Edentulous Alveolar RidgeNCT05513170
Closed Sinus Tenting Using Densah Burs Osteotomy Versus Conventional Osteotomy in Localized Pneumatization
A study testing Use of Densah Burs in closed sinus lift and Closed sinus lift using osteotomes in people with Edentulous Alveolar Ridge, run by Cairo University.
Trial summary
Isolated sinus pneumatization after single tooth extraction indicate sinus lifting for proper implant placement. The conventional way of using osteotomes to elevate the sinus is annoying to patient and also does not give the needed amount of bone around the implant. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Edentulous Alveolar Ridge
- What is being tested?
- Use of Densah Burs in closed sinus lift and Closed sinus lift using osteotomes
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2022to 1 Nov 2023
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- No inflamed sinus
- Minimum alveolar ridge height 5-6 mm
- Medical free
- Both genders males and females.
Who cannot join
- Remaining alveolar ridge height is less than 5mm
- Patients should not have taken drugs, especially bisphosphonates or drugs altering bone metabolism, within 2 months before the inclusion in the study.
- Subjected to irradiation in the head and neck area less than 1 year before implantation.
- Patients having history of allergy to any drugs.
- Patients who have a history of any concomitant from a major known medical problem and/or ongoing pharmacologic treatments
- Untreated periodontitis.
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- Poor oral hygiene and motivation.
- Uncontrolled diabetes.
- Pregnant or nursing.
- Substance abuse.
- Psychiatric problems or unrealistic expectations.
- Severe bruxism or clenching.
- Immunosuppressed or immunocompromised.
- Treated or under treatment with intravenous amino-bisphosphonates.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Graftless Closed Sinus Tenting Using Dental Implants After Densah Burs Osteotomy Versus Conventional Osteotomy in Localized Sinus Pneumatization: a Randomized Clinical Trial
Isolated sinus pneumatization after single tooth extraction indicate sinus lifting for proper implant placement. The conventional way of using osteotomes to elevate the sinus is annoying to patient and also does not give the needed amount of bone around the implant. Introducing new intervention of Densah Burs helps increase bone gain around implant and decrease the patient discomfort.
Read the detailed description
The rehabilitation of the edentulous posterior maxilla using osseointegrated implants is often challenging due alveolar bone resorption, low bone density and maxillary sinus pneumatization. Maxillary sinus lift is one of the most common surgical techniques used for increasing the available bone volume to place implants and restore function and esthetics. Trans-crestal approach can be successfully adopted when residual bone height is at least 5 mm. Osteotome sinus floor elevation was first in 1994, and proved to be less invasive, more conservative, less time consuming, and reduces postoperative discomfort to the patient. Moreover, this technique was found to yield predictable results with success rates of at least 95%.
Osseodensification is a new surgical technique of biomechanical bone preparation performed for dental implant placement where bone is compacted and auto grafted into open marrow spaces and osteotomy site walls in outwardly expanding directions. It was reported that osseodensification increases the bone-implant contact, bone density, and primary stability. Moreover, the insertion torque peak is directly related to implant primary stability and host bone density. Furthermore, for every 9.8 N cm of torque increased, a reduction in failure rate of 20% in single-tooth implant restoration was observed.
The objective of this study is to evaluate crestal sinus elevation using osseodensification versus osteotomy clinically and radiographically in terms of marginal bone loss, primary and secondary stability and bone gain around the implant.
- Conditions
- Edentulous Alveolar Ridge
- Being tested
- Use of Densah Burs in closed sinus lift, Closed sinus lift using osteotomes
- Keywords
- Densah Burs, Osteotomes, Sinus Tenting, Graftless
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of Densah Burs in closed sinus liftProcedure or surgery
Closed sinus will be performed using Densah Burs. Densah Burs enhance bone quality through osseodensification; a process through which bone is compacted and auto-graphted in the marrow spaces and apically to elevate the sinus floor and enhance bone density.
Closed sinus lift using osteotomesProcedure or surgery
Closed sinus lift will be performed using osteotomes. Osteotomes elevate the sinus floor and enhance the bone quality.
| Study group | Role | What they receive |
|---|---|---|
| Closed sinus lift using Densah bur | Active comparator | Closed sinus lifting will be performed using densah burs and then dental implants will be placed. Receives: Procedure: Closed sinus lift using osteotomes |
| Conventional closed sinus lift using osteotomes | Active comparator | Sinus lifting will be performed using osteotomes and then dental implants will be placed. Receives: Procedure: Use of Densah Burs in closed sinus lift |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of Bone Change in Cone Beam CT
The amount of bone change will be determined by superimposing pre-operative CBCT (cone-beam computed tomography), three months post-operative, and six months post-operative CBCT.
Measured: three and six months
Secondary outcomes (1)
Measurement of Primary and Secondary Implant stability using Resonance Frequency Analysis (RFA)
The implant stability quotient (ISQ) of the implants will be measured using a resonance frequency analysis measuring device, that is, Ostell, at the time of placement, which is the primary stability, and after six months, which is the secondary stability. The implant stability quotient has a scale ranging from 0 to 100 in which 0 is a failed implant and 100 is maximum implant stability.
Measured: At the day of implant placement and after six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2022
- Study start1 Sep 2022 (estimated)
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Edentulous Alveolar 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients' data will be enrolled in database of the Outpatient clinics of the Department of Oral and maxillofacial surgery, Faculty of Dentistry, Cairo University. If there is a potential eligibility, the patient will be examined thoroughly as described before. Consecutive sampling is done through screening of patients. This will continue until the target population is achieved. Identifying and recruiting potential subjects is achieved through patient database.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Basma Mohamed Abdelfatah Mohamed Shaheen, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05513170
- Sponsor's protocol ID
- Densah Burs
- Status last verified
- Aug 2022
- First submitted
- 27 Jun 2022
- Last updated
- 24 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ottoni JM, Oliveira ZF, Mansini R, Cabral AM. Correlation between placement torque and survival of single-tooth implants. Int J Oral Maxillofac Implants. 2005 Sep-Oct;20(5):769-76.
PubMed 16274152Summers RB. A new concept in maxillary implant surgery: the osteotome technique. Compendium. 1994 Feb;15(2):152, 154-6, 158 passim; quiz 162.
PubMed 8055503
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Graftless Closed Sinus Tenting Using Dental Implants After Densah Burs Osteotomy Versus Conventional Osteotomy in Localized Sinus Pneumatization: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05513170
- Acronym / sponsor ID
- Densah Burs
- Conditions
- Edentulous Alveolar Ridge
- Keywords
- Densah Burs, Osteotomes, Sinus Tenting, Graftless
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Nov 2023 (estimated)
- First posted
- 24 Aug 2022 (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.
Isolated sinus pneumatization after single tooth extraction indicate sinus lifting for proper implant placement. The conventional way of using osteotomes to elevate the sinus is annoying to patient and also does not give the needed amount of bone around the implant. Introducing new intervention of Densah Burs helps increase bone gain around implant and decrease the patient discomfort.
Detailed description
The rehabilitation of the edentulous posterior maxilla using osseointegrated implants is often challenging due alveolar bone resorption, low bone density and maxillary sinus pneumatization. Maxillary sinus lift is one of the most common surgical techniques used for increasing the available bone volume to place implants and restore function and esthetics. Trans-crestal approach can be successfully adopted when residual bone height is at least 5 mm. Osteotome sinus floor elevation was first in 1994, and proved to be less invasive, more conservative, less time consuming, and reduces postoperative discomfort to the patient. Moreover, this technique was found to yield predictable results with success rates of at least 95%.
Osseodensification is a new surgical technique of biomechanical bone preparation performed for dental implant placement where bone is compacted and auto grafted into open marrow spaces and osteotomy site walls in outwardly expanding directions. It was reported that osseodensification increases the bone-implant contact, bone density, and primary stability. Moreover, the insertion torque peak is directly related to implant primary stability and host bone density. Furthermore, for every 9.8 N cm of torque increased, a reduction in failure rate of 20% in single-tooth implant restoration was observed.
The objective of this study is to evaluate crestal sinus elevation using osseodensification versus osteotomy clinically and radiographically in terms of marginal bone loss, primary and secondary stability and bone gain around the implant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients' data will be enrolled in database of the Outpatient clinics of the Department of Oral and maxillofacial surgery, Faculty of Dentistry, Cairo University. If there is a potential eligibility, the patient will be examined thoroughly as described before. Consecutive sampling is done through screening of patients. This will continue until the target population is achieved. Identifying and recruiting potential subjects is achieved through patient database.
| Arm | Type | Receives |
|---|---|---|
| Closed sinus lift using Densah bur | Active comparator | Procedure: Closed sinus lift using osteotomesClosed sinus lifting will be performed using densah burs and then dental implants will be placed. |
| Conventional closed sinus lift using osteotomes | Active comparator | Procedure: Use of Densah Burs in closed sinus liftSinus lifting will be performed using osteotomes and then dental implants will be placed. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- No inflamed sinus
- Minimum alveolar ridge height 5-6 mm
- Medical free
- Both genders males and females.
Key exclusion criteria (14 listed)
- Remaining alveolar ridge height is less than 5mm
- Patients should not have taken drugs, especially bisphosphonates or drugs altering bone metabolism, within 2 months before the inclusion in the study.
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 |
|---|---|---|
| Use of Densah Burs in closed sinus liftClosed sinus will be performed using Densah Burs. Densah Burs enhance bone quality through osseodensification; a process through which bone is compacted and auto-graphted in the marrow spaces and apically to elevate the sinus floor and enhance bone density. | Procedure or surgery | Conventional closed sinus lift using osteotomes |
| Closed sinus lift using osteotomesClosed sinus lift will be performed using osteotomes. Osteotomes elevate the sinus floor and enhance the bone quality. | Procedure or surgery | Closed sinus lift using Densah bur |
Primary outcome
Measurement of Bone Change in Cone Beam CT
Time frame: three and six months
The amount of bone change will be determined by superimposing pre-operative CBCT (cone-beam computed tomography), three months post-operative, and six months post-operative CBCT.
1 secondary outcome
Measurement of Primary and Secondary Implant stability using Resonance Frequency Analysis (RFA)
Time frame: At the day of implant placement and after six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2022.
- Background: PubMed 16274152Ottoni JM, Oliveira ZF, Mansini R, Cabral AM. Correlation between placement torque and survival of single-tooth implants. Int J Oral Maxillofac Implants. 2005 Sep-Oct;20(5):769-76.
- Background: PubMed 8055503Summers RB. A new concept in maxillary implant surgery: the osteotome technique. Compendium. 1994 Feb;15(2):152, 154-6, 158 passim; quiz 162.
- Clinical and radiographic evaluation of osseodensification versus osteotome for sinus floor elevation in partially atrophic maxilla: A prospective long term studyLink provided by the sponsor.
- Primary Stability of Implant in Closed Sinus Lifting Cases Using Densah Bur Versus OsteotomeLink provided by the sponsor.
- Patient Perception and Radiographic Assessment of Sinus Lifting Procedure using Densah Bur versus Osteotome-mediated sinus lifting: A Randomized Clinical TrialLink provided by the sponsor.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Use of Densah Burs in closed sinus lift and Closed sinus lift using osteotomes in people with Edentulous Alveolar 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 4 inclusion and 14 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 24 Aug 2022. 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.
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 Eman M Anwar, Professor (+20223642705 ext. 522, rec@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of Bone Change in Cone Beam CT (time frame: three and six months). 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 NCT05513170, which also lists 2 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 24 Aug 2022.