Computer Guided Versus Conventional Augmentation Using Bone Ring

Not Applicable

• Conditions: Bone Resorption
• Interventions: Procedure: Computer Guided Stent Augmentation; Procedure: Free Hand Augmentation; Drug: Platelet-rich fibrin (PRF); Device: implant

• Registration Number: NCT03049137
• Lead Sponsor: Cairo University

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

Detailed Description

To study the effectiveness of computer guided surgical stents in ridge augmentation with implant insertion compared with free hand augmentation

-Population/Intervention/Comparator/Outcome (PICO)-

Population (P): patients with massive bone resorption horizontally and vertically, severe bone loss around teeth, periodontal disease or traumatic extraction in partially edentulous maxillary anterior region requiring implant insertion.

Intervention (I): simultaneous implant placement with ridge augmentation using computer guided surgical templates with PRF.

Comparator (C): Free hand simultaneous implant placement with ridge augmentation.

Outcome (O): Patient esthetic satisfaction - Augmentation and implant insertion accuracy

Study Timeline

• Status Verified: 2017-02
• Study Start: 2017-02
• Study First Submitted: 2017-02-06
• Study First Submitted QC: 2017-02-08
• Last Update Submitted: 2017-02-08
• Study First Posted: 2017-02-09
• Last Update Posted: 2017-02-09
• Primary Completion: 2017-09
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Computer Guided Stent Augmentation	implant	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.
Computer Guided Stent Augmentation	Computer Guided Stent Augmentation	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.
Free Hand Augmentation	Free Hand Augmentation	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).
Computer Guided Stent Augmentation	Platelet-rich fibrin (PRF)	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.
Free Hand Augmentation	Platelet-rich fibrin (PRF)	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).
Free Hand Augmentation	implant	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).

Primary Outcome Measures

Name	Time	Method
Patient Satisfaction regarding esthetic results.	5 month	outcome will be measured using questionnaire

Secondary Outcome Measures

Name	Time	Method
Accuracy of computer guided surgical templates in comparison with 3D virtual planning.	immediately after procedure	Comparing the results on the patient with the design made by the surgical software.

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Giza, Cairo, Egypt