Ridge SplittingNCT05010785
Ridge Splitting With Simultaneous Implant Placement Using i-PRF
A study testing Immediate implant placement and alveolar ridge splitting with GBR and i-PRF and Immediate implant placement and alveolar ridge splitting with GBR in people with Ridge Splitting and i-PRF, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
Sohn introduced the concept of sticky bone in which i-PRF is mixed with the granules of bone graft, leading to fabrication of growth factors-enriched bone graft matrix using autologous fibrin glue. This minimizes bone loss and accelerates tissue healing during healing period. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Ridge Splitting, i-PRF, Dental Implant
- What is being tested?
- Immediate implant placement and alveolar ridge splitting with GBR and i-PRF and Immediate implant placement and alveolar ridge splitting with GBR
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Aug 2021to 15 Nov 2022
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- good general health at the time of surgery.
- at least 3 months of healing after tooth extraction.
- horizontally compromised alveolar ridges at least 10 mm high and 3 mm wide.
Who cannot join
- a vertical bone defect in the edentulous ridge.
- thick cortex in the labial/buccal with less cancellous bone inside
- obvious undercut on the labial/buccal side.
- uncontrolled periodontal conditions or other oral disorders.
- history of radiotherapy in the head and neck region.
- uncontrolled diabetes mellitus or other systematic disorders.
Show all 10Show fewer
- smokers.
- Pregnancy.
- non-compliant patients.
- allergic reaction to the medications used
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry, Kafrelsheikh University
Kafr ash Shaykh, 33511
About this study
Official title: Ridge Splitting With Simultaneous Implant Placement Using i-PRF With Guided Bone Regeneration: a Randomized Clinical Trial
Sohn introduced the concept of sticky bone in which i-PRF is mixed with the granules of bone graft, leading to fabrication of growth factors-enriched bone graft matrix using autologous fibrin glue. This minimizes bone loss and accelerates tissue healing during healing period. The present study was conducted to evaluate the clinical and radiographic outcomes following the application of the alveolar ridge splitting in combination with the use of guided bone regeneration (GBR) with or without i-PRF (sticky bone), associated with immediate implant placement in patients with horizontally atrophic jaw bones.
- Conditions
- Ridge Splitting, i-PRF, Dental Implant
- Being tested
- Immediate implant placement and alveolar ridge splitting with GBR and i-PRF, Immediate implant placement and alveolar ridge splitting with GBR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate implant placement and alveolar ridge splitting with GBR and i-PRFProcedure or surgery
Implant insertion and GBR for augmentation of the gap between buccal and lingual plate using bone graft mixed with i-PRF
Immediate implant placement and alveolar ridge splitting with GBRProcedure or surgery
Implant insertion and GBR for augmentation of the gap between buccal and lingual plate
| Study group | Role | What they receive |
|---|---|---|
| alveolar ridge splitting with GBR and i-PRF | Experimental | alveolar ridge splitting in combination with the use of GBR with i-PRF (sticky bone) with immediate implant placement Receives: Procedure: Immediate implant placement and alveolar ridge splitting with GBR and i-PRF |
| alveolar ridge splitting with GBR | Active comparator | alveolar ridge splitting in combination with the use of GBR without i-PRF (sticky bone) with immediate implant placement Receives: Procedure: Immediate implant placement and alveolar ridge splitting with GBR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurements of the amount of bone formation in millimeters around immediately placed dental implants
Measurements of the amount of bone formation in millimeters using GBR with or without the combined effect of i-PRF in the ridge splitting following immediate implant placement.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2021
- Study start20 Aug 2021
- Primary completion3 Nov 2022
- Study completion15 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ridge SplittingStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dalia Rasheed Issa, Kafrelsheikh University
- Investigators
- Dalia R Issa, PhD, Principal investigator, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05010785
- Sponsor's protocol ID
- KFSIRB200-73
- Status last verified
- Dec 2023
- First submitted
- 1 Aug 2021
- Last updated
- 22 Dec 2023
- 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 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ridge Splitting With Simultaneous Implant Placement Using i-PRF With Guided Bone Regeneration: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05010785
- Acronym / sponsor ID
- KFSIRB200-73
- Conditions
- Ridge Splitting, i-PRF, Dental Implant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 20 Aug 2021 (actual)
- Primary completion
- 3 Nov 2022 (actual)
- Study completion
- 15 Nov 2022 (actual)
- First posted
- 18 Aug 2021 (actual)
- 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.
Sohn introduced the concept of sticky bone in which i-PRF is mixed with the granules of bone graft, leading to fabrication of growth factors-enriched bone graft matrix using autologous fibrin glue. This minimizes bone loss and accelerates tissue healing during healing period. The present study was conducted to evaluate the clinical and radiographic outcomes following the application of the alveolar ridge splitting in combination with the use of guided bone regeneration (GBR) with or without i-PRF (sticky bone), associated with immediate implant placement in patients with horizontally atrophic jaw bones.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| alveolar ridge splitting with GBR and i-PRF | Experimental | Procedure: Immediate implant placement and alveolar ridge splitting with GBR and i-PRFalveolar ridge splitting in combination with the use of GBR with i-PRF (sticky bone) with immediate implant placement |
| alveolar ridge splitting with GBR | Active comparator | Procedure: Immediate implant placement and alveolar ridge splitting with GBRalveolar ridge splitting in combination with the use of GBR without i-PRF (sticky bone) with immediate implant placement |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- good general health at the time of surgery.
- at least 3 months of healing after tooth extraction.
- horizontally compromised alveolar ridges at least 10 mm high and 3 mm wide.
Key exclusion criteria (10 listed)
- a vertical bone defect in the edentulous ridge.
- thick cortex in the labial/buccal with less cancellous bone inside
- obvious undercut on the labial/buccal side.
- uncontrolled periodontal conditions or other oral disorders.
- history of radiotherapy in the head and neck region.
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 |
|---|---|---|
| Immediate implant placement and alveolar ridge splitting with GBR and i-PRFImplant insertion and GBR for augmentation of the gap between buccal and lingual plate using bone graft mixed with i-PRF | Procedure or surgery | alveolar ridge splitting with GBR and i-PRF |
| Immediate implant placement and alveolar ridge splitting with GBRImplant insertion and GBR for augmentation of the gap between buccal and lingual plate | Procedure or surgery | alveolar ridge splitting with GBR |
Primary outcome
Measurements of the amount of bone formation in millimeters around immediately placed dental implants
Time frame: 9 months
Measurements of the amount of bone formation in millimeters using GBR with or without the combined effect of i-PRF in the ridge splitting following immediate implant placement.
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 22 Dec 2023.
Related trials for Ridge Splitting
Active, not recruiting
Evaluation of Two Mini-implant Diameters in the Infra-zygomatic Crest Region.
Implant Stability
Active, not recruiting
Computer-Guided Ridge Split and Expansion Using an Electromagnetic Mallet
Reconstruction of Horizontal Ridge Defects
Recruiting
Outcomes of Ridge Splitting Versus Sausage Technique
Bone Loss, Alveolar
Not yet recruiting
Clinical and Radiographic Evaluation of Ridge Splitting With Simultaneous Implant Placement Covered With Concentrated Growth Factor Membranes in Narrow Alveolar Ridge
Narrow Alveolar Ridge, CGF Concentrated Growth Factor
Not yet recruiting
Computer Guided Modified Ridge Splitting Versus Free Hand Technique in Horizontal Deficiency in Posterior Mandible
Horizontal Bone Augmentation, Horizontal Ridge Deficiency
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.
Dalia R Issa, PhD principal investigator
Kafrelsheikh University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate implant placement and alveolar ridge splitting with GBR and i-PRF and Immediate implant placement and alveolar ridge splitting with GBR in people with Ridge Splitting and i-PRF, run by Kafrelsheikh 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 3 inclusion and 10 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 22 Dec 2023. 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?
Measurements of the amount of bone formation in millimeters around immediately placed dental implants (time frame: 9 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 22 Dec 2023.