Maxillary SinusNCT05777239
Dental Implant Approach for Crestal Sinus Elevation; A Novel Technique.
A study testing Dental Implant Approach for Crestal Sinus Elevation in people with Maxillary Sinus and Dental Implant, run by Cairo University at 1 site in Egypt.
Trial summary
Vertical bone height reduction after extraction in the posterior maxilla is inevitable and complicates the treatment plan. Crestal sinus elevation, using implants and different grafting procedures are considered some of the proposed treatment protocols. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Maxillary Sinus, Dental Implant, Maxillary Sinus Lift
- What is being tested?
- Dental Implant Approach for Crestal Sinus Elevation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2020to 15 Feb 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who have at least one missing posterior maxillary tooth with sound adjacent teeth.
- Adults above the age of 18.
- Residual Bone height from 5mm to 7mm under the maxillary sinus assessed in CBCT.
- Mandibular posterior teeth opposing the tooth to be replaced for occlusion.
- Good oral hygiene.
- Patient accepts to provide an informed consent.
Who cannot join
- Smokers.
- Pregnant and lactating females.
- Medically compromised patients.
- Patients with active infection related at the site of implant/bone graft placement.
- Patients with untreated active periodontal diseases.
- Patients with parafunctional habits.
- Acute or chronic sinusitis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dental Implant Approach for Crestal Sinus Elevation; A Novel Technique. Case Series Study
Vertical bone height reduction after extraction in the posterior maxilla is inevitable and complicates the treatment plan. Crestal sinus elevation, using implants and different grafting procedures are considered some of the proposed treatment protocols. Ever since the introduction of implant dentistry and implant placement in the posterior maxilla has been a dilemma. The choice of the type of bone, anatomical landmarks and reduced remaining bone height are all obstacles faced when placing implants in this area. Vertical bone height reduction occurs post extraction of the maxillary molars and premolars by maxillary sinus pneumatization. Many protocols were suggested to overcome this phenomenon; placing short implants, 2nd premolar occlusion and finally maxillary sinus elevation.
A recent systematic review evaluated osteotomes mediated sinus floor elevation with or without grafting material. It concluded a high long term survival rate in both procedures, however only one comparative study was used in the analysis that involved 12 participants only. Another systematic review assessed the survival of implants placed with lateral versus crestal sinus approach in 4-8 mm ridge height. It concluded that the ability of the less invasive crestal sinus approach to replace one-stage lateral approach, however, only one randomized control trial was presented that involved 4o patients, and were followed-up for 5 years. This emphasizes the gap of knowledge in literature with high quality evidence concerning these approaches.
The purpose of the present study is to evaluate the radiographic vertical gain in bone height as well as the implant stability after implant placement without the use of bone grafts in posterior maxilla following sinus elevation using the crestal implant approach technique.
- Being tested
- Dental Implant Approach for Crestal Sinus Elevation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental Implant Approach for Crestal Sinus ElevationProcedure or surgery
Crestal Sinus Elevation by elevating the sinus membrane with a blunt ended dental implant approach
| Study group | Role | What they receive |
|---|---|---|
| Dental Implant Approach for Crestal Sinus Elevation | Experimental | Not described Receives: Procedure: Dental Implant Approach for Crestal Sinus Elevation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intrasinus bone formation around implant
CBCT mm
Measured: 1 year
Primary stability
torque measure
Measured: 1 day
Surgical complications
Clinical assessment (Yes/No)
Measured: 1 year
Implant Survival
Clinical assessment (Yes/No)
Measured: 1 year
Secondary outcomes (1)
prosthetic complications
Clinical assessment (Yes/No)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2023
- Study start1 Jan 2020
- Primary completion15 Nov 2022
- Study completion15 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maxillary SinusStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nesma Mohamed Fouad Shemais, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05777239
- Sponsor's protocol ID
- IDCE.N4
- Status last verified
- Mar 2023
- First submitted
- 3 Mar 2023
- Last updated
- 21 Mar 2023
- 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 21 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dental Implant Approach for Crestal Sinus Elevation; A Novel Technique. Case Series Study
- ClinicalTrials.gov ID
- NCT05777239
- Acronym / sponsor ID
- IDCE.N4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 15 Nov 2022 (actual)
- Study completion
- 15 Feb 2023 (actual)
- First posted
- 21 Mar 2023 (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.
Vertical bone height reduction after extraction in the posterior maxilla is inevitable and complicates the treatment plan. Crestal sinus elevation, using implants and different grafting procedures are considered some of the proposed treatment protocols. Ever since the introduction of implant dentistry and implant placement in the posterior maxilla has been a dilemma. The choice of the type of bone, anatomical landmarks and reduced remaining bone height are all obstacles faced when placing implants in this area. Vertical bone height reduction occurs post extraction of the maxillary molars and premolars by maxillary sinus pneumatization. Many protocols were suggested to overcome this phenomenon; placing short implants, 2nd premolar occlusion and finally maxillary sinus elevation.
A recent systematic review evaluated osteotomes mediated sinus floor elevation with or without grafting material. It concluded a high long term survival rate in both procedures, however only one comparative study was used in the analysis that involved 12 participants only. Another systematic review assessed the survival of implants placed with lateral versus crestal sinus approach in 4-8 mm ridge height. It concluded that the ability of the less invasive crestal sinus approach to replace one-stage lateral approach, however, only one randomized control trial was presented that involved 4o patients, and were followed-up for 5 years. This emphasizes the gap of knowledge in literature with high quality evidence concerning these approaches.
The purpose of the present study is to evaluate the radiographic vertical gain in bone height as well as the implant stability after implant placement without the use of bone grafts in posterior maxilla following sinus elevation using the crestal implant approach technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dental Implant Approach for Crestal Sinus Elevation | Experimental | Procedure: Dental Implant Approach for Crestal Sinus Elevation |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients who have at least one missing posterior maxillary tooth with sound adjacent teeth.
- Adults above the age of 18.
- Residual Bone height from 5mm to 7mm under the maxillary sinus assessed in CBCT.
- Mandibular posterior teeth opposing the tooth to be replaced for occlusion.
- Good oral hygiene.
Key exclusion criteria (7 listed)
- Smokers.
- Pregnant and lactating females.
- Medically compromised patients.
- Patients with active infection related at the site of implant/bone graft placement.
- Patients with untreated active periodontal diseases.
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 |
|---|---|---|
| Dental Implant Approach for Crestal Sinus ElevationCrestal Sinus Elevation by elevating the sinus membrane with a blunt ended dental implant approach | Procedure or surgery | Dental Implant Approach for Crestal Sinus Elevation |
Primary outcome
Intrasinus bone formation around implant
Time frame: 1 year
CBCT mm
Primary stability
Time frame: 1 day
torque measure
Surgical complications
Time frame: 1 year
Clinical assessment (Yes/No)
Implant Survival
Time frame: 1 year
Clinical assessment (Yes/No)
1 secondary outcome
prosthetic complications
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2023.
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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 Dental Implant Approach for Crestal Sinus Elevation in people with Maxillary Sinus and Dental Implant, 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 6 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: finished, as of the sponsor's last update on 21 Mar 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Intrasinus bone formation around implant (time frame: 1 year). 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 21 Mar 2023.