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Evaluation of Patient Satisfaction Using Autogenous Inlay (Sandwich) Eminoplasty Versus Patient Specific Poly Ether-ether Ketone (PEEK) Onlay Implant

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03994692
Recruitment Status : Not yet recruiting
First Posted : June 21, 2019
Last Update Posted : June 21, 2019
Sponsor:
Collaborator:
El-Galaa Military Medical Complex
Information provided by (Responsible Party):
mustafa gamal abdel kawy, El-Galaa Military Medical Complex

Brief Summary:

Aim of the study:

The aim is minimize morbidity in treatment of TMJ dislocation. Hypothesis: Alternate hypothesis that treatment tmj dislocation with PEEK eminoplasty will be more efficient than using autogenous inlay technique

PICO:

Problem (P): patients with un pleasant painful dislocated tmj Intervention (I): eminoplasty with patient specific poly ether-ether ketone (PEEK) onlay implant Control Group (C): autogenous inlay (sandwich) eminoplasty Outcome (O): patient Satisfaction, dislocation treatment (normal range of mouth opening), less morbidity.


Condition or disease Intervention/treatment Phase
Mandibular Dislocation Device: PEEK eminoplasty Procedure: autogenous onlay grafting eminoplasty Not Applicable

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
  • randomized control trial
  • trials will be carried out in hospital of oral & maxillofacial department at faculty of oral and dental medicine of Cairo university
  • equal randomization participants with equal probabilities for intervention
  • positive controlled , both groups receiving treatment
  • parallel group study , each group of patient receive single treatment simultaneously
Masking: None (Open Label)
Masking Description: because the two intervention in this trial are clearly different and easily recognized by participant and investigator , neither investigators nor participant can be blinded
Primary Purpose: Treatment
Official Title: Evaluation of Patient Satisfaction Using Autogenous Inlay (Sandwich) Eminoplasty Versus Patient Specific Poly Ether-ether Ketone (PEEK) Onlay Implant in Treatment of Chronic Condylar Dislocation A Randomized Control Trial
Estimated Study Start Date : June 20, 2019
Estimated Primary Completion Date : July 20, 2020
Estimated Study Completion Date : March 20, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dislocations

Arm Intervention/treatment
Experimental: PEEK eminoplasty

CT scan with bony window for facial bones and DICOM files on CD .then, Using cad cam software (mimics 15) , the virtual design and surgery will be done.

under general anathesia The TMJ will be exposed using the endural incision line and the articular eminence will be identified then blunt dissection so that the front wall of the articular capsule can be exposed completely.

  • The patient specific PEEK eminence will be inserted and secured with two to three pre-planed screws .
  • Functional mandibular movements were reproduced to confirm absence of subluxation and then closure
Device: PEEK eminoplasty
making obstacle at eminence using patient specefic PEEK device
Other Name: poly ether - ether ketone

Active Comparator: autogenous onlay grafting eminoplasty

under general anesthesia , chin graft was taken Layered Endural approach to TMJ making wedge in eminence by mallet & chisel (green stick fracture), then wedging piece of chin graft to increase the height of the eminence creating an obstacle to treat dislocation by manipulation of patient mandible intra operative.

- Functional mandibular movements were reproduced to confirm absence of subluxation then closure

Procedure: autogenous onlay grafting eminoplasty
making obstacle at eminence using chin graft
Other Name: grafting eminoplasty




Primary Outcome Measures :
  1. Patient satisfaction: Question [ Time Frame: up to 4 month after operation ]
    Questioning the patient about if there is any dislocation or any limitation to mandibular movement


Secondary Outcome Measures :
  1. Maximal Incisal Opening [ Time Frame: follow up for 4 month ]
    measured with Caliper

  2. Intra operative time [ Time Frame: during operation ]
    measured with time calculation

  3. Post operative pain: VAS [ Time Frame: follow up for 2 weeks up to 4 month ]
    measured with visual analogue scale



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   22 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • - Patient with recurrent dislocation with maximum inter incisal opening over 55mm
  • Long-standing dislocation of the TMJ involving both fixation for more than 3 weeks and the failure of manual reduction
  • Failure of conservative strategies such as orientation to self-limit jaw movement and the use of a chin-cap or bandage
  • Both sexes
  • Age between 18 and 48 years.
  • Highly motivated patients.

Exclusion Criteria:

  • Post-menopausal females with osteoporosis
  • Patient with uncontrolled systemic disease
  • pregnancy
  • psychological disorders, drug or alcohol dependency
  • Known allergies or sensitivities to dental materials, including PEEK, Titanium or general anesthetic agents
  • Inability to return for follow up visits.
  • Refusal of participation from the patient

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03994692


Contacts
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Contact: mustafa gamal abdel kawy, B.D.S 01004519806 mustafa.gamal@dentistry.cu.edu.eg
Contact: mustafa gamal abdel kawy, B.D.S 01021287358 hero0105590840@hotmail.com

Sponsors and Collaborators
Cairo University
El-Galaa Military Medical Complex
Investigators
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Study Director: mohamed mounir, Phd faculty of oral and dental medecine cairo university
Publications:
1-Mayer L. Recurrent dislocation of the jaw. J Bone Joint Surg1933;15:22Y25 2- Van der Kwast WA. Surgical management of bilateral habitual luxation of the mandible. Int J Oral Surg 1978;7:329Y332 3- Gosserez M, Dautrey J. Osteoplastic bearing for the treatment of temporomandibular luxations. In: Oral Surgery Transactions of 2nd Congress of Int Assoc Oral Surg Copenhagen. 1967:261Y264 4- Lindemann A. Die chirurgische behandlung der erkrankungen des kiefergelenkes. Z Stoma 1925;23:395Y 406 5- Iizuka T, HNdaka H, Murakami K, et al. Chronic recurrent anterior luxation of the mandible. Int J Oral Maxillofac Surg 1988; 17:170Y172

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Responsible Party: mustafa gamal abdel kawy, resident of oral & maxillofacial surgery department, El-Galaa Military Medical Complex
ClinicalTrials.gov Identifier: NCT03994692    
Other Study ID Numbers: omfs 3-3-3
First Posted: June 21, 2019    Key Record Dates
Last Update Posted: June 21, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by mustafa gamal abdel kawy, El-Galaa Military Medical Complex:
PEEK eminoplasty ,autogenous inlay (sandwich) eminoplasty
Additional relevant MeSH terms:
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Joint Dislocations
Joint Diseases
Musculoskeletal Diseases
Wounds and Injuries
Ether
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs