Bone ResorptionNCT03049137
Computer Guided Versus Conventional Augmentation Using Bone Ring
A study testing Computer Guided Stent Augmentation, Free Hand Augmentation and Platelet-rich fibrin (PRF) in people with Bone Resorption, run by Cairo University at 1 site in Egypt.
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 Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Resorption
- What is being tested?
- Computer Guided Stent Augmentation, Free Hand Augmentation and Platelet-rich fibrin (PRF)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- Feb 2017to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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
- Conditions
- Bone Resorption
- Being tested
- Computer Guided Stent Augmentation, Free Hand Augmentation, Platelet-rich fibrin (PRF), implant
- Medical subject headings
- Bone Resorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer Guided Stent AugmentationProcedure or surgery
Also called Computer Guided Surgery, Autograft
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 AugmentationProcedure or surgery
Also called Autograft
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)Drug
implantDevice
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Computer Guided Stent Augmentation; Drug: 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). Receives: Procedure: Free Hand Augmentation; Drug: Platelet-rich fibrin (PRF); Device: implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Satisfaction regarding esthetic results.
outcome will be measured using questionnaire
Measured: 5 month
Secondary outcomes (1)
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.
Measured: immediately after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2017 (estimated)
- Study startFeb 2017 (estimated)
- Primary completionSep 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bone ResorptionStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ahmed Younis, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03049137
- Sponsor's protocol ID
- CairoBRG-PRF
- Status last verified
- Feb 2017
- First submitted
- 6 Feb 2017
- Last updated
- 9 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Evaluation of The Comparative Effectiveness of Computer Guided Surgical stents in Anterior Ridge Defects with Bone Ring Graft and PRF
Publications
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.
PubMed 26644216
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03049137
- Acronym / sponsor ID
- CairoBRG-PRF
- Conditions
- Bone Resorption
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Feb 2017 (estimated)
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 9 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Computer Guided Stent Augmentation | Experimental | Procedure: Computer Guided Stent Augmentation, Drug: Platelet-rich fibrin (PRF), Device: implantPatients 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 | Active comparator | Procedure: Free Hand Augmentation, Drug: Platelet-rich fibrin (PRF), Device: implantPatients 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). |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computer Guided Stent AugmentationAlso: Computer Guided Surgery, AutograftDefective 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. | Procedure or surgery | Computer Guided Stent Augmentation |
| Free Hand AugmentationAlso: AutograftDefective 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. | Procedure or surgery | Free Hand Augmentation |
| Platelet-rich fibrin (PRF) | Drug | Computer Guided Stent Augmentation, Free Hand Augmentation |
| implant | Device | Computer Guided Stent Augmentation, Free Hand Augmentation |
Primary outcome
Patient Satisfaction regarding esthetic results.
Time frame: 5 month
outcome will be measured using questionnaire
1 secondary outcome
Accuracy of computer guided surgical templates in comparison with 3D virtual planning.
Time frame: immediately after procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2017.
- Background: PubMed 26644216Omara 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.
- Individual participant dataSharing planned: No. Evaluation of The Comparative Effectiveness of Computer Guided Surgical stents in Anterior Ridge Defects with Bone Ring Graft and PRF
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computer Guided Stent Augmentation, Free Hand Augmentation and Platelet-rich fibrin (PRF) in people with Bone Resorption, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed A Younis, Dentist (01156674425 ext. 0227496383, younismatador@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Satisfaction regarding esthetic results. (time frame: 5 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03049137, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2017.