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

June 20, 2019 updated by: mustafa gamal abdel kawy, Cairo University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

8. Trial design: Type: Parallel, two arm, randomized clinical trial. Allocation ratio: 1:1 Superiority framework

III. Methods A) Participants, interventions & outcomes 9. Study settings: Diagnosis in outpatient clinic of Oral and Maxillofacial surgery at the faculty of dentistry, Cairo University, Urban area, Cairo Governorate, Egypt.

The surgery will be in O.R rooms or in the outpatient clinic of the same faculty.

11. Interventions

Control Group:

Patient preparation The operation can be performed under general anesthesia. mental nerve blocks will be given and infiltration for hemostasis.

After allowing adequate time for vasoconstrictor effects to take place, the incision is initiated in a layered approach through the labial mucosa and is continued through the mentalis muscles and periosteum.

Exposure of the symphyseal bone is undertaken using periosteal elevators and the mental nerves are visualized bilaterally.

The roots of the incisors and canines should be localized and bone cuts should be made at least 5 mm inferior to the root apices.

The roots of canines can impede the operation and limit the size of graft. Similarly, the surgeon should stay at least 5 mm away from the inferior border of the symphysis and the mental foramina.

Bone cuts can be made with a bur or reciprocating saw under copious saline irrigation. When the desired bone cuts have been completed, thin straight or curved osteotomes are then used to deliver the graft Hemostasis can be achieved using resorbable hemostatic agents or fibrin glue. Long-lasting local anesthetic, e.g. bupivacaine, can be applied to the area to achieve longer analgesia.

The wound closure is done in two layers with a resorbable suture for the muscle layer and fast-resorbing suture for the mucosa.

Flexible skin tape can be used on the chin for 3-5 days to reduce swelling and prevent wound dehiscence.

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 and checked for interference and any required adjustments made.
  • A multilayer closure of the incisions will be accomplished using Vicryl sutures (88).

Intervention group ; CT scan will be done with the following criteria;

bony window for facial bones, axial cuts, minimal slice thickness, minimal intervals between the cuts, guantry tilt equals zero and finally DICOM files on CD .then, Using cad cam software (mimics 15) , the virtual design and surgery will be done.

Patient Preparation;

  • All surgeries will be performed under general anaesthesia (naso-endotracheal intubation)
  • Then the entire periarticular region and overlying skin will be infiltrated by 2% lidocaine (20 ml lidocaine + adrenalin 1%) via a 25 gauge needle as an additional anaesthesia.
  • Benzyl penicillin 2 MIU in combination with dicloxacillin 1 g will be administered intravenously as prophylactic antibiotics.
  • A line is drawn between the lateral eyebrow and tragus. The articular fossa and condylar head is located 10 mm anterior to the tragus and 2-5 mm below this line.
  • The temporofacial branch has relatively a constant course and vector being on a line located 0.5 cm below the tragus of the ear, in the direction of the eyebrow and passing 1.5 cm above the lateral eyebrow. Just anterior to the condylar head where the articular eminence will be identified by palpation and marked.

The TMJ will be exposed using the endural incision line and the articular eminence will be identified

  • To locate the articular eminence precisely, tissue must be exposed layer by layer until the articular eminence is located. Then, a tunnel will be formed using blunt dissection so that the front wall of the articular capsule can be exposed completely.(89-90-91 )
  • 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 checked for interference and any required adjustments made.
  • A multilayer closure of the incisions will be accomplished using Vicryl sutures.

For both groups masseter muscle scarification through intra oral approach will be done with post-operative intermaxillary fixation using ivy loops

Post-operative instructions:

According to Oral Maxillo-fac Surg Clin North Am (Quinn PD, 2000):

The following postoperative protocol will be used for patients of both groups:

  • Broad-spectrum antibiotics (penicillin V 1 g, or clindamycin 600 mg) and non-steroidal anti-inflammatory drugs (NSAIDS) will be prescribed for 1 week.
  • The patients will be told to stay on a soft diet for 5 days and encouraged to resume a normal diet as soon as possible.
  • Physiotherapy will start on postoperative day 1, and patients will be encouraged to increase the exercise program as soon as possible.
  • Patients will be advised to continue physiotherapy for at least 1 year and possibly longer.
  • Cone Beam CT (CBCT) imaging will be performed at the first follow-up visit in order to visualize the position of the patient specific titanium eminence, as well as the position of the retention screws and their relationships to the surrounding vital structures following surgery.

Visit: (every month till 4 month after operation) For group I: Regular follow up with measuring maximum inter incisal distance with a caliper , check normal mandibular movement & other problems like pain ,discomfort & swelling For group II: Regular follow up with measuring maximum inter incisal distance with a caliper , check normal mandibular movement & other problems like pain ,discomfort & swelling

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
7

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

22 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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 Names:
  • grafting eminoplasty

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
up to 4 month after operation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Maximal Incisal Opening
Time Frame: follow up for 4 month
measured with Caliper
follow up for 4 month
Intra operative time
Time Frame: during operation
measured with time calculation
during operation
Post operative pain: VAS
Time Frame: follow up for 2 weeks up to 4 month
measured with visual analogue scale
follow up for 2 weeks up to 4 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
El-Galaa Military Medical Complex

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: mohamed mounir, Phd, faculty of oral and dental medecine cairo university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 20, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 20, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 20, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 19, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 21, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 21, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • omfs 3-3-3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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