Bone Loss, AlveolarNCT03855852
Evaluation of Vertical Bone Gain After Ridge Augmentation With APRF & Xenograft Vs Collagen Membrane & Xenograft. RCT
A study testing Xenograft and Collagen membrane and Xenograft and APRF in people with Bone Loss, Alveolar, run by Cairo University at 1 site in Egypt.
Trial summary
Comparative study for evaluation of vertical bone gain after one stage ridge augmentation with advanced platelet rich fibrin (A-PRF) and xenograft versus guided bone regeneration using collagen membrane and xenograft. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Bone Loss, Alveolar
- What is being tested?
- Xenograft and Collagen membrane and Xenograft and APRF
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2019to 1 Jun 2020
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years old.
- Systemically healthy.
- Has good dental health.
- Missing a single tooth in the maxillary anterior and premolar region
- Crestal residual ridge width of 4-5mm.
- Residual ridge with an adequate band of keratinized tissue (2 mm).
- Residual ridge with sufficient vertical bone height to safely place a >10 mm long dental implant.
Who cannot join
- Severe parafunctional habits, for example, bruxing and clenching.
- Conditions that complicate wound healing, for example, uncontrolled diabetes (defined as HBA1c level >7%) or smoking.
- Conditions that might lead to a possibly lowered regenerative capacity of the bone, for example, osteoporosis and Paget's disease.
- Pregnant or expecting to be pregnant.
- History of drug and alcohol abuse or certain medications like bisphosphonates or steroids currently or within the past three months.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry , Cairo University
Giza, 12613
Abdallah W Shabir, B.D.S, 01281855966, abdallah.w.shabir@outlook.com
Manal M Hosny, Professor, 01118459362, manhosny@gmail.com
About this study
Official title: Evaluation Of Vertical Bone Gain Following One Stage Ridge Augmentation With Advanced Platelet Rich Fibrin (A-PRF) And Xenograft Compared to Guided Bone Regeneration Using Collagen Membrane and Xenograft.
Comparative study for evaluation of vertical bone gain after one stage ridge augmentation with advanced platelet rich fibrin (A-PRF) and xenograft versus guided bone regeneration using collagen membrane and xenograft.
Read the detailed description
Summry description
- Dental implants represent a reliable mean for replacing missing teeth and restoring dental function.
- With increased use of dental implants in replacement of missing teeth in partially edentulous patients the need for implants that satisfy both esthetics and function .
- Thus, the concept of restoration-driven implant placement has been introduced to provide a good match between the position of implant and the future position of the implant supported-restoration to provide a good clinical outcome.
- The concept of prosthetic-driven implant dimensional changes are expected in the hard and soft tissues.
- About 50% of alveolar bone loss occurs in the buccolingual direction in the first 12 months after tooth extraction.
- The alveolar process can be too narrow to facilitate a complete bony surrounding of the placed dental implant.
- Which may lead to a peri-implant bony dehiscence when placing an implant.
- One stage ridge augmentation procedure has been advocated in management of buccal dehiscence and fenestration defects that may develop with implant placement according to prosthetic-driven implant placement concept.
- Guided bone regeneration techniques (GBR) are commonly used in management of these defects.
- However, controversy still exists concerning the complications that may arise such as membrane exposure and its effects on bone regeneration and the possibility of using bone grafts alone to overcome these problems.
- This research promotes the evaluation of A-PRF in combination with xenograft in one stage ridge augmentation.
- The addition of A-PRF to bone grafts has been reported to enhance the process of bone regeneration through different mechanisms.
- Ridge augmentation according to the principle of GBR using collagen membrane and bone graft has been proven to be predictable in producing significant bone gain promoting implant placement.
- The aim of the study is to clinically evaluate vertical bone gain in buccal peri-implant dehiscence and fenestration defects following application of advanced PRF plus xenograft compared to guided bone regeneration using collagen membrane and xenograft.
Surgical procedure:
- Control group: (Implant placement with xenograft and collagen membrane) After Para crestal incision and raising the mucoperiosteal flap at the top of the alveolar process, the exact position of the dental implant will be defined as determined by preoperative measurements, dental setup, and surgical guide. Bone level implants will be placed 3 mm apical to the expected cervical border of the crown.
The titanium surface of the dental implant will be covered with bone graft (xenograft), and coverage with a resorbable collagen membrane.
-Test group: (implant placement with xenograft and A-PRF) The alveolar bone exposure and implant osteotomy will be prepared and inserted in same manner as in the control group. The titanium surface of the dental implant will be covered with A-PRF and xenograft.
- Conditions
- Bone Loss, Alveolar
- Being tested
- Xenograft and Collagen membrane, Xenograft and APRF
- Keywords
- vertical bone defect, Ridge augmentation, One stage, Xenograft, Collagen membrane, Advanced platelet rich fibrin, Guided bone regeneration, Surgical template, Implant, horizontal bone defect
- Medical subject headings
- Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xenograft and Collagen membraneProcedure or surgery
Placing the implant with collagen membrane and xenograft at esthetic zone of maxillary ridge with 2-4 mm thread exposure .
Xenograft and APRFProcedure or surgery
Placing the implant with APRF and xenograft at esthetic zone of maxillary ridge with 2-4 mm thread exposure .
| Study group | Role | What they receive |
|---|---|---|
| Xenograft and Collagen membrane | Active comparator | Placing the implant with collagen membrane and xenograft at esthetic zone of maxillary ridge when 2-4 mm of implant threads exposure . Receives: Procedure: Xenograft and Collagen membrane |
| Xenograft and A-PRF | Experimental | Placing the implant with xenograft and A-PRF at esthetic zone of maxillary ridge when 2-4 mm of implant threads exposure . Receives: Procedure: Xenograft and APRF |
What is being measured
The primary outcome is the main question the study is designed to answer.
vertical buccal bone gain
It will be measured using UNC Periodontal probe
Measured: 6 months
Secondary outcomes (3)
horizontal bone gain
It will be measured using UNC Periodontal probe
Measured: 6 months
Ridge width
It will be measured using bone caliper
Measured: 6 months
Post-surgical patient satisfaction
It will be measured using Questionnaire
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 posted27 Feb 2019
- Study start1 Feb 2019
- Primary completion1 Mar 2020 (estimated)
- Study completion1 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Loss, AlveolarStudies 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
- Model description
- Parallel Assignment * A Randomized clinical trial * Parallel study group * A trial will be carried out in outpatient clinic of Periodontology Department ,Faculty of Dentistry , Cairo University . * Equal randomization with equal probabilities for intervention. * Positive controlled : Both groups will receive treatment
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdallah waleed sobhi Shbair, Cairo University
- Investigators
- Abdallah M Shbair, B.D.S, Principal investigator, Dr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03855852
- Sponsor's protocol ID
- CEBD-CU-2019-02-15
- Status last verified
- May 2019
- First submitted
- 25 Feb 2019
- Last updated
- 16 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of Vertical Bone Gain Following One Stage Ridge Augmentation With Advanced Platelet Rich Fibrin (A-PRF) And Xenograft Compared to Guided Bone Regeneration Using Collagen Membrane and Xenograft.
- ClinicalTrials.gov ID
- NCT03855852
- Acronym / sponsor ID
- CEBD-CU-2019-02-15
- Conditions
- Bone Loss, Alveolar
- Keywords
- vertical bone defect, Ridge augmentation, One stage, Xenograft, Collagen membrane, Advanced platelet rich fibrin, Guided bone regeneration, Surgical template
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Mar 2020 (estimated)
- Study completion
- 1 Jun 2020 (estimated)
- First posted
- 27 Feb 2019 (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.
Comparative study for evaluation of vertical bone gain after one stage ridge augmentation with advanced platelet rich fibrin (A-PRF) and xenograft versus guided bone regeneration using collagen membrane and xenograft.
Detailed description
Summry description
- Dental implants represent a reliable mean for replacing missing teeth and restoring dental function.
- With increased use of dental implants in replacement of missing teeth in partially edentulous patients the need for implants that satisfy both esthetics and function .
- Thus, the concept of restoration-driven implant placement has been introduced to provide a good match between the position of implant and the future position of the implant supported-restoration to provide a good clinical outcome.
- The concept of prosthetic-driven implant dimensional changes are expected in the hard and soft tissues.
- About 50% of alveolar bone loss occurs in the buccolingual direction in the first 12 months after tooth extraction.
- The alveolar process can be too narrow to facilitate a complete bony surrounding of the placed dental implant.
- Which may lead to a peri-implant bony dehiscence when placing an implant.
- One stage ridge augmentation procedure has been advocated in management of buccal dehiscence and fenestration defects that may develop with implant placement according to prosthetic-driven implant placement concept.
- Guided bone regeneration techniques (GBR) are commonly used in management of these defects.
- However, controversy still exists concerning the complications that may arise such as membrane exposure and its effects on bone regeneration and the possibility of using bone grafts alone to overcome these problems.
- This research promotes the evaluation of A-PRF in combination with xenograft in one stage ridge augmentation.
- The addition of A-PRF to bone grafts has been reported to enhance the process of bone regeneration through different mechanisms.
- Ridge augmentation according to the principle of GBR using collagen membrane and bone graft has been proven to be predictable in producing significant bone gain promoting implant placement.
- The aim of the study is to clinically evaluate vertical bone gain in buccal peri-implant dehiscence and fenestration defects following application of advanced PRF plus xenograft compared to guided bone regeneration using collagen membrane and xenograft.
Surgical procedure:
- Control group: (Implant placement with xenograft and collagen membrane) After Para crestal incision and raising the mucoperiosteal flap at the top of the alveolar process, the exact position of the dental implant will be defined as determined by preoperative measurements, dental setup, and surgical guide. Bone level implants will be placed 3 mm apical to the expected cervical border of the crown.
The titanium surface of the dental implant will be covered with bone graft (xenograft), and coverage with a resorbable collagen membrane.
-Test group: (implant placement with xenograft and A-PRF) The alveolar bone exposure and implant osteotomy will be prepared and inserted in same manner as in the control group. The titanium surface of the dental implant will be covered with A-PRF and xenograft.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment * A Randomized clinical trial * Parallel study group * A trial will be carried out in outpatient clinic of Periodontology Department ,Faculty of Dentistry , Cairo University . * Equal randomization with equal probabilities for intervention. * Positive controlled : Both groups will receive treatment
| Arm | Type | Receives |
|---|---|---|
| Xenograft and Collagen membrane | Active comparator | Procedure: Xenograft and Collagen membranePlacing the implant with collagen membrane and xenograft at esthetic zone of maxillary ridge when 2-4 mm of implant threads exposure . |
| Xenograft and A-PRF | Experimental | Procedure: Xenograft and APRFPlacing the implant with xenograft and A-PRF at esthetic zone of maxillary ridge when 2-4 mm of implant threads exposure . |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- At least 18 years old.
- Systemically healthy.
- Has good dental health.
- Missing a single tooth in the maxillary anterior and premolar region
- Crestal residual ridge width of 4-5mm.
Key exclusion criteria (5 listed)
- Severe parafunctional habits, for example, bruxing and clenching.
- Conditions that complicate wound healing, for example, uncontrolled diabetes (defined as HBA1c level >7%) or smoking.
- Conditions that might lead to a possibly lowered regenerative capacity of the bone, for example, osteoporosis and Paget's disease.
- Pregnant or expecting to be pregnant.
- History of drug and alcohol abuse or certain medications like bisphosphonates or steroids currently or within the past three months.
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 |
|---|---|---|
| Xenograft and Collagen membranePlacing the implant with collagen membrane and xenograft at esthetic zone of maxillary ridge with 2-4 mm thread exposure . | Procedure or surgery | Xenograft and Collagen membrane |
| Xenograft and APRFPlacing the implant with APRF and xenograft at esthetic zone of maxillary ridge with 2-4 mm thread exposure . | Procedure or surgery | Xenograft and A-PRF |
Primary outcome
vertical buccal bone gain
Time frame: 6 months
It will be measured using UNC Periodontal probe
3 secondary outcomes
horizontal bone gain
Time frame: 6 months
Ridge width
Time frame: 6 months
Post-surgical patient satisfaction
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2019.
- Individual participant dataSharing planned: No
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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.
Abdallah M Shbair, B.D.S principal investigator
Dr
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Xenograft and Collagen membrane and Xenograft and APRF in people with Bone Loss, Alveolar, 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 7 inclusion and 5 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 16 May 2019. 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 Abdallah W Shabir, B.D.S (01281855966, abdallah.w.shbair@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
vertical buccal bone 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 16 May 2019; AzTrials last refreshed its copy on 3 Nov 2026.