch: Kennedy Class I and II (prosthetic rehabilitation 
      without splint); (2) partially edentulous arch: Kennedy Class III and IV 
      (prosthetic rehabilitation with a splint); and (3) completely edentulous arches 
      (prosthetic rehabilitation without splint). All three of the mentioned 
      interventional groups have corresponding control groups that will receive 
      symptomatic treatment and comprehensive counseling. The measured primary outcomes 
      are pain and electromyogram, and the secondary outcomes include pain drawing, 
      Graded Chronic Pain Scale, Jaw Functional Limitation Scale, Oral Behaviours 
      Checklist, depression, physical symptoms, and anxiety. The outcome measurements 
      will be recorded at baseline and at the end of 24 hours, 7 days, 28 days, and 3 
      months. RESULTS: Ethical approval was obtained from the Institutional Review 
      Board of Amrita Institute of Medical Sciences, Kochi, India. Study participants' 
      recruitment began in May 2021 and is expected to conclude in March 2023. This 
      clinical trial protocol was developed based on the SPIRIT (Standard Protocol 
      Items: Recommendations for Interventional Trials) 2013 Statement. CONCLUSIONS: 
      The purpose of this study is to gather data on prosthetic rehabilitation as a 
      treatment for TMD. Obtaining this goal will aid in the development of 
      evidence-based therapy protocols for prosthetic rehabilitation in TMD management. 
      TRIAL REGISTRATION: Clinical Trials Registry - India CTRI/2020/06/026169; 
      http://ctri.nic.in/Clinicaltrials/pdf_generate.php?trialid=42381. INTERNATIONAL 
      REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/33104.
CI  - (c)Saranya Sreekumar, Chandrashekar Janakiram, Anil Mathew. Originally published in 
      JMIR Research Protocols (https://www.researchprotocols.org), 24.12.2021.
FAU - Sreekumar, Saranya
AU  - Sreekumar S
AUID- ORCID: 0000-0001-7648-7407
AD  - Department of Prosthodontics and Implantology, Amrita School of Dentistry, Amrita 
      Vishwa Vidyapeetham, Kerala, India.
FAU - Janakiram, Chandrashekar
AU  - Janakiram C
AUID- ORCID: 0000-0003-1907-8708
AD  - Department of Prosthodontics and Implantology, Amrita School of Dentistry, Amrita 
      Vishwa Vidyapeetham, Kerala, India.
FAU - Mathew, Anil
AU  - Mathew A
AUID- ORCID: 0000-0002-8069-9813
AD  - Department of Prosthodontics and Implantology, Amrita School of Dentistry, Amrita 
      Vishwa Vidyapeetham, Kerala, India.
LA  - eng
PT  - Journal Article
DEP - 20211224
PL  - Canada
TA  - JMIR Res Protoc
JT  - JMIR research protocols
JID - 101599504
PMC - PMC8742205
OTO - NOTNLM
OT  - TMD
OT  - joint pain
OT  - orofacial pain
OT  - prosthesis, edentulism
OT  - prosthetic rehabilitation
OT  - temporomandibular disorder
COIS- Conflicts of Interest: None declared.
EDAT- 2021/12/25 06:00
MHDA- 2021/12/25 06:01
PMCR- 2021/12/24
CRDT- 2021/12/24 12:08
PHST- 2021/09/02 00:00 [received]
PHST- 2021/11/10 00:00 [accepted]
PHST- 2021/10/28 00:00 [revised]
PHST- 2021/12/24 12:08 [entrez]
PHST- 2021/12/25 06:00 [pubmed]
PHST- 2021/12/25 06:01 [medline]
PHST- 2021/12/24 00:00 [pmc-release]
AID - v10i12e33104 [pii]
AID - 10.2196/33104 [doi]
PST - epublish
SO  - JMIR Res Protoc. 2021 Dec 24;10(12):e33104. doi: 10.2196/33104.