Computer Guided Versus Conventional Augmentation Using Bone Ring

NCT ID: NCT03049137

Last Updated: 2017-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-28

Study Completion Date

2017-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bone Resorption

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Double Blind (Subject, Outcomes Assessor)

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Computer Guided Stent Augmentation

Intervention Type PROCEDURE

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.

Platelet-rich fibrin (PRF)

Intervention Type DRUG

implant

Intervention Type DEVICE

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).

Group Type ACTIVE_COMPARATOR

Free Hand Augmentation

Intervention Type PROCEDURE

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.

Platelet-rich fibrin (PRF)

Intervention Type DRUG

implant

Intervention Type DEVICE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Platelet-rich fibrin (PRF)

Intervention Type DRUG

implant

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Computer Guided Surgery Autograft Autograft

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Cairo University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mohamed Ahmed Younis

Dentist at Ministry Of Health

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Cairo University

Giza, Cairo Governorate, Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Mohamed A Younis, Dentist

Role: CONTACT

01156674425 ext. 0227496383

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

mohamed A Younis, Dentist

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 26644216 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CairoBRG-PRF

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.