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

NCT03994692 | Unknown DMC

• 1 other identifier: omfs 3-3-3
• Study Type: interventional
• Target: 7
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Mandibular Dislocation

Keywords

PEEK eminoplasty ,autogenous inlay (sandwich) eminoplasty

Outcome Measures

Primary Outcomes (1)

• Patient satisfaction: Question

  Questioning the patient about if there is any dislocation or any limitation to mandibular movement

  up to 4 month after operation

Secondary Outcomes (3)

• Maximal Incisal Opening

  follow up for 4 month

• Intra operative time

  during operation

• Post operative pain: VAS

  follow up for 2 weeks up to 4 month

Study Arms (2)

PEEK eminoplasty

EXPERIMENTAL

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

autogenous onlay grafting eminoplasty

ACTIVE COMPARATOR

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

Interventions

PEEK eminoplasty DEVICE

making obstacle at eminence using patient specefic PEEK device

Also known as: poly ether - ether ketone

PEEK eminoplasty

autogenous onlay grafting eminoplasty PROCEDURE

making obstacle at eminence using chin graft

Also known as: grafting eminoplasty

autogenous onlay grafting eminoplasty

Eligibility Criteria

• Age: 22 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \- 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead
• El-Galaa Military Medical Complex: collaborator

Related Publications (1)

• 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

  BACKGROUND

Study Officials

• mohamed mounir, Phd

  faculty of oral and dental medecine cairo university

  STUDY DIRECTOR

Central Study Contacts

mustafa gamal abdel kawy, B.D.S

CONTACT

01004519806; mustafa.gamal@dentistry.cu.edu.eg

mustafa gamal abdel kawy, B.D.S

CONTACT

01021287358; hero0105590840@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: because the two intervention in this trial are clearly different and easily recognized by participant and investigator , neither investigators nor participant can be blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident of oral & maxillofacial surgery department

Model Details: * 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

Study Record Dates

• First Submitted: June 19, 2019
• First Posted: June 21, 2019
• Study Start: June 20, 2019
• Primary Completion: July 20, 2020
• Study Completion: March 20, 2021
• Last Updated: June 21, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share