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Mandible SmallRCTNCT04017117

Augmentation of Atrophic Mandibule Using Poly Ether Ether Ketone Mesh

A study testing 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 people with Mandible Small, run by Cairo University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages 20 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Mandible Small
What is being tested?
under local anasthesia,Ridge Augmention of posterior atrophic mandible by using mix of autogenous bone graft and bone substitutes is used under PEEK mesh
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteEgypt
Study dates
25 Jun 2019to 1 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Patients with atrophic posterior mandible
  • Both sexes
  • No intraoral soft and hard tissue pathology
  • No systemic condition that contraindicate implant placement

Who cannot join

  • Untreated gingivitis, periodontitis
  • Insufficient oral hygiene
  • Previous radiation therapy the head and neck neoplasia, or bone augmentation to implant site.
  • Systemic disorders
  • Heavy smoking more than 20 cigarettes per day
  • Bone pathology
Show all 9Show fewer
  • Psychiatric problems
  • Emotional instability
  • Unrealistic aesthetic demands

Trial locations and contacts

1 site in 1 country.

Adham Y Zakaria, Master contact

00201226000564

amira_5queens@hotmail.com

Adham Y Zakaria, Master contact

00201226000741

Egypt1 site, 1 recruiting
  • Faculty Of Dental and Oral Medicine-Cairo University

    Cairo

    Adham Y Zakaria, Master, 00201226000564, amira_5queens@hotmail.com

    Adham Y Zakaria, Master, 00201226000741, amira_5queens@hotmail.com

    Recruiting

Other trials in Egypt

About this study

Official title: Comparative Study Between Custom-made Polyether Ether Ketone and Titanium Mesh for Augmentation of Atrophic Posterior Mandible. Randomized Clinical Trial

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.
  2. The size of the machined sheet is enlarged in order to compensate for the sintering shrinkage performed at 1450 C.
  3. 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.
  4. It will be again cleaned in an ultrasonic bath for 3x15 min using 90% alcohol.
  5. Thereafter the sheet was placed in an autoclave and sterilized using a standard program.
  6. The sheets will have a thickness of approximately 0.5 - 0.7 mm. b. Surgery
  7. The intraoral area is initially cleaned with chlorhexidine 1 mg/ml.
  8. Local anesthesia is administered.
  9. 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.
  10. Then, a full-thickness mucoperiosteal flap is reflected to completely expose the atrophic ridge.
  11. 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.
  12. 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.
  13. The ceramic sheets is cleaned with 3% hydrogen peroxide prior to soft tissue closure.
  14. After fixation of the sheets, the buccal flaps should be coronally repositioned.
  15. 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.
  16. 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.

Conditions
Mandible Small
Being tested
under local anasthesia,Ridge Augmention of posterior atrophic mandible by using mix of autogenous bone graft and bone substitutes is used under PEEK mesh
Medical subject headings
Micrognathism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

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

Study groups in NCT04017117
Study groupRoleWhat they receive
Custom Made Poly Ether Ether Ketone MeshExperimentalApplying Poly Ether Ether Ketone mesh with mix of autogenous bone graft and bone substitute in posterior atrophic mandible for augmentation
Receives: 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
Conventional Titanium meshActive comparatorApplying Titanium mesh with mix of autogenous bone graft and bone substitute in posterior atrophic mandible for augmentation
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 6 months

Secondary outcomes (1)
  1. Rate of Soft Tissue Dehiscence

    which mesh will cause soft tissue dehiscence more.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2019
  2. Study start25 Jun 2019
  3. Primary completion25 Nov 2022 (estimated)
  4. Study completion1 Dec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
A Randomized Clinical Trial. A trial will be carried out in hospital of Oral and Maxillofacial surgery department,Faculty of Oral and Dental Medicine Cairo University Equal randomization parallel group study positive controlled
Masking
None (open label)
Enrolment
14 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04017117
Sponsor's protocol ID
CEBD-CU-2019-06-19
Acronym
RCT
Status last verified
Jul 2022
First submitted
25 Jun 2019
Last updated
20 Jul 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A study testing 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 people with Mandible Small, run by Cairo University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Adham Y Zakaria, Master (00201226000564, amira_5queens@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Vertical amount of bone increased (length in millimeters). horizontal amount f bone increased after augmentation (width in millimeters). (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04017117, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2022.

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