Atrophy; Edentulous RidgePhase 2/3NCT02836678
Bone Changes in Atrophic Maxilla Treated by Split-crest Technique
A Phase 2/3 study testing Ridge splitting, immediate implant, Nanobone with PRF. and Ridge splitting, immediate implantand PRF. in people with Atrophy; Edentulous Ridge, run by Cairo University.
Trial summary
The effect of adding Nanobone on horizontal bone gain in ridge splitting. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Atrophy; Edentulous Ridge
- What is being tested?
- Ridge splitting, immediate implant, Nanobone with PRF. and Ridge splitting, immediate implantand PRF.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Sep 2019
- Phase
- Phase 2/3
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: 18-70.
- Patients with an edentulous site in maxilla.
- Ridge width of <6mm at the edentulous site.
- Ridge height of >9mm at the edentulous site.
- Patients who are compliant to oral hygiene measures for 4 weeks.
- Patient consent approval and signing.
Who cannot join
- Smokers.
- Systemic disease that contraindicates implant placement or surgical procedures.
- No or poor patient's compliance.
- History of radio or chemo-therapy.
- Psychological problems.
- Pathology at the site of intervention.
- Pregnancy.
- Insufficient crown height space or mesio-distal dimension that contradict the placement of a dental implant.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Bone Changes in Atrophic Maxilla Treated by Split-crest Technique and Dental Implants With Platelet Rich Fibrin and Nanobone® Versus Platelet Rich Fibrin Alone; Randomized Controlled Trial
The effect of adding Nanobone on horizontal bone gain in ridge splitting.
Read the detailed description
In cases of a very narrow ridge, One of the augmentation protocols is alveolar ridge-splitting techniques (RST) or alveolar ridge expansion techniques with simultaneous implant insertion. The piezoelectric surgical devices implemented for conducting bone osteotomy through the use of micrometric ultrasonic vibrations have been widely used in recent years in maxillofacial surgery. Its biggest advantages are that it allows for cutting with micrometric sensitivity while cutting hard tissues, it offers a clear vision of the surgical site due to its cavitation effect, it does not cause any damage to the soft tissues while performing these cuts, and that the bone tissue heals more quickly and seamlessly, after the cuts made by piezosurgery device. The fully synthetic bone substitute, NanoBone® (Artoss, Rostock, Germany), which will be applied in this clinical study, is basically a nanocrystalline hydroxyapatite embedded in a silica gel matrix, achieved by means of specific sol-gel techniques. Features such as interconnecting pores on the nanoscale, the open SiOH or SiO groups of polysilicic acid, its large internal surface, and the high porosity of this biomaterial are all related to the calcification processes observed within the implantation bed. While the HA component is responsible for NanoBone osteoconductive properties, the silica component is believed to induce connective tissue formation, osteoblast proliferation, bone matrix mineralization, and calcification, thus combining osteoconductive and osteoinductive properties. This phenomenon is associated with the rearrangement of the silica matrix, which could be observed in vivo.
- Conditions
- Atrophy; Edentulous Ridge
- Being tested
- Ridge splitting, immediate implant, Nanobone with PRF., Ridge splitting, immediate implantand PRF.
- Medical subject headings
- Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ridge splitting, immediate implant, Nanobone with PRF.Biological
- Dental implant (is a surgical component that interfaces with the bone of the jaw or skull to support a dental prosthesis).
- Alloplast bone graft material (Nanobone)
- PRF platelet rich fibrin. (second-generation Platelet rich plasma where autologous platelets and leucocytes are present in a complex fibrin matrix to accelerate the healing of soft and hard tissue).
Ridge splitting, immediate implantand PRF.Biological
- Dental implant (is a surgical component that interfaces with the bone of the jaw or skull to support a dental prosthesis).
- PRF platelet rich fibrin. (second-generation Platelet rich plasma where autologous platelets and leucocytes are present in a complex fibrin matrix to accelerate the healing of soft and hard tissue).
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Ridge splitting, immediate implantand PRF. Receives: Biological: Ridge splitting, immediate implantand PRF. |
| Test group | Experimental | Ridge splitting, immediate implant, Nanobone with PRF. Receives: Biological: Ridge splitting, immediate implant, Nanobone with PRF. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Horizontal bone gain in millimeters
using Cone beam computed tomography
Measured: 5 month
Secondary outcomes (2)
Post-operative pain Using Numerical rating scale
Measured: 2 weeks
Post-operative swelling Using Descriptive 4-point scale of swelling
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2016 (estimated)
- Study startJan 2017
- Primary completionSep 2018 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Atrophy; Edentulous RidgeStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maged Wadie Anis, Cairo University
- Investigators
- Amr Zahran, Professor, Study chair, Professor of Oral Medicine, Periodontology and Oral DiagnosisAhmed Reda, Lecturer, Study director, Lecturer of Oral Medicine, Periodontology, and Oral Diagnosis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02836678
- Sponsor's protocol ID
- CEBD-2016-03-150
- Status last verified
- Jan 2017
- First submitted
- 11 Jul 2016
- Last updated
- 16 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Gerber, T., Holzhüter, G., Knoblich, B., Dörfling, P., Bienengräber, V., & Henkel, K. O. (2000). Development of bioactive sol-gel material template for in vitro and in vivo synthesis of bone material. Journal of Sol-Gel Science and Technology, 19(1-3), 441-445. http://doi.org/10.1023/A:10087995
Porter AE, Patel N, Skepper JN, Best SM, Bonfield W. Effect of sintered silicate-substituted hydroxyapatite on remodelling processes at the bone-implant interface. Biomaterials. 2004 Jul;25(16):3303-14. doi: 10.1016/j.biomaterials.2003.10.006.
PubMed 14980425Anis M, Abdelrahman AR, Attia R, Zahran A. Tomographic assessment of bone changes in atrophic maxilla treated by split-crest technique and dental implants with platelet-rich fibrin and NanoBone(R) versus platelet-rich fibrin alone: Randomized controlled trial. BMC Oral Health. 2024 Jun 14;24(1):691. doi: 10.1186/s12903-024-04420-5.
PubMed 38877464
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Changes in Atrophic Maxilla Treated by Split-crest Technique and Dental Implants With Platelet Rich Fibrin and Nanobone® Versus Platelet Rich Fibrin Alone; Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02836678
- Acronym / sponsor ID
- CEBD-2016-03-150
- Conditions
- Atrophy; Edentulous Ridge
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 19 Jul 2016 (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.
The effect of adding Nanobone on horizontal bone gain in ridge splitting.
Detailed description
In cases of a very narrow ridge, One of the augmentation protocols is alveolar ridge-splitting techniques (RST) or alveolar ridge expansion techniques with simultaneous implant insertion. The piezoelectric surgical devices implemented for conducting bone osteotomy through the use of micrometric ultrasonic vibrations have been widely used in recent years in maxillofacial surgery. Its biggest advantages are that it allows for cutting with micrometric sensitivity while cutting hard tissues, it offers a clear vision of the surgical site due to its cavitation effect, it does not cause any damage to the soft tissues while performing these cuts, and that the bone tissue heals more quickly and seamlessly, after the cuts made by piezosurgery device. The fully synthetic bone substitute, NanoBone® (Artoss, Rostock, Germany), which will be applied in this clinical study, is basically a nanocrystalline hydroxyapatite embedded in a silica gel matrix, achieved by means of specific sol-gel techniques. Features such as interconnecting pores on the nanoscale, the open SiOH or SiO groups of polysilicic acid, its large internal surface, and the high porosity of this biomaterial are all related to the calcification processes observed within the implantation bed. While the HA component is responsible for NanoBone osteoconductive properties, the silica component is believed to induce connective tissue formation, osteoblast proliferation, bone matrix mineralization, and calcification, thus combining osteoconductive and osteoinductive properties. This phenomenon is associated with the rearrangement of the silica matrix, which could be observed in vivo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Biological: Ridge splitting, immediate implantand PRF.Ridge splitting, immediate implantand PRF. |
| Test group | Experimental | Biological: Ridge splitting, immediate implant, Nanobone with PRF.Ridge splitting, immediate implant, Nanobone with PRF. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age: 18-70.
- Patients with an edentulous site in maxilla.
- Ridge width of <6mm at the edentulous site.
- Ridge height of >9mm at the edentulous site.
- Patients who are compliant to oral hygiene measures for 4 weeks.
Key exclusion criteria (8 listed)
- Smokers.
- Systemic disease that contraindicates implant placement or surgical procedures.
- No or poor patient's compliance.
- History of radio or chemo-therapy.
- Psychological problems.
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 |
|---|---|---|
| Ridge splitting, immediate implant, Nanobone with PRF.* Dental implant (is a surgical component that interfaces with the bone of the jaw or skull to support a dental prosthesis). * Alloplast bone graft material (Nanobone) * PRF platelet rich fibrin. (second-generation Platelet rich plasma where autologous platelets and leucocytes are present in a complex fibrin matrix to accelerate the healing of soft and hard tissue). | Biological | Test group |
| Ridge splitting, immediate implantand PRF.* Dental implant (is a surgical component that interfaces with the bone of the jaw or skull to support a dental prosthesis). * PRF platelet rich fibrin. (second-generation Platelet rich plasma where autologous platelets and leucocytes are present in a complex fibrin matrix to accelerate the healing of soft and hard tissue). | Biological | Control group |
Primary outcome
Horizontal bone gain in millimeters
Time frame: 5 month
using Cone beam computed tomography
2 secondary outcomes
Post-operative pain Using Numerical rating scale
Time frame: 2 weeks
Post-operative swelling Using Descriptive 4-point scale of swelling
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2017.
- BackgroundGerber, T., Holzhüter, G., Knoblich, B., Dörfling, P., Bienengräber, V., & Henkel, K. O. (2000). Development of bioactive sol-gel material template for in vitro and in vivo synthesis of bone material. Journal of Sol-Gel Science and Technology, 19(1-3), 441-445. http://doi.org/10.1023/A:10087995
- Background: PubMed 14980425Porter AE, Patel N, Skepper JN, Best SM, Bonfield W. Effect of sintered silicate-substituted hydroxyapatite on remodelling processes at the bone-implant interface. Biomaterials. 2004 Jul;25(16):3303-14. doi: 10.1016/j.biomaterials.2003.10.006.
- Derived from this study: PubMed 38877464Anis M, Abdelrahman AR, Attia R, Zahran A. Tomographic assessment of bone changes in atrophic maxilla treated by split-crest technique and dental implants with platelet-rich fibrin and NanoBone(R) versus platelet-rich fibrin alone: Randomized controlled trial. BMC Oral Health. 2024 Jun 14;24(1):691. doi: 10.1186/s12903-024-04420-5.
- Individual participant dataSharing planned: Undecided
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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.
Amr Zahran, Professor study chair
Professor of Oral Medicine, Periodontology and Oral Diagnosis
Ahmed Reda, Lecturer study director
Lecturer of Oral Medicine, Periodontology, and Oral Diagnosis
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ridge splitting, immediate implant, Nanobone with PRF. and Ridge splitting, immediate implantand PRF. in people with Atrophy; Edentulous Ridge, run by Cairo University.
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 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 16 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Maged Anis, Assisstant lecturer (00201000618605, magedwadie@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Horizontal bone gain in millimeters (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 NCT02836678, which also lists 3 linked publications.
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 Jan 2017.