NCT03049137

Brief Summary

Using bone ring grafts with simultaneous implant placement after three-dimensional augmentation of severely defective bone ridges using computer-guided surgical templates. The study compares accuracy effectiveness by mimics software

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2017

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

February 6, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 9, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

February 9, 2017

Status Verified

February 1, 2017

Enrollment Period

7 months

First QC Date

February 6, 2017

Last Update Submit

February 8, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Patient Satisfaction regarding esthetic results.

    outcome will be measured using questionnaire

    5 month

Secondary Outcomes (1)

  • Accuracy of computer guided surgical templates in comparison with 3D virtual planning.

    immediately after procedure

Study Arms (2)

Computer Guided Stent Augmentation

EXPERIMENTAL

Patients with defective maxillary anterior alveolar ridges requiring implant insertion will have simultaneous implant placement with ridge augmentation using autogenous bone ring graft covering them with Platelet-rich fibrin (PRF) using computer guided stent.

Procedure: Computer Guided Stent AugmentationDrug: Platelet-rich fibrin (PRF)Device: implant

Free Hand Augmentation

ACTIVE COMPARATOR

Patients with defective maxillary anterior alveolar ridges requiring implant insertion will have simultaneous implant placement with ridge augmentation using Free hand simultaneous implant placement with ridge augmentation and covering them with Platelet-rich fibrin (PRF).

Procedure: Free Hand AugmentationDrug: Platelet-rich fibrin (PRF)Device: implant

Interventions

Defective alveolar ridge is to be replaced by simultaneous implant placement with ring graft augmentation (Trephine Drill to obtain the ring graft autogenous bone) using computer guided stent and covered with Platelet-rich fibrin (PRF), by using venous blood from the patient, a centrifuge will be used to obtain the top layer after centrifuging blood at 3000 Revolution Per Minute (RPM) for 10 minutes.

Also known as: Computer Guided Surgery, Autograft
Computer Guided Stent Augmentation

Defective alveolar ridge is to be replaced by Free Hand simultaneous implant placement with ring graft augmentation (Trephine Drill to obtain the ring graft autogenous bone) and covered with Platelet-rich fibrin (PRF), by using venous blood from the patient, a centrifuge will be used to obtain the top layer after centrifuging blood at 3000 RPM for 10 minutes.

Also known as: Autograft
Free Hand Augmentation
Computer Guided Stent AugmentationFree Hand Augmentation
implantDEVICE
Computer Guided Stent AugmentationFree Hand Augmentation

Eligibility Criteria

Age21 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with insufficient alveolar ridge or severe alveolar bone resorption horizontally and vertically in partially edentulous maxillary anterior region.
  • Medically free patients in order to be a confounding factor on the final results.
  • Highly motivated patients.
  • Good oral hygiene.
  • Patients physically able to tolerate surgical and restorative procedures.

You may not qualify if:

  • Young patients (incomplete bone growth).
  • Patients with any systemic disease that could affect bone healing.
  • Patients allergic to local anaesthetic agent.
  • Pregnant or lactating females.
  • Presence of any pathosis in the area.
  • history of oral radiotherapy.
  • history of prolonged steroid use.
  • Psychological disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Giza, Cairo Governorate, Egypt

Location

Related Publications (1)

  • Omara M, Abdelwahed N, Ahmed M, Hindy M. Simultaneous implant placement with ridge augmentation using an autogenous bone ring transplant. Int J Oral Maxillofac Surg. 2016 Apr;45(4):535-44. doi: 10.1016/j.ijom.2015.11.001. Epub 2015 Nov 28.

    PMID: 26644216BACKGROUND

MeSH Terms

Conditions

Bone Resorption

Interventions

Surgery, Computer-AssistedTransplantation, AutologousMutagenesis, Insertional

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, OperativeTransplantationProtein EngineeringGenetic EngineeringGenetic TechniquesInvestigative TechniquesMutationGenetic VariationGenetic PhenomenaMutagenesis

Central Study Contacts

Mohamed A Younis, Dentist

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Double Blind (Subject, Outcomes Assessor)
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dentist at Ministry Of Health

Study Record Dates

First Submitted

February 6, 2017

First Posted

February 9, 2017

Study Start

February 1, 2017

Primary Completion

September 1, 2017

Study Completion

December 1, 2017

Last Updated

February 9, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Evaluation of The Comparative Effectiveness of Computer Guided Surgical stents in Anterior Ridge Defects with Bone Ring Graft and PRF

Locations