Atrophied Posterior MaxillaNCT03590964
One-stage Maxillary Sinus Elevation Using a Bone Core Containing an Implant From the Mandibular Symphysis
A study testing Open sinus lift using chin bone graft and Sinus lift using bone ring containing the implant. in people with Atrophied Posterior Maxilla, run by Cairo University at 1 site in Egypt.
Trial summary
Two groups of patients with atrophy in posterior maxilla indicated for sinus lift. First group will be subjected to open sinus lift with chin bone graft. Second group will be subjected to sinus floor elevation using a bone ring. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atrophied Posterior Maxilla
- What is being tested?
- Open sinus lift using chin bone graft and Sinus lift using bone ring containing the implant.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2018to 1 Aug 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with at least a unilateral atrophied posterior maxilla indicated for open sinus lift and graft.
- All ages and both sexes were included in this study.
- Patients should be free from any systemic disease that may affect normal healing of bone, and predictable outcome.
- Patients with good general condition allowing surgical procedure under general anesthesia.
- Patients with physical and psychological tolerance.
Who cannot join
- Patients with high risk systemic diseases like uncontrolled diabetes. As uncontrolled diabetes has a negative impact on normal bone healing.
- Patients with chronic sinusitis, maxillary sinus tumor or cyst. As they will affect accuracy of the procedure.
- Patients with physical and psychological intolerance. As psychological stress will affect the immune system and patient's fitness including healing capacity. ]
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Oral and Dental Medicine-Cairo University.
Cairo, Giza Governorate, 12613
Mohamed K Hassan, MSc, 01111284444, dr_mkdentistry@yahoo.com
About this study
Official title: One-stage Maxillary Sinus Elevation Using a Bone Core Containing an Implant From the Mandibular Symphysis: (A Randomized Controlled Trial)
Two groups of patients with atrophy in posterior maxilla indicated for sinus lift.
First group will be subjected to open sinus lift with chin bone graft. Second group will be subjected to sinus floor elevation using a bone ring.
Read the detailed description
Two groups of patients with atrophy in posterior maxilla indicated for sinus lift.
(A) First group will be subjected to open sinus lift with chin bone graft.
- All cases will undergo surgery under general anesthesia for sinus lift and other surgery under local anesthesia for implant placement .
- Exposure of the anterior wall of maxilla according to standardized surgical approach.
- Open sinus lift and bone graft.
- After 6 months, implant will be drilled and inserted in the recipient site according to standard protocol.
- Loading on implant after 5-6 months. (B)Second group will be subjected to sinus floor elevation using a bone ring.
- All cases will undergo surgery under local anesthesia for implant placement in the mandibular chin and other surgery under general anesthesia for sinus lift using bone ring with the implant.
- Exposure of the mandibular chin will be done under local anesthesia using a standardized surgical approach.
- Implant will be drilled and inserted in the chin according to standard protocol.
- After 3 months, second surgery under general anesthesia to place the implant and surrounding ring in the atrophied posterior maxilla.
- The bone ring containing the implant allowed to heal for 5-6 months.
Follow up:
- Clinical evaluation will be performed at the first week post-operative.
- Three months post-operative second surgery to put the implant with surrounding ring in atrophied posterior maxilla.
- Five months post-operative to the second surgery, implant will be loaded with the final restoration.
- Conditions
- Atrophied Posterior Maxilla
- Being tested
- Open sinus lift using chin bone graft, Sinus lift using bone ring containing the implant.
- Keywords
- Implant, Bone ring, Sinus lift.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open sinus lift using chin bone graftProcedure or surgery
Also called Lateral sinus approach with chin graft
Patients with atrophied posterior maxilla will undergo open sinus lift with chin bone graft according to standardized surgical approach.
Sinus lift using bone ring containing the implant.Procedure or surgery
Also called One stage sinus lift using bone ring
Patients with atrophied posterior maxilla will undergo sinus lift with chin bone ring containing the implant.
| Study group | Role | What they receive |
|---|---|---|
| Open sinus lift using chin bone graft | Active comparator | Patients with atrophied posterior maxilla will undergo open sinus lift with chin bone graft according to standardized surgical approach. Receives: Procedure: Open sinus lift using chin bone graft |
| Sinus lift using bone ring containing the implant | Experimental | Patients with atrophied posterior maxilla will undergo sinus lift using bone ring containing the implant. Receives: Procedure: Sinus lift using bone ring containing the implant. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival rate of implant
The estimated annual failure rate will be assessed via clinical assessment, measuring unit (Binary yes\ no)
Measured: One year post-operative.
Secondary outcomes (4)
Marginal bone loss around implant
Bone loss around implant will be assessed using Cone Beam Computed Tomography, measuring unit (millimeter).
Measured: one year post operative
Pain intensity
Intensity of pain will be assessed using Visual analog scale (0 -10), 0 indicate no pain,10 indicate unbearable pain.
Measured: One month post-operative.
Sinus membrane perforation
Perforation of sinus lining will be assessed clinically, (Binary yes\no).
Measured: During operation
Established bone integration
Structural and functional integration of bone around implant will be assessed using a device with measuring unit scale of 1-100.
Measured: Six months post operative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2018
- Study start1 Aug 2018 (estimated)
- Primary completion1 Aug 2019 (estimated)
- Study completion1 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Atrophied Posterior MaxillaStudies 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
- * A Randomized controlled trial. * Parallel group study. * A trial will be carried out in hospital of Oral and Maxillofacial surgery department- Faculty of Oral and Dental Medicine Cairo University * Equal randomization: participants with equal probabilities for intervention. * Positive controlled: Both groups receiving treatment.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed kamel hassan, Cairo University
- Investigators
- Salah Y yassin, PhD., Study director, Faculty of Oral and Dental Medicine- Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03590964
- Sponsor's protocol ID
- CEBD-CU-2018-07-05
- Status last verified
- Jul 2018
- First submitted
- 5 Jul 2018
- Last updated
- 18 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mahesh L, Kurtzman GM, Shukla S. Trephine core: an alternative sinus lift technique. J Oral Implantol. 2014 Jul;40 Spec No:391-6. doi: 10.1563/aaid-joi-D-14-00047. Epub 2014 Mar 12. No abstract available.
PubMed 24621196Wallace SS, Froum SJ. Effect of maxillary sinus augmentation on the survival of endosseous dental implants. A systematic review. Ann Periodontol. 2003 Dec;8(1):328-43. doi: 10.1902/annals.2003.8.1.328.
PubMed 14971260Pjetursson BE, Tan WC, Zwahlen M, Lang NP. A systematic review of the success of sinus floor elevation and survival of implants inserted in combination with sinus floor elevation. J Clin Periodontol. 2008 Sep;35(8 Suppl):216-40. doi: 10.1111/j.1600-051X.2008.01272.x.
PubMed 18724852Wang PD, Klein S, Kaufman E. One-stage maxillary sinus elevation using a bone core containing a preosseointegrated implant from the mandibular symphysis. Int J Periodontics Restorative Dent. 2002 Oct;22(5):435-9.
PubMed 12449303
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One-stage Maxillary Sinus Elevation Using a Bone Core Containing an Implant From the Mandibular Symphysis: (A Randomized Controlled Trial)
- ClinicalTrials.gov ID
- NCT03590964
- Acronym / sponsor ID
- CEBD-CU-2018-07-05
- Conditions
- Atrophied Posterior Maxilla
- Keywords
- Implant, Bone ring, Sinus lift.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Aug 2018 (estimated)
- Primary completion
- 1 Aug 2019 (estimated)
- Study completion
- 1 Aug 2019 (estimated)
- First posted
- 18 Jul 2018 (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.
Two groups of patients with atrophy in posterior maxilla indicated for sinus lift.
First group will be subjected to open sinus lift with chin bone graft. Second group will be subjected to sinus floor elevation using a bone ring.
Detailed description
Two groups of patients with atrophy in posterior maxilla indicated for sinus lift.
(A) First group will be subjected to open sinus lift with chin bone graft.
- All cases will undergo surgery under general anesthesia for sinus lift and other surgery under local anesthesia for implant placement .
- Exposure of the anterior wall of maxilla according to standardized surgical approach.
- Open sinus lift and bone graft.
- After 6 months, implant will be drilled and inserted in the recipient site according to standard protocol.
- Loading on implant after 5-6 months. (B)Second group will be subjected to sinus floor elevation using a bone ring.
- All cases will undergo surgery under local anesthesia for implant placement in the mandibular chin and other surgery under general anesthesia for sinus lift using bone ring with the implant.
- Exposure of the mandibular chin will be done under local anesthesia using a standardized surgical approach.
- Implant will be drilled and inserted in the chin according to standard protocol.
- After 3 months, second surgery under general anesthesia to place the implant and surrounding ring in the atrophied posterior maxilla.
- The bone ring containing the implant allowed to heal for 5-6 months.
Follow up:
- Clinical evaluation will be performed at the first week post-operative.
- Three months post-operative second surgery to put the implant with surrounding ring in atrophied posterior maxilla.
- Five months post-operative to the second surgery, implant will be loaded with the final restoration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- * A Randomized controlled trial. * Parallel group study. * A trial will be carried out in hospital of Oral and Maxillofacial surgery department- Faculty of Oral and Dental Medicine Cairo University * Equal randomization: participants with equal probabilities for intervention. * Positive controlled: Both groups receiving treatment.
| Arm | Type | Receives |
|---|---|---|
| Open sinus lift using chin bone graft | Active comparator | Procedure: Open sinus lift using chin bone graftPatients with atrophied posterior maxilla will undergo open sinus lift with chin bone graft according to standardized surgical approach. |
| Sinus lift using bone ring containing the implant | Experimental | Procedure: Sinus lift using bone ring containing the implant.Patients with atrophied posterior maxilla will undergo sinus lift using bone ring containing the implant. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with at least a unilateral atrophied posterior maxilla indicated for open sinus lift and graft.
- All ages and both sexes were included in this study.
- Patients should be free from any systemic disease that may affect normal healing of bone, and predictable outcome.
- Patients with good general condition allowing surgical procedure under general anesthesia.
- Patients with physical and psychological tolerance.
Key exclusion criteria (3 listed)
- Patients with high risk systemic diseases like uncontrolled diabetes. As uncontrolled diabetes has a negative impact on normal bone healing.
- Patients with chronic sinusitis, maxillary sinus tumor or cyst. As they will affect accuracy of the procedure.
- Patients with physical and psychological intolerance. As psychological stress will affect the immune system and patient's fitness including healing capacity. ]
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 |
|---|---|---|
| Open sinus lift using chin bone graftAlso: Lateral sinus approach with chin graftPatients with atrophied posterior maxilla will undergo open sinus lift with chin bone graft according to standardized surgical approach. | Procedure or surgery | Open sinus lift using chin bone graft |
| Sinus lift using bone ring containing the implant.Also: One stage sinus lift using bone ringPatients with atrophied posterior maxilla will undergo sinus lift with chin bone ring containing the implant. | Procedure or surgery | Sinus lift using bone ring containing the implant |
Primary outcome
Survival rate of implant
Time frame: One year post-operative.
The estimated annual failure rate will be assessed via clinical assessment, measuring unit (Binary yes\ no)
4 secondary outcomes
Marginal bone loss around implant
Time frame: one year post operative
Pain intensity
Time frame: One month post-operative.
Sinus membrane perforation
Time frame: During operation
Established bone integration
Time frame: Six months post operative.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2018.
- Results publication: PubMed 24621196Mahesh L, Kurtzman GM, Shukla S. Trephine core: an alternative sinus lift technique. J Oral Implantol. 2014 Jul;40 Spec No:391-6. doi: 10.1563/aaid-joi-D-14-00047. Epub 2014 Mar 12. No abstract available.
- Results publication: PubMed 14971260Wallace SS, Froum SJ. Effect of maxillary sinus augmentation on the survival of endosseous dental implants. A systematic review. Ann Periodontol. 2003 Dec;8(1):328-43. doi: 10.1902/annals.2003.8.1.328.
- Results publication: PubMed 18724852Pjetursson BE, Tan WC, Zwahlen M, Lang NP. A systematic review of the success of sinus floor elevation and survival of implants inserted in combination with sinus floor elevation. J Clin Periodontol. 2008 Sep;35(8 Suppl):216-40. doi: 10.1111/j.1600-051X.2008.01272.x.
- Results publication: PubMed 12449303Wang PD, Klein S, Kaufman E. One-stage maxillary sinus elevation using a bone core containing a preosseointegrated implant from the mandibular symphysis. Int J Periodontics Restorative Dent. 2002 Oct;22(5):435-9.
- Individual participant dataSharing planned: No
Related trials for Atrophied Posterior Maxilla
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Two-Stage Transcrestal Sinus Lift With Osseodensification: Allograft vs Autogenous-Xenograft
Severely Atrophic Posterior Maxilla
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Alveolar Ridge Preservation (ARP) in the Posterior Maxilla After the Extraction of Maxillary Molars
Alveolar Bone Loss
RecruitingPhase 2/3
Assessment of a New Enhanced Xenograft in Open Maxillary Sinus Augmentation
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Recruiting
Graftless TSFE Via Self-tapping Implants
Edentulous Posterior Maxilla, Maxillary Sinus Pneumatization
RecruitingObservational study
Digital Planning and Clinical Assessment of the Treated Atrophic Posterior Maxilla With a Sinus Lift Procedure: a Cross-sectional Study.
Alveolar Bone Atrophy, Alveolar Bone Grafting
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.
Salah Y yassin, PhD. study director
Faculty of Oral and Dental Medicine- Cairo 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 Open sinus lift using chin bone graft and Sinus lift using bone ring containing the implant. in people with Atrophied Posterior Maxilla, 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 3 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 18 Jul 2018. 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 K Hassan, MSc. (01111284444, dr_mkdentistry@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival rate of implant (time frame: One year post-operative.). 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 NCT03590964, which also lists 4 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 18 Jul 2018.