Evaluations, Diagnostic SelfNCT04648514
Radiographic Evaluation of Bone Height Gain With Dental Implant Placed Simultaneously With Closed Sinus Lifting Using Hydraulic Lift Technique Versus Summers' Osteotome Technique in Posterior Edentulous Maxilla (RCT)
A study testing Using of hydraulic lifter device for closed sinus lifting and patient satisfaction evaluation after using hydraulic lifter device in people with Evaluations, Diagnostic Self, run by Cairo University at 1 site in Egypt.
Trial summary
Radiographic evaluation of bone height gain with dental implant placed simultaneously with closed sinus lifting using hydraulic lift technique versus summers' osteotome technique in posterior edentulous maxilla (RCT) Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Evaluations, Diagnostic Self
- What is being tested?
- Using of hydraulic lifter device for closed sinus lifting and patient satisfaction evaluation after using hydraulic lifter device
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2020to 30 Sep 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Edentulous patients in the maxillary posterior region .
- Patients in need to fixed restorations in posterior region .
- Patients with a healthy systemic conditions.(Apparently medically free)
- Patients with adequate inter-arch space for placement of the prosthetic part of the implant .
- Patients who had approximately 5-8 mm of available bone height between crest of bone and floor of sinus
- Both sexes.
Show all 9Show fewer
- Patients with Good oral hygiene
- Patients more than 20 years old
- Cooperative and motivated patients
Who cannot join
- Patients with local pathological defects related to posterior maxilla .
- Heavy smokers.
- Abnormal habits that may alter results such as alcoholism or parafuctional habits .
- Patients with systemic diseases that may affect normal healing.
- Patients with psychiatric problem
- Patients with history of recent radiation therapy to the head and neck area .
- Patients with aggressive periodontitis .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Radiographic Evaluation of Bone Height Gain With Dental Implant Placed Simultaneously With Closed Sinus Lifting Using Hydraulic Lift Technique Versus Summers' Osteotome Technique in Posterior Edentulous Maxilla (Randomized Clinical Trial)
Radiographic evaluation of bone height gain with dental implant placed simultaneously with closed sinus lifting using hydraulic lift technique versus summers' osteotome technique in posterior edentulous maxilla (RCT)
Read the detailed description
Evaluation will be done on the amount of bone height gain radiographically (using both panorama and CBCT) after placement of the dental implant simultaneously with closed sinus lifting using hydraulic lift technique versus summers' osteotome technique in patients with posterior edentulous maxilla (Randomized Clinical Trial)
- Conditions
- Evaluations, Diagnostic Self
- Being tested
- Using of hydraulic lifter device for closed sinus lifting, patient satisfaction evaluation after using hydraulic lifter device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Using of hydraulic lifter device for closed sinus liftingProcedure or surgery
Using of recent closed minimally invasive technique (hydraulic left technique) by hydraulic lifter device for closed sinus lifting then evaluation of the amount of bone height gain will be done radiographically (by panorama and CBCT) after implant placement for patients with posterior edentulous maxilla .
patient satisfaction evaluation after using hydraulic lifter deviceBehavioural
Evaluation of patient satisfaction numerically will be done after using hydraulic lift technique by hydraulic lifter device for closed sinus lifting in posterior edentulous maxilla
| Study group | Role | What they receive |
|---|---|---|
| Using of bone osteotomes for closed sinus lifting | Active comparator | Using of summers' osteotome technique by bone osteotomes for closed sinus lifting then evaluation the amount of bone height gain will be done radiographically (by panorama and CBCT) after implant placement in posterior edentulous maxilla . Receives: Procedure: Using of hydraulic lifter device for closed sinus lifting |
| Patient satisfaction evaluation after using bone osteotomes | Active comparator | Evaluation of patient satisfaction numerically will be done after using summers' osteotome technique by bone osteotomes for closed sinus lifting in posterior edentulous maxilla Receives: Behavioral: patient satisfaction evaluation after using hydraulic lifter device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of bone height change
Evaluation of the amount of bone height change radiographically after closed sinus lift simultaneously with implant placement using hydraulic lift technique versus summers' osteotome technique in posterior edentulous maxilla
Measured: 6 months
Secondary outcomes (1)
Patient satisfaction numerical questionnaire
Evaluation of patient satisfaction by using specific numerical questionnaire which depends on numerical scale after closed sinus lifting procedure with implant placement using hydraulic lift technique versus summers' osteotome technique in posterior edentulous maxilla .
The patient satisfaction numerical questionnaire include several questions to the patient and the patient will put a circle sign on the mark at which he or she feels to represent the answer .
The numerical scale is from 1 to 5 for each question (with total of 20 questions) :
- represents strongly disagree
- represents disagree
- represents neither agree or disagree
- represents agree
- represents strongly agree
The final score is out of 100 so, more higher scores represents more patient satisfaction and so, better outcome and less scores represents less patient satisfaction and so, worse outcome.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2020
- Study start1 Oct 2020
- Primary completion30 Aug 2021 (estimated)
- Study completion30 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Evaluations, Diagnostic SelfStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hassan Mohammad, Cairo University
- Investigators
- Hassan Abdelghany, PHD, Study director, Assoc.professor of oral and maxillofacial surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04648514
- Sponsor's protocol ID
- 7920
- Status last verified
- Nov 2020
- First submitted
- 15 Nov 2020
- Last updated
- 1 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiographic Evaluation of Bone Height Gain With Dental Implant Placed Simultaneously With Closed Sinus Lifting Using Hydraulic Lift Technique Versus Summers' Osteotome Technique in Posterior Edentulous Maxilla (Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT04648514
- Acronym / sponsor ID
- 7920
- Conditions
- Evaluations, Diagnostic Self
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 Aug 2021 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 1 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.
Radiographic evaluation of bone height gain with dental implant placed simultaneously with closed sinus lifting using hydraulic lift technique versus summers' osteotome technique in posterior edentulous maxilla (RCT)
Detailed description
Evaluation will be done on the amount of bone height gain radiographically (using both panorama and CBCT) after placement of the dental implant simultaneously with closed sinus lifting using hydraulic lift technique versus summers' osteotome technique in patients with posterior edentulous maxilla (Randomized Clinical Trial)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Using of bone osteotomes for closed sinus lifting | Active comparator | Procedure: Using of hydraulic lifter device for closed sinus liftingUsing of summers' osteotome technique by bone osteotomes for closed sinus lifting then evaluation the amount of bone height gain will be done radiographically (by panorama and CBCT) after implant placement in posterior edentulous maxilla . |
| Patient satisfaction evaluation after using bone osteotomes | Active comparator | Behavioral: patient satisfaction evaluation after using hydraulic lifter deviceEvaluation of patient satisfaction numerically will be done after using summers' osteotome technique by bone osteotomes for closed sinus lifting in posterior edentulous maxilla |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Edentulous patients in the maxillary posterior region .
- Patients in need to fixed restorations in posterior region .
- Patients with a healthy systemic conditions.(Apparently medically free)
- Patients with adequate inter-arch space for placement of the prosthetic part of the implant .
- Patients who had approximately 5-8 mm of available bone height between crest of bone and floor of sinus
Key exclusion criteria (7 listed)
- Patients with local pathological defects related to posterior maxilla .
- Heavy smokers.
- Abnormal habits that may alter results such as alcoholism or parafuctional habits .
- Patients with systemic diseases that may affect normal healing.
- Patients with psychiatric problem
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 |
|---|---|---|
| Using of hydraulic lifter device for closed sinus liftingUsing of recent closed minimally invasive technique (hydraulic left technique) by hydraulic lifter device for closed sinus lifting then evaluation of the amount of bone height gain will be done radiographically (by panorama and CBCT) after implant placement for patients with posterior edentulous maxilla . | Procedure or surgery | Using of bone osteotomes for closed sinus lifting |
| patient satisfaction evaluation after using hydraulic lifter deviceEvaluation of patient satisfaction numerically will be done after using hydraulic lift technique by hydraulic lifter device for closed sinus lifting in posterior edentulous maxilla | Behavioural | Patient satisfaction evaluation after using bone osteotomes |
Primary outcome
Amount of bone height change
Time frame: 6 months
Evaluation of the amount of bone height change radiographically after closed sinus lift simultaneously with implant placement using hydraulic lift technique versus summers' osteotome technique in posterior edentulous maxilla
1 secondary outcome
Patient satisfaction numerical questionnaire
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2020.
- 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.
Hassan Abdelghany, PHD study director
Assoc.professor of oral and maxillofacial surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Using of hydraulic lifter device for closed sinus lifting and patient satisfaction evaluation after using hydraulic lifter device in people with Evaluations, Diagnostic Self, 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 9 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 1 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?
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?
Amount of bone height change (time frame: 6 months). 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 1 Dec 2020.