Augmentation of Atrophic Mandibule Using Poly Ether Ether Ketone Mesh

NCT04017117 | Unknown

• 1 other identifier: CEBD-CU-2019-06-19
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Mandible Small

Outcome Measures

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

  6 months

Secondary Outcomes (1)

• Rate of Soft Tissue Dehiscence

  6 months

Study Arms (2)

Custom Made Poly Ether Ether Ketone Mesh

EXPERIMENTAL

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

Conventional Titanium mesh

ACTIVE COMPARATOR

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

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

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

Conventional Titanium mesh; Custom Made Poly Ether Ether Ketone Mesh

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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
• Psychiatric problems
• Emotional instability
• Unrealistic aesthetic demands

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty Of Dental and Oral Medicine-Cairo University

Cairo, Egypt

RECRUITING

Related Publications (3)

• 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.

  PMID: 22140660 BACKGROUND

• 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.

  PMID: 22285340 BACKGROUND

• 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.

  PMID: 18980518 RESULT

Related Links

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MeSH Terms

Conditions

Micrognathism

Condition Hierarchy (Ancestors)

Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Mohamed F Shehab, PHD

  Professor of Oral and Maxillofacial Surgery - Cairo University.

  STUDY DIRECTOR

• Khaled A Salaheddin, PHD

  Lecturer of Oral and Maxillofacial Surgery - Cairo University.

  STUDY DIRECTOR

Central Study Contacts

Adham Y Zakaria, Master

CONTACT

00201226000564; amira_5queens@hotmail.com

Adham Y Zakaria, Master

CONTACT

00201226000741

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master Degree Candidate.

Model Details: 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

Study Record Dates

• First Submitted: June 25, 2019
• First Posted: July 12, 2019
• Study Start: June 25, 2019
• Primary Completion: November 25, 2022
• Study Completion: December 1, 2022
• Last Updated: July 20, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)