Evaluations, Diagnostic SelfNCT04659720
Clinical Evaluation of Stability of Dental Implant Placed Simultaneously With Closed Sinus Lifting Using Hydraulic Lift Technique Versus Summer's Osteotome Technique in Posterior Edentulous Maxilla (RCT)
A study testing Hydrolic lifter device and Patient satisfaction evalution using hydraulic lifter device in people with Evaluations, Diagnostic Self, run by Cairo University at 1 site in Egypt.
Trial summary
Clinical evaluation of stability of dental implant placed simultaneously with closed sinus lifting using hydraulic lift technique versus summer's osteotome technique in posterior edentulous maxilla (RCT) Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Evaluations, Diagnostic Self
- What is being tested?
- Hydrolic lifter device and Patient satisfaction evalution using hydraulic lifter device
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 27 Oct 2020to Nov 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 years and older
- 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 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 parafunctional 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: Clinical Evaluation of Stability of Dental Implant Placed Simultaneously With Closed Sinus Lifting Using Hydraulic Lift Technique Versus Summer's Osteotome Technique in Posterior Edentulous Maxilla (Randomized Clinical Trial)
Clinical evaluation of stability of dental implant placed simultaneously with closed sinus lifting using hydraulic lift technique versus summer's osteotome technique in posterior edentulous maxilla (RCT)
Read the detailed description
Clinical evaluation of stability of dental implant placed simultaneously with closed sinus lifting using hydraulic lift technique versus summer's osteotome technique in posterior edentulous maxilla (Randomised clinical trial)
- Conditions
- Evaluations, Diagnostic Self
- Being tested
- Hydrolic lifter device, Patient satisfaction evalution using hydraulic lifter device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrolic lifter deviceDevice
evaluation of implant stability after closed sinus lifting by hydraulic lift technique using hydraulic lifter device
Patient satisfaction evalution using hydraulic lifter deviceBehavioural
patients satisfaction will be evaluated numerically after using hydraulic lift technique by hydraulic lifter device for closed sinus lifting in posterior edentulous maxilla
| Study group | Role | What they receive |
|---|---|---|
| summers' osteotome technique for closed sinus lift | Active comparator | Implant stability will be evaluated after closed sinus lift using summer's osteotome technique in posterior edentulous maxilla Receives: Device: Hydrolic lifter device |
| Patient satisfaction evaluation after closed sinus lifting using summers' osteotome technique | Active comparator | * Will be assessed numerically using a patient satisfaction chart .
* Time of assessment: immediately after surgery Receives: Behavioral: Patient satisfaction evalution using hydraulic lifter device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant stability evaluation
Evaluation of implant stability after closed sinus lifting in posterior edentulous maxilla using osteotome technique versus hydraulic lift technique
Measured: Immediately after surgery
Secondary outcomes (1)
Patient satisfaction evaluation
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: Immediately after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2020
- Study start27 Oct 2020
- Primary completionAug 2021 (estimated)
- Study completionNov 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
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, Principal investigator, Assoc.professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04659720
- Sponsor's protocol ID
- 131020
- Status last verified
- Dec 2020
- First submitted
- 19 Nov 2020
- Last updated
- 9 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Up till now the strategy of sharing isnot decided
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Stability of Dental Implant Placed Simultaneously With Closed Sinus Lifting Using Hydraulic Lift Technique Versus Summer's Osteotome Technique in Posterior Edentulous Maxilla (Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT04659720
- Acronym / sponsor ID
- 131020
- Conditions
- Evaluations, Diagnostic Self
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 27 Oct 2020 (actual)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Nov 2021 (estimated)
- First posted
- 9 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.
Clinical evaluation of stability of dental implant placed simultaneously with closed sinus lifting using hydraulic lift technique versus summer's osteotome technique in posterior edentulous maxilla (RCT)
Detailed description
Clinical evaluation of stability of dental implant placed simultaneously with closed sinus lifting using hydraulic lift technique versus summer's osteotome technique in posterior edentulous maxilla (Randomised clinical trial)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| summers' osteotome technique for closed sinus lift | Active comparator | Device: Hydrolic lifter deviceImplant stability will be evaluated after closed sinus lift using summer's osteotome technique in posterior edentulous maxilla |
| Patient satisfaction evaluation after closed sinus lifting using summers' osteotome technique | Active comparator | Behavioral: Patient satisfaction evalution using hydraulic lifter device* Will be assessed numerically using a patient satisfaction chart . * Time of assessment: immediately after surgery |
Who may qualify
- Ages
- 20 years and older
- 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 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 parafunctional 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 |
|---|---|---|
| Hydrolic lifter deviceevaluation of implant stability after closed sinus lifting by hydraulic lift technique using hydraulic lifter device | Device | summers' osteotome technique for closed sinus lift |
| Patient satisfaction evalution using hydraulic lifter devicepatients satisfaction will be evaluated numerically after using hydraulic lift technique by hydraulic lifter device for closed sinus lifting in posterior edentulous maxilla | Behavioural | Patient satisfaction evaluation after closed sinus lifting using summers' osteotome technique |
Primary outcome
Implant stability evaluation
Time frame: Immediately after surgery
Evaluation of implant stability after closed sinus lifting in posterior edentulous maxilla using osteotome technique versus hydraulic lift technique
1 secondary outcome
Patient satisfaction evaluation
Time frame: Immediately after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2020.
- Individual participant dataSharing planned: Undecided. Up till now the strategy of sharing isnot decided
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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 principal investigator
Assoc.professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrolic lifter device and Patient satisfaction evalution 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 9 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?
Implant stability evaluation (time frame: Immediately after surgery). 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 9 Dec 2020.