Ridge DeficiencyNCT03037125
The Evaluation Of Bone Width Gain Following Split Crest Technique With Or Without Platelet Rich Fibrin( PRF)
A study testing Split Crest with PRF and Split Crest without PRF in people with Ridge Deficiency, run by Cairo University at 1 site in Egypt.
Trial summary
Split crest technique is a technique for horizontal bone augmentation used in case of narrow alveolar ridges as an alternative to the more aggressive techniques such as onlay bone grafting, guided bone regeneration (GBR) and distraction osteogenesis The study goal is to evaluate whether if there will be any benefit of… Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Ridge Deficiency
- What is being tested?
- Split Crest with PRF and Split Crest without PRF
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2017to 1 Jun 2019
- 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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with at least one missing tooth in the maxillary region
- All the selected patients have a bucco-palatal width of the edentulous alveolar ridge from 3.5-5.5mm.
- All the selected patients have at least 12 mm residual bone height at the edentulous area
- The recipient site of the implant should be free from any pathological conditions.
- No diagnosed bone disease or medication known to affect bone metabolism.
- Patients who are cooperative, motivated, and hygiene conscious.
Who cannot join
- Patients unable to undergo minor oral surgical procedures.
- Patients with a history of drug abuse or catabolic drugs.
- Patients with a history of psychiatric disorder.
- Patients with unrealistic expectations about the esthetic outcome of implant therapy.
- Patients with insufficient vertical inter-arch space, upon centric occlusion, to accommodate the available restorative components.
- Patients in the growth stage with partially erupted teeth.
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- Patients who have any systemic condition that may contraindicate implant therapy.
- Patients who have any habits that might jeopardize the osseointegration process, such as smoking and alcoholism.
- Patients with parafunctional habits that produce overload on the implant, such as bruxism and clenching.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of oral and dental medicine, Cairo university
Cairo, 4240310
About this study
Official title: The Evaluation Of Bone Width Gain Following Split Crest Technique With Or Without PRF In Conjunction With Simultaneous Implant Placement In Narrow Alveolar Ridges: A Randomized Controlled Clinical Trial
Split crest technique is a technique for horizontal bone augmentation used in case of narrow alveolar ridges as an alternative to the more aggressive techniques such as onlay bone grafting, guided bone regeneration (GBR) and distraction osteogenesis
The study goal is to evaluate whether if there will be any benefit of using platelet rich fibrin (PRF) with the split crest technique regarding bone width gain and healing response in comparison with split crest technique alone, where PRF is considered an autologous, growth factor containing material which is easy to collect and is of low cost.
- Conditions
- Ridge Deficiency
- Being tested
- Split Crest with PRF, Split Crest without PRF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Split Crest with PRFProcedure or surgery
Narrow ridges are split to increase the ridge width and immediate implants are placed with PRF closing the gap
Split Crest without PRFProcedure or surgery
Narrow ridges are split to increase the ridge width and immediate implants are placed without grafting
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | Active comparator | Split crest without PRF Receives: Procedure: Split Crest without PRF |
| Intervention Arm | Experimental | Split crest with PRF Receives: Procedure: Split Crest with PRF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone width gain
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2017 (estimated)
- Study start1 Mar 2017
- Primary completion15 Mar 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ridge DeficiencyStudies 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
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Youssef Emad Zaghloul Meshreky, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03037125
- Sponsor's protocol ID
- PERIO 3:7:3
- Status last verified
- May 2024
- First submitted
- 19 Jan 2017
- Last updated
- 28 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation Of Bone Width Gain Following Split Crest Technique With Or Without PRF In Conjunction With Simultaneous Implant Placement In Narrow Alveolar Ridges: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03037125
- Acronym / sponsor ID
- PERIO 3:7:3
- Conditions
- Ridge Deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 15 Mar 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 31 Jan 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.
Split crest technique is a technique for horizontal bone augmentation used in case of narrow alveolar ridges as an alternative to the more aggressive techniques such as onlay bone grafting, guided bone regeneration (GBR) and distraction osteogenesis
The study goal is to evaluate whether if there will be any benefit of using platelet rich fibrin (PRF) with the split crest technique regarding bone width gain and healing response in comparison with split crest technique alone, where PRF is considered an autologous, growth factor containing material which is easy to collect and is of low cost.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm | Active comparator | Procedure: Split Crest without PRFSplit crest without PRF |
| Intervention Arm | Experimental | Procedure: Split Crest with PRFSplit crest with PRF |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with at least one missing tooth in the maxillary region
- All the selected patients have a bucco-palatal width of the edentulous alveolar ridge from 3.5-5.5mm.
- All the selected patients have at least 12 mm residual bone height at the edentulous area
- The recipient site of the implant should be free from any pathological conditions.
- No diagnosed bone disease or medication known to affect bone metabolism.
Key exclusion criteria (9 listed)
- Patients unable to undergo minor oral surgical procedures.
- Patients with a history of drug abuse or catabolic drugs.
- Patients with a history of psychiatric disorder.
- Patients with unrealistic expectations about the esthetic outcome of implant therapy.
- Patients with insufficient vertical inter-arch space, upon centric occlusion, to accommodate the available restorative components.
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 |
|---|---|---|
| Split Crest with PRFNarrow ridges are split to increase the ridge width and immediate implants are placed with PRF closing the gap | Procedure or surgery | Intervention Arm |
| Split Crest without PRFNarrow ridges are split to increase the ridge width and immediate implants are placed without grafting | Procedure or surgery | Control Arm |
Primary outcome
Bone width gain
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Split Crest with PRF and Split Crest without PRF in people with Ridge Deficiency, 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 6 inclusion and 9 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: finished, as of the sponsor's last update on 28 May 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone width gain (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 May 2024.