Maxillary Sinus LiftNCT04688957
Osseodensification by Densah Burs Versus Osteotome
A study testing oseodensification sinus lifting and osteotome sinus lifting in people with Maxillary Sinus Lift, run by Hams Hamed Abdelrahman at 1 site in Egypt.
Trial summary
implant placement in the posterior maxilla is problematic, not only due to inferior properties of bone but also due to loss of vertical bone height which happens after extraction of posterior teeth. when the required additional height is few millimeters, indirect transcresta sinus lifting procedures are recommended. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Maxillary Sinus Lift
- What is being tested?
- oseodensification sinus lifting and osteotome sinus lifting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Dec 2020to 1 Aug 2021
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient with missing maxillary premolas and molars
- Vertical bone height of 5-8 mm
- Non smokers
- Good oral hygiene
Who cannot join
- Bad oral hygiene
- maxillary sinusitis
- Presence of infection or periapical lesions in adjacent teeth
- Bruxism or clenching
- Alcoholism
- Medically compromised patients with a condition that affect the procedure
- Multiple sinus septa
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University
Alexandria
Mohammed T Elghobashy, BDS, 01112158436 ext. 002, abotalaat20112371993@gmail.com
Mohammed T Elghobashy, BDS
About this study
Official title: Osseodensification by Densah Burs Versus Osteotome for Transcrestal Maxillary Sinus Lifting With Simultaneous Implant Placement (Randomized Clinical Trial)
implant placement in the posterior maxilla is problematic, not only due to inferior properties of bone but also due to loss of vertical bone height which happens after extraction of posterior teeth. when the required additional height is few millimeters, indirect transcresta sinus lifting procedures are recommended.
This study compares sinus lifting using the conventional osteotome versus the osseodensification with densah burs.
Read the detailed description
a total of 12 patients with missing maxillary premolars or molars and with limited vertical bone height below the maxillary sinus floor will receive implants either with osteotome or with Densah burs transcrestal sinus lifting to compare clinically and radiographically transcrestal sinus lifting with Densah burs and osteotome with simultaneous implant placement
- Conditions
- Maxillary Sinus Lift
- Being tested
- oseodensification sinus lifting, osteotome sinus lifting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oseodensification sinus liftingProcedure or surgery
application of first densah bur with densifying mood (reverse) counterclockwise, 1200 revolution per minute until the sinus is reached then use a wider densah bur with the same mode and bouncing motion to elevate the sinus floor up to 3 mm in 1mm increments.
osteotome sinus liftingProcedure or surgery
drilling implant site with consecutive drills short of the sinus floor by 1-2mm , using osteotome in appropriate size and application of one tap until sinus floor is elevated, using the final drill for the desired implant diameter
| Study group | Role | What they receive |
|---|---|---|
| osteotome sinus lifting | Active comparator | Not described Receives: Procedure: osteotome sinus lifting |
| oseodensification sinus lifting | Experimental | Not described Receives: Procedure: oseodensification sinus lifting |
What is being measured
The primary outcome is the main question the study is designed to answer.
implant stability
Using the Osstell, The result is presented as an ISQ value of 1-100. The higher the ISQ, the more stable the implant
Measured: at 6 months
change in bone height
using CBCT
Measured: at baseline and 6 months
change in bone density
using CBCT
Measured: at baseline and 6 months
Secondary outcomes (2)
Pain scores
10-point Visual Analogue Scale (VAS). (0-1= None, 2-4= Mild, 5-7= Moderate, 8-10= Severe)
Measured: at 2 weeks
edema scores
The pitting is graded on a scale of +1 to +4 as follows:
- +1 (trace) slight indentation rapid return to normal.
- +2 (mild) the indentation returns to normal in a few seconds.
- +3 (moderate) 6 mm indentation rebounds in 10-20 seconds.
- +4 (severe) 8 mm indentation rebounds in more than 30 seconds.
Measured: at 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2020
- Study start12 Dec 2020
- Primary completion1 Jul 2021 (estimated)
- Study completion1 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Maxillary Sinus LiftStudies 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
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hams Hamed Abdelrahman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hams Hamed Abdelrahman, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04688957
- Sponsor's protocol ID
- osseodensifcation
- Status last verified
- Dec 2020
- First submitted
- 18 Dec 2020
- Last updated
- 30 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Elghobashy MTM, Shaaban AM, Melek LNF. Radiographic comparison between Densah burs and osteotome for graftless internal sinus lifting with simultaneous implant placement: a randomized clinical trial. Int J Oral Maxillofac Surg. 2023 Mar;52(3):388-395. doi: 10.1016/j.ijom.2022.06.020. Epub 2022 Jul 13.
PubMed 35840446
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osseodensification by Densah Burs Versus Osteotome for Transcrestal Maxillary Sinus Lifting With Simultaneous Implant Placement (Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT04688957
- Acronym / sponsor ID
- osseodensifcation
- Conditions
- Maxillary Sinus Lift
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Hams Hamed AbdelrahmanUniversity, hospital or other
- Study start
- 12 Dec 2020 (actual)
- Primary completion
- 1 Jul 2021 (estimated)
- Study completion
- 1 Aug 2021 (estimated)
- First posted
- 30 Dec 2020 (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.
implant placement in the posterior maxilla is problematic, not only due to inferior properties of bone but also due to loss of vertical bone height which happens after extraction of posterior teeth. when the required additional height is few millimeters, indirect transcresta sinus lifting procedures are recommended.
This study compares sinus lifting using the conventional osteotome versus the osseodensification with densah burs.
Detailed description
a total of 12 patients with missing maxillary premolars or molars and with limited vertical bone height below the maxillary sinus floor will receive implants either with osteotome or with Densah burs transcrestal sinus lifting to compare clinically and radiographically transcrestal sinus lifting with Densah burs and osteotome with simultaneous implant placement
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| osteotome sinus lifting | Active comparator | Procedure: osteotome sinus lifting |
| oseodensification sinus lifting | Experimental | Procedure: oseodensification sinus lifting |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patient with missing maxillary premolas and molars
- Vertical bone height of 5-8 mm
- Non smokers
- Good oral hygiene
Key exclusion criteria (7 listed)
- Bad oral hygiene
- maxillary sinusitis
- Presence of infection or periapical lesions in adjacent teeth
- Bruxism or clenching
- Alcoholism
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 |
|---|---|---|
| oseodensification sinus liftingapplication of first densah bur with densifying mood (reverse) counterclockwise, 1200 revolution per minute until the sinus is reached then use a wider densah bur with the same mode and bouncing motion to elevate the sinus floor up to 3 mm in 1mm increments. | Procedure or surgery | oseodensification sinus lifting |
| osteotome sinus liftingdrilling implant site with consecutive drills short of the sinus floor by 1-2mm , using osteotome in appropriate size and application of one tap until sinus floor is elevated, using the final drill for the desired implant diameter | Procedure or surgery | osteotome sinus lifting |
Primary outcome
implant stability
Time frame: at 6 months
Using the Osstell, The result is presented as an ISQ value of 1-100. The higher the ISQ, the more stable the implant
change in bone height
Time frame: at baseline and 6 months
using CBCT
change in bone density
Time frame: at baseline and 6 months
using CBCT
2 secondary outcomes
Pain scores
Time frame: at 2 weeks
edema scores
Time frame: at 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2020.
- Derived from this study: PubMed 35840446Elghobashy MTM, Shaaban AM, Melek LNF. Radiographic comparison between Densah burs and osteotome for graftless internal sinus lifting with simultaneous implant placement: a randomized clinical trial. Int J Oral Maxillofac Surg. 2023 Mar;52(3):388-395. doi: 10.1016/j.ijom.2022.06.020. Epub 2022 Jul 13.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oseodensification sinus lifting and osteotome sinus lifting in people with Maxillary Sinus Lift, run by Hams Hamed Abdelrahman 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 4 inclusion and 7 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 30 Dec 2020. 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 Mohammed T Elghobashy, BDS (011121158436 ext. 002, abotalaat20112371993@gmil.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
implant stability (time frame: at 6 months). The study lists 3 primary outcomes in all. 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 NCT04688957, which also lists 1 linked publication.
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 30 Dec 2020.