Ridge Augmentation Using Patient Specific PEEK Sheets vs. Autogenous Bone Shell Technique.

NCT03607006 | Completed DMC

• 1 other identifier: CEBD-CU-2018-07-16
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

Comparative study to assess the ability of the patient specific PEEK sheets in ridge augmentation with using mixed Autogenous/Xenogenic bone graft vs the Bone Shell Technique regarding the time, accuracy and donor site morbidity .

Conditions

Ridge Deficiency

Keywords

Anterior maxillary region; Patient specific; Autogenous bone shell; PEEK; Ridge augmentation

Outcome Measures

Primary Outcomes (1)

• Patient satisfaction

  Questionnaire will be used to evaluate the satisfaction , measuring unit Binary (YES/NO)

  8 months

Secondary Outcomes (4)

• Bone gain

  4-6 months post-operative

• Bone quality

  4-6 months post-operative

• Soft tissue reaction

  4-6 months postoperative

• Intraoperative time

  Intraoperative

Study Arms (2)

Patient specific PEEK sheets

EXPERIMENTAL

Patient specific PEEK sheets will be fixed with titanium screws and act as containment system for the mixed autogenous/xenogenic bone graft that will fill the gap between the sheets and the ridge .

Procedure: Patient specific PEEK sheets

Autogenous bone shell technique

ACTIVE COMPARATOR

Bone shells will be fixed with titanium screws to the ridge and mixed autogenous/xenogenic bone graft will fill the gap between the shells and the ridge .

Procedure: Autogenous bone shell

Interventions

Patient specific PEEK sheets PROCEDURE

Computer aided sheet design

Patient specific PEEK sheets

Autogenous bone shell PROCEDURE

autogenous retromolar/chin bone graft

Autogenous bone shell technique

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients with deficient alveolar bone in the anterior maxilla.
• Patient seeking fixed prosthesis at the anterior maxillary region.
• Highly motivated patients.
• Good oral hygiene.
• Patients willing for the surgical procedure and follow-up, with an informed consent.
• Bounded anterior maxilla cases.

You may not qualify if:

• Medically compromised patients.
• Uncooperative patients.
• Poor oral hygiene.
• Periodontal diseases.
• No history of any grafting procedure at the designated edentulous ridge.Criteria
• Patients with any diseases that compromise bone or soft tissue healing.
• Patients with no local pathosis that interfere with the bone healing.

Sponsors & Collaborators

• Ola Alaa El-Din Abd El-Monem Mohamed: lead
• Cairo University: collaborator

Study Sites (1)

Faculty of Oral and Dental Medicine - Cairo University

Giza, 12613, Egypt

Location

Related Publications (1)

• Mounir M, Morsy OAE, Amer H, Mounir S, Gibaly A. Assessment of bone quality using buccal and palatal autogenous cortical shells harvested from two different mandibular donor sites for maxillary alveolar ridge augmentation: a histomorphometric randomized clinical trial. Oral Maxillofac Surg. 2021 Jun;25(2):263-269. doi: 10.1007/s10006-020-00924-w. Epub 2020 Nov 24.

  PMID: 33231752 DERIVED

Study Officials

• Ahmed A Brakart, PhD

  Cairo University

  STUDY DIRECTOR

• Mohamed M Shaker, PhD

  Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: None because the two interventions requires different preoperative preparations , both the participants and the investigator can't be blinded .
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principle Investigator

Model Details: * A randomized clinical trial. * Parallel group study. * A trial will be carried out in hospital of Oral and Maxillofacial surgery department - Faculty of Oral and Dental Medicine - Cairo University . * Equal randomization : participants with equal probabilities for intervention. * Positive controlled : Both groups receiving treatment.

Study Record Dates

• First Submitted: July 23, 2018
• First Posted: July 31, 2018
• Study Start: July 10, 2018
• Primary Completion: March 31, 2019
• Study Completion: March 31, 2019
• Last Updated: April 9, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)