Sinus LiftNCT04625192
Trephine Osteotomy in Lateral Sinus Lift
A study testing Trephine osteotomy in people with Sinus Lift, run by Hams Hamed Abdelrahman at 1 site in Egypt.
Trial summary
Trephine osteotomy was used for lateral sinus lifting technique associated with sinus floor augmentation using the autogenous bone resulting from implant drilling using specialized trephine drills. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Sinus Lift
- What is being tested?
- Trephine osteotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2020to 30 Jan 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
- Patients of both genders requiring implant placement in the posterior maxilla.
- Age between 20-50 years.
- Tooth extractions at the implant sites were performed at least 4 months before surgery.
- Residual bone height between the alveolar bone crest and the sinus floor ranges from 4 to 6 mm.
- Patients who are willing and fully capable to comply with the study protocol
Who cannot join
- Maxillary sinus pathologies (sinusitis, long standing nasal obstruction)
- Any disease contraindicating surgery (e.g. uncontrolled diabetes)
- Heavy smokers
- Acute oral infections
- Poor oral hygiene
- A history of radiotherapy or chemotherapy of the head and neck region
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lateral Sinus Lift Technique Using Trephine Osteotomy With Simultaneous Implant Placement (Clinical Trial)
Trephine osteotomy was used for lateral sinus lifting technique associated with sinus floor augmentation using the autogenous bone resulting from implant drilling using specialized trephine drills.
Read the detailed description
The study includes 14 patients in whom the lateral sinus lift technique was performed using the trephine osteotomy with simultaneous implant placement.
Sinus floor augmentation with autogenous bone graft resulting from implant site preparation with trephine drills.
Implant stability and rate of complications such as Schneiderian membrane perforation and bleeding will be assessed.
Patients will also provide their subjective assessment of postoperative pain and swelling. Vertical bone height, that will be gained, will be assessed radiographically
- Conditions
- Sinus Lift
- Being tested
- Trephine osteotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trephine osteotomyProcedure or surgery
- Using a trephine on a straight implant handpiece (at approximately 1800 rpm) with copious irrigation to avoid overheating the bone, a round bone cut will be made 4 -5 mm above the crest of the alveolar ridge.
- The trephine is positioned perpendicular to the lateral wall, removing the outer cortex with a very gentle touch to avoid tearing the schneiderian membrane.
| Study group | Role | What they receive |
|---|---|---|
| Sinus lifting with trephine osteotomy | Experimental | Not described Receives: Procedure: Trephine osteotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Implant stability
This will be measured by implant stability meter (OsstellTM)
Measured: at baseline and 6 months
change in bone density
Panoramic radiography will be performed immediately postoperatively and cone beam computed tomography (CBCT)
Measured: at baseline, 3rd and 6th months
change in bone volume
Panoramic radiography will be performed immediately postoperatively and cone beam computed tomography (CBCT)
Measured: at baseline, 3rd and 6th months
change in bone vertical bone height
Panoramic radiography will be performed immediately postoperatively and cone beam computed tomography (CBCT)
Measured: at baseline, 3rd and 6th months
Secondary outcomes (2)
post operative pain
This will be assessed using a 10-point Visual Analogue Scale (VAS) in the 1st week postoperatively.
(0-1=None, 2-4=Mild-Moderate, 8-10= Severe)
Measured: after 1 week
Postoperative edema
- None (no inflammation).
- Mild (intraoral swelling confined to the surgical field).
- Moderate (extraoral swelling in the surgical zone).
- Severe (extraoral swelling spreading beyond the surgical zone
Measured: after 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2020
- Study start1 Feb 2020
- Primary completion30 Jan 2021 (estimated)
- Study completion30 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
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
- NCT04625192
- Sponsor's protocol ID
- Trephine osteotomy
- Status last verified
- Nov 2020
- First submitted
- 6 Nov 2020
- Last updated
- 12 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lateral Sinus Lift Technique Using Trephine Osteotomy With Simultaneous Implant Placement (Clinical Trial)
- ClinicalTrials.gov ID
- NCT04625192
- Acronym / sponsor ID
- Trephine osteotomy
- Conditions
- Sinus Lift
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Hams Hamed AbdelrahmanUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 30 Jan 2021 (estimated)
- Study completion
- 30 Jan 2021 (estimated)
- First posted
- 12 Nov 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.
Trephine osteotomy was used for lateral sinus lifting technique associated with sinus floor augmentation using the autogenous bone resulting from implant drilling using specialized trephine drills.
Detailed description
The study includes 14 patients in whom the lateral sinus lift technique was performed using the trephine osteotomy with simultaneous implant placement.
Sinus floor augmentation with autogenous bone graft resulting from implant site preparation with trephine drills.
Implant stability and rate of complications such as Schneiderian membrane perforation and bleeding will be assessed.
Patients will also provide their subjective assessment of postoperative pain and swelling. Vertical bone height, that will be gained, will be assessed radiographically
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sinus lifting with trephine osteotomy | Experimental | Procedure: Trephine osteotomy |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients of both genders requiring implant placement in the posterior maxilla.
- Age between 20-50 years.
- Tooth extractions at the implant sites were performed at least 4 months before surgery.
- Residual bone height between the alveolar bone crest and the sinus floor ranges from 4 to 6 mm.
- Patients who are willing and fully capable to comply with the study protocol
Key exclusion criteria (6 listed)
- Maxillary sinus pathologies (sinusitis, long standing nasal obstruction)
- Any disease contraindicating surgery (e.g. uncontrolled diabetes)
- Heavy smokers
- Acute oral infections
- Poor oral hygiene
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 |
|---|---|---|
| Trephine osteotomy* Using a trephine on a straight implant handpiece (at approximately 1800 rpm) with copious irrigation to avoid overheating the bone, a round bone cut will be made 4 -5 mm above the crest of the alveolar ridge. * The trephine is positioned perpendicular to the lateral wall, removing the outer cortex with a very gentle touch to avoid tearing the schneiderian membrane. | Procedure or surgery | Sinus lifting with trephine osteotomy |
Primary outcome
Change in Implant stability
Time frame: at baseline and 6 months
This will be measured by implant stability meter (OsstellTM)
change in bone density
Time frame: at baseline, 3rd and 6th months
Panoramic radiography will be performed immediately postoperatively and cone beam computed tomography (CBCT)
change in bone volume
Time frame: at baseline, 3rd and 6th months
Panoramic radiography will be performed immediately postoperatively and cone beam computed tomography (CBCT)
change in bone vertical bone height
Time frame: at baseline, 3rd and 6th months
Panoramic radiography will be performed immediately postoperatively and cone beam computed tomography (CBCT)
2 secondary outcomes
post operative pain
Time frame: after 1 week
Postoperative edema
Time frame: after 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trephine osteotomy in people with 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 5 inclusion and 6 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 12 Nov 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Implant stability (time frame: at baseline and 6 months). The study lists 4 primary outcomes in all. 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 12 Nov 2020.