Computer Guided Versus Conventional Augmentation Using Bone Ring

Bone Resorption Clinical Trial

Official title:

Evaluation of Computer-Guided Versus Conventional Simultaneous Implant Placement With Ridge Augmentation Using an Autogenous Bone Ring Graft With PRF on Patient's Esthetic Satisfaction

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03049137
• Other study ID #: CairoBRG-PRF
• Status: Not yet recruiting
• Phase: N/A
• First received: February 6, 2017
• Last updated: February 8, 2017
• Start date: February 2017
• Est. completion date: December 2017

Study information

• Verified date: February 2017
• Source: Cairo University
• Contact: Mohamed A Younis, Dentist
• Phone: 01156674425
• Email: younismatador[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: December 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bone Resorption

Intervention

Procedure:
• Computer Guided Stent Augmentation
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.
• Free Hand 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.

Drug:
• Platelet-rich fibrin (PRF)

Device:
• implant

Locations

Country	Name	City	State
Egypt	Cairo University	Giza	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Satisfaction regarding esthetic results.	outcome will be measured using questionnaire	5 month
Secondary	Accuracy of computer guided surgical templates in comparison with 3D virtual planning.	Comparing the results on the patient with the design made by the surgical software.	immediately after procedure