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Status unknownNCT04017117RCTUpdated Jul 20, 2022

Augmentation of Atrophic Mandibule Using Poly Ether Ether Ketone Mesh

An interventional study of under local anasthesia,Ridge Augmention of posterior atrophic mandible by using mix of autogenous bone graft and bone substitutes is used under PEEK mesh in Mandible Small, sponsored by Cairo University. Status unknown at 1 site in Egypt. Open to participants aged 20 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-20.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
14
Allocation
Randomized
Ages
20 Years to 50 Years
Sex
All
01

Study summary

Comparative study between custom-made polyether ether ketone and titanium mesh for augmentation of atrophic posterior mandible.

Read the detailed description

Designing and manufacturing

  1. The CBCT images of the patient will be used to build a digital model using a 3D planning software (Mimics innovation suite). Based on this model, a machine will be used to mill a pressed and pre-sintered body of PEEK to the desired macroscopic shape.
  1. The size of the machined sheet is enlarged in order to compensate for the sintering shrinkage performed at 1450 C.
  1. After manufacturing, the sheet will be cleaned in an ultrasonic bath of 70% alcohol for 15 min, followed by a brief heating to 1200 C.
  1. It will be again cleaned in an ultrasonic bath for 3x15 min using 90% alcohol.
  1. Thereafter the sheet was placed in an autoclave and sterilized using a standard program.
  1. The sheets will have a thickness of approximately 0.5 - 0.7 mm. b. Surgery
  1. The intraoral area is initially cleaned with chlorhexidine 1 mg/ml.
  2. Local anesthesia is administered.
  3. Horizontal crestal incisions are made lingual of the mid-crest within the keratinized tissue. Vertical releasing incisions are placed on the buccal aspect of the surgical site in the usual manner to provide adequate access and to allow for eventual coronal repositioning.
  4. Then, a full-thickness mucoperiosteal flap is reflected to completely expose the atrophic ridge.
  5. The cortex of the mandibular crest is generously perforated to produce bleeding in multiple sites. The pilot holes for the fixation screws were also prepared at this time.
  6. The barrier is inserted over the mandible and compressed into place, the fixation screws are inserted and no adaptation will be needed as the barrier is custom-made for the edentulous ridge.
  7. The ceramic sheets is cleaned with 3% hydrogen peroxide prior to soft tissue closure.
  8. After fixation of the sheets, the buccal flaps should be coronally repositioned.
  9. Split-thickness periosteal releasing incisions are completed to aid in primary tension-free closure. The flap margins are then advanced over the barrier and approximated to evaluate for tension-free closure.
  10. After a mean of 6 months of uneventful healing, the augmented sites are reopened. The ceramic barrier and fixation screws are identified and removed, followed by Dental implant.

Post-operative care:

Avoid traumatization of the surgical site. Patients must abstain from brushing at the surgical area. Instead, a disinfecting mouth rinse should be used (e.g. chlorhexidine 0.2%).

Instruct the patient not to touch or manipulate the surgical area. Ice packs for 10 minutes every 30 minutes for 24 hours. Do not use removable dentures during the expansion phase. Temporary fixed partial dentures must be adjusted to the expected tissue gain.

No consume of tobacco

Post-operative medications will be prescribed as follows:

Amoxicillin/clavulanic acid tablets 10mg/kg every 12 hours for 7 days, diclofenac potassium 50mg every 8 hours for 4 days and then as needed, metronidazole 5 mg/kg every 8 hours for 7 days and chlorhexidine gluconate 0.1% mouthwash 3 times daily for 14 days.

11b. Criteria for discontinuing or modifying intervention: No protocol for discontinuation of the procedure. 11c. Strategies to improve adherence to intervention: Face to face adherence reminder session will take place to stress on the post-operative instructions at the following time intervals.

Patients were recalled every other day to monitor soft tissue healing for the first week, one visit weekly for the first month then monthly for 6 months.

02

Conditions studied

  • Mandible Small

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03

In context

Micrognathism

26 studies on the registry are indexed under Micrognathism; 7 are open to participants now.

This study's planned enrollment of 14 is below the median of 24 across 22 interventional studies indexed under Micrognathism.

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Lead sponsor

Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patients with atrophic posterior mandible
  2. Both sexes
  3. No intraoral soft and hard tissue pathology
  4. No systemic condition that contraindicate implant placement

Exclusion criteria

Exclusion Criteria:

  1. Untreated gingivitis, periodontitis
  2. Insufficient oral hygiene
  3. Previous radiation therapy the head and neck neoplasia, or bone augmentation to implant site.
  4. Systemic disorders
  5. Heavy smoking more than 20 cigarettes per day
  6. Bone pathology
  7. Psychiatric problems
  8. Emotional instability
  9. Unrealistic aesthetic demands
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
14 participants (estimated)

Study arms

  • Experimental
    Custom Made Poly Ether Ether Ketone Mesh

    Applying Poly Ether Ether Ketone mesh with mix of autogenous bone graft and bone substitute in posterior atrophic mandible for augmentation

    Procedure: under local anasthesia,Ridge Augmention of posterior atrophic mandible by using mix of autogenous bone graft and bone substitutes is used under PEEK mesh

  • Active comparator
    Conventional Titanium mesh

    Applying Titanium mesh with mix of autogenous bone graft and bone substitute in posterior atrophic mandible for augmentation

    Procedure: under local anasthesia,Ridge Augmention of posterior atrophic mandible by using mix of autogenous bone graft and bone substitutes is used under PEEK mesh

Interventions

  • Procedureunder local anasthesia,Ridge Augmention of posterior atrophic mandible by using mix of autogenous bone graft and bone substitutes is used under PEEK mesh

    comparing between PEEK mesh and Titanium mesh for augmentation of posterior atrophic mandible using mix of autogenous bone graft and bone substitute.

06

What researchers measure

Primary outcomes

  1. Vertical amount of bone increased (length in millimeters). horizontal amount f bone increased after augmentation (width in millimeters).

    Length (Vertical Augmentation) Width (horizontal augmentation) gained after augmentation of atrophic mandible in millimeters using cone beam computed tomography (measuring tool) measurment tools : with the aid of cone beam computed tomography

    Time frame: 6 months

Secondary outcomes

  1. Rate of Soft Tissue Dehiscence

    which mesh will cause soft tissue dehiscence more.

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • Misch CM. Bone augmentation of the atrophic posterior mandible for dental implants using rhBMP-2 and titanium mesh: clinical technique and early results. Int J Periodontics Restorative Dent. 2011 Nov-Dec;31(6):581-9. PubMed 22140660 ↗
  • Her S, Kang T, Fien MJ. Titanium mesh as an alternative to a membrane for ridge augmentation. J Oral Maxillofac Surg. 2012 Apr;70(4):803-10. doi: 10.1016/j.joms.2011.11.017. Epub 2012 Jan 28. PubMed 22285340 ↗
  • Pieri F, Corinaldesi G, Fini M, Aldini NN, Giardino R, Marchetti C. Alveolar ridge augmentation with titanium mesh and a combination of autogenous bone and anorganic bovine bone: a 2-year prospective study. J Periodontol. 2008 Nov;79(11):2093-103. doi: 10.1902/jop.2008.080061. PubMed 18980518 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 20, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04017117
Lead sponsor
Cairo University
Responsible party
Adham Zakaria (Master Degree Candidate., Cairo University) — Principal investigator
First posted
Jul 12, 2019
Start date
Jun 25, 2019
Primary completion
Nov 25, 2022 (estimated)
Completion
Dec 1, 2022 (estimated)
Last update
Jul 20, 2022

Study contacts

Adham Y Zakaria, Master
Contact
amira_5queens@hotmail.com
00201226000564
Adham Y Zakaria, Master
Contact
00201226000741
Mohamed F Shehab, PHD
study director · Professor of Oral and Maxillofacial Surgery - Cairo University.
Khaled A Salaheddin, PHD
study director · Lecturer of Oral and Maxillofacial Surgery - Cairo University.

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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