Alveolar Ridge AugmentationNCT06265467
Evaluation of Two Different Techniques for Sinus Elevation, Open Versus Closed .
A study testing Closed Sinus Elevation and Open Sinus Elevation in people with Alveolar Ridge Augmentation and Sinus Floor Augmentation, run by Misr International University at 1 site in Egypt.
Trial summary
A clinical Trial, comparing two different techniques to elevate the maxillary sinus floor membrane to allow for simultaneous dental implant placement in the severely atrophied maxillary ridges.Both using allogenic bone substitute as the bone graft material. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alveolar Ridge Augmentation, Sinus Floor Augmentation, Maxillary Sinus
- What is being tested?
- Closed Sinus Elevation and Open Sinus Elevation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2022to 1 Jul 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 18 years and older
- 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.
- Bone height from 4mm to 7mm under the maxillary sinus assessed in CBCT.
- Good oral hygiene.
- Patient accepts to sign an informed consent.
Who cannot join
- Smokers (more than 10 cigarettes per day).
- 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: Assessment of Implants Placed Simultaneously With Maxillary Sinus Bone Augmentation Using Two Different Sinus Elevation Techniques: A Randomized Control Clinical Trial
A clinical Trial, comparing two different techniques to elevate the maxillary sinus floor membrane to allow for simultaneous dental implant placement in the severely atrophied maxillary ridges.Both using allogenic bone substitute as the bone graft material. One technique is the open lateral window technique and the second is the closed crestal technique.
Read the detailed description
Following extraction of posterior teeth in the maxillary arch, maxillary sinus pneumatization may pause a difficulty for dental implant placement. This difficulty may be overcome by maxillary sinus elevation with or without bone grafting or the use of short implants. Yet the literature available does not give conclusive answers as to what is the best approach for each clinical situation.
Aim of this study is to evaluate implants placed simultaneously with maxillary sinus bone augmentation using two different sinus floor elevation techniques. Null Hypothesis: There is no statistically significant difference between implants placed with crestal sinus approach and lateral sinus floor elevation, using bone grafting in both techniques, regarding implant stability and radiographic bone height gain.
Alternative Hypothesis: There is statistically significant difference between implants placed with crestal sinus approach and lateral sinus floor elevation, using bone grafting in both techniques, regarding implant stability and radiographic bone height gain.
Thirty implants in patients having posterior edentulism with maxillary sinus pneumatization were studied. All patients were be randomly allocated into two groups, group 1 (test group) had dental implants placed after crestal approach for sinus elevation, while group 2 (control group) had dental implants placed after lateral approach for maxillary sinus elevation. Both groups received allogenic bone grafts in the elevated sites. To assess implant stability, a resonance frequency analysis (RFA) device was used, for each implant the implant stability quotient (ISQ) values was measured on four sites over the implant. Mean values were calculated for each implant from the four recorded values. ISQ values were recorded immediately post-implant insertion, 9 months (after delivery of the final prosthesis) and at 12 post- operative. Cone Beam Computed Tomography (CBCT)s were made at 6 and 12 months post-operative to evaluate the radiographic bone changes in vertical dimension of bone height gained around each implant.
Steps of the clinical Procedures:
- Clinical and radiographic evaluation:
- Evaluation of the patient's general condition of the oral cavity, to make sure it complies with the criteria required to be enrolled in the study in terms of oral hygiene, pathological conditions, occlusion and inter-arch space.
- A preoperative CBCT was performed for each patient prior to the surgery. Evaluation of available bone height and bucco-palatal bone width. Suitable implant length and diameter will be determined as well.
- Random allocation: The patients were divided into two groups with a random allocation sequence generator.
- Surgical procedure: After administration of local anesthesia, the allocation was revealed, for the test group, a full thickness flap was elevated at the edentulous site with two vertical releasing incision and then the preparation of osteotomy was prepared following standard implant system protocol preparation of the osteotomy. Drilling was done gently till reaching 0-1mm from the sinus floor, then in fracture of the sinus floor was done using osteotomes followed by bone grafting to raise the sinus floor from 3-5 mm and finally implant placement. For the control group, a full-thickness flap was elevated at the edentulous site with two vertical releasing incisions extending to the vestibule for better reflection and exposure to the lateral wall of the sinus. The lateral antrostomy was prepared in the lateral sinus wall using rotary bur no. 8 to provide adequate access to remove the thin to thick cortical bone and to expose the thin sinus membrane. The membrane was elevated across the sinus floor and up the medial wall and this elevation extended anteriorly-posteriorly to provide the exposed sinus floor. Drilling was done gently till reaching 0-1mm from the sinus floor, then implant placement and bone grafting took place. Primary stability of the implant was measured by rotational insertion torque value, to be ≥30 Nano centimeter(25). A resorbable collagen membrane was placed over the window preparation in the lateral approach to prevent the flap tissue from entering inside the antrostomy and the influencing the osseointegration process. Primary closure of the flap was achieved.
- Postoperative Care:
Appropriate postoperative care was given to the patients and proper medications prescribed to them.
Patient self-care instructions:
- Application of an ice pack to the treated area for the first 24 hours will be instructed.
- The patients will be instructed to gently brush the operated area after two weeks with a soft brush.
- In case of emergency; severe pain and bleeding, the patient will be presented to the clinic.
- Patients will be recalled after two weeks for suture removal and every month for supportive periodontal therapy and recording of outcome variables at six,nine and twelve months.
After 9 months of the implant placement, stage II will be performed, 2 weeks later, impressions will be taken as regular for the prosthetic crowns fabrication. All crowns will be temporary cemented to allow an easy access to the implant platform for the follow-up RFA measurements.
- Being tested
- Closed Sinus Elevation, Open Sinus Elevation
- Keywords
- Dental Implant, Maxillary Sinus Augmentation, Sinus Elevation, Open Sinus Elevation, Closed Sinus Elevation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closed Sinus ElevationProcedure or surgery
Also called Crestal approach to elevate the maxillary sinus membrane, Osteotome Technique
using a unique design of osteotomes to crestally elevate the Schneiderian membrane of the maxillary sinus floor
Open Sinus ElevationProcedure or surgery
Also called Lateral Approach to elevate the maxillary sinus Membrane
using a unique design of sinus elevators to laterally elevate the Schneiderian membrane of the maxillary sinus floor
| Study group | Role | What they receive |
|---|---|---|
| Test Group- Closed Sinus elevation | Experimental | Maxillary sinus floor elevation using osteotomes through a crestal approach. Followed by bone grafting using allogenic bone graft and simultaneous dental implant placement. Receives: Procedure: Closed Sinus Elevation |
| Control Group- Open sinus elevation | Active comparator | Maxillary sinus floor elevation using sinus elevation tools through a lateral window approach. Followed by bone grafting using allogenic bone graft and simultaneous dental implant placement. Receives: Procedure: Open Sinus Elevation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant Stability
Resonance Frequency analysis (RFA) a Device Named "Ostell" Device for measuring RFA
Measured: immediate postoperative- 9 months- 12 months
Secondary outcomes (1)
Radiographic bone gain
CBCT linear measurements using the ruler tool in the CBCT software to assess radiographic vertical bone height gain in millimeter in both techniques
Measured: immediate post-operative- 6 months-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start1 Jan 2022
- Primary completion1 Feb 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Ridge AugmentationStudies 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
- Model description
- Parallel Assignment
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Misr International University
- Sponsor type
- University, hospital or other
- Collaborators
- Suez Canal University
- Responsible party
- Principal investigator, Hebatallah Abdo's Elsaid Mattar, Misr International University
- Investigators
- Mohamed Elsholkamy, Professor, Study director, Suez Canal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06265467
- Sponsor's protocol ID
- 28909108800228
- Status last verified
- Feb 2024
- First submitted
- 9 Feb 2024
- Last updated
- 20 Feb 2024
- 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 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Implants Placed Simultaneously With Maxillary Sinus Bone Augmentation Using Two Different Sinus Elevation Techniques: A Randomized Control Clinical Trial
- ClinicalTrials.gov ID
- NCT06265467
- Acronym / sponsor ID
- 28909108800228
- Keywords
- Dental Implant, Maxillary Sinus Augmentation, Sinus Elevation, Open Sinus Elevation, Closed Sinus Elevation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Misr International UniversityUniversity, hospital or other
- Collaborators
- Suez Canal University
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 20 Feb 2024 (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.
A clinical Trial, comparing two different techniques to elevate the maxillary sinus floor membrane to allow for simultaneous dental implant placement in the severely atrophied maxillary ridges.Both using allogenic bone substitute as the bone graft material. One technique is the open lateral window technique and the second is the closed crestal technique.
Detailed description
Following extraction of posterior teeth in the maxillary arch, maxillary sinus pneumatization may pause a difficulty for dental implant placement. This difficulty may be overcome by maxillary sinus elevation with or without bone grafting or the use of short implants. Yet the literature available does not give conclusive answers as to what is the best approach for each clinical situation.
Aim of this study is to evaluate implants placed simultaneously with maxillary sinus bone augmentation using two different sinus floor elevation techniques. Null Hypothesis: There is no statistically significant difference between implants placed with crestal sinus approach and lateral sinus floor elevation, using bone grafting in both techniques, regarding implant stability and radiographic bone height gain.
Alternative Hypothesis: There is statistically significant difference between implants placed with crestal sinus approach and lateral sinus floor elevation, using bone grafting in both techniques, regarding implant stability and radiographic bone height gain.
Thirty implants in patients having posterior edentulism with maxillary sinus pneumatization were studied. All patients were be randomly allocated into two groups, group 1 (test group) had dental implants placed after crestal approach for sinus elevation, while group 2 (control group) had dental implants placed after lateral approach for maxillary sinus elevation. Both groups received allogenic bone grafts in the elevated sites. To assess implant stability, a resonance frequency analysis (RFA) device was used, for each implant the implant stability quotient (ISQ) values was measured on four sites over the implant. Mean values were calculated for each implant from the four recorded values. ISQ values were recorded immediately post-implant insertion, 9 months (after delivery of the final prosthesis) and at 12 post- operative. Cone Beam Computed Tomography (CBCT)s were made at 6 and 12 months post-operative to evaluate the radiographic bone changes in vertical dimension of bone height gained around each implant.
Steps of the clinical Procedures:
- Clinical and radiographic evaluation:
- Evaluation of the patient's general condition of the oral cavity, to make sure it complies with the criteria required to be enrolled in the study in terms of oral hygiene, pathological conditions, occlusion and inter-arch space.
- A preoperative CBCT was performed for each patient prior to the surgery. Evaluation of available bone height and bucco-palatal bone width. Suitable implant length and diameter will be determined as well.
- Random allocation: The patients were divided into two groups with a random allocation sequence generator.
- Surgical procedure: After administration of local anesthesia, the allocation was revealed, for the test group, a full thickness flap was elevated at the edentulous site with two vertical releasing incision and then the preparation of osteotomy was prepared following standard implant system protocol preparation of the osteotomy. Drilling was done gently till reaching 0-1mm from the sinus floor, then in fracture of the sinus floor was done using osteotomes followed by bone grafting to raise the sinus floor from 3-5 mm and finally implant placement. For the control group, a full-thickness flap was elevated at the edentulous site with two vertical releasing incisions extending to the vestibule for better reflection and exposure to the lateral wall of the sinus. The lateral antrostomy was prepared in the lateral sinus wall using rotary bur no. 8 to provide adequate access to remove the thin to thick cortical bone and to expose the thin sinus membrane. The membrane was elevated across the sinus floor and up the medial wall and this elevation extended anteriorly-posteriorly to provide the exposed sinus floor. Drilling was done gently till reaching 0-1mm from the sinus floor, then implant placement and bone grafting took place. Primary stability of the implant was measured by rotational insertion torque value, to be ≥30 Nano centimeter(25). A resorbable collagen membrane was placed over the window preparation in the lateral approach to prevent the flap tissue from entering inside the antrostomy and the influencing the osseointegration process. Primary closure of the flap was achieved.
- Postoperative Care:
Appropriate postoperative care was given to the patients and proper medications prescribed to them.
Patient self-care instructions:
- Application of an ice pack to the treated area for the first 24 hours will be instructed.
- The patients will be instructed to gently brush the operated area after two weeks with a soft brush.
- In case of emergency; severe pain and bleeding, the patient will be presented to the clinic.
- Patients will be recalled after two weeks for suture removal and every month for supportive periodontal therapy and recording of outcome variables at six,nine and twelve months.
After 9 months of the implant placement, stage II will be performed, 2 weeks later, impressions will be taken as regular for the prosthetic crowns fabrication. All crowns will be temporary cemented to allow an easy access to the implant platform for the follow-up RFA measurements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Test Group- Closed Sinus elevation | Experimental | Procedure: Closed Sinus ElevationMaxillary sinus floor elevation using osteotomes through a crestal approach. Followed by bone grafting using allogenic bone graft and simultaneous dental implant placement. |
| Control Group- Open sinus elevation | Active comparator | Procedure: Open Sinus ElevationMaxillary sinus floor elevation using sinus elevation tools through a lateral window approach. Followed by bone grafting using allogenic bone graft and simultaneous dental implant placement. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients who have at least one missing posterior maxillary tooth with sound adjacent teeth.
- Adults above the age of 18.
- Bone height from 4mm to 7mm under the maxillary sinus assessed in CBCT.
- Good oral hygiene.
- Patient accepts to sign an informed consent.
Key exclusion criteria (6 listed)
- Smokers (more than 10 cigarettes per day).
- 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.
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 |
|---|---|---|
| Closed Sinus ElevationAlso: Crestal approach to elevate the maxillary sinus membrane, Osteotome Techniqueusing a unique design of osteotomes to crestally elevate the Schneiderian membrane of the maxillary sinus floor | Procedure or surgery | Test Group- Closed Sinus elevation |
| Open Sinus ElevationAlso: Lateral Approach to elevate the maxillary sinus Membraneusing a unique design of sinus elevators to laterally elevate the Schneiderian membrane of the maxillary sinus floor | Procedure or surgery | Control Group- Open sinus elevation |
Primary outcome
Implant Stability
Time frame: immediate postoperative- 9 months- 12 months
Resonance Frequency analysis (RFA) a Device Named "Ostell" Device for measuring RFA
1 secondary outcome
Radiographic bone gain
Time frame: immediate post-operative- 6 months-12 months
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 20 Feb 2024.
- 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.
Mohamed Elsholkamy, Professor study director
Suez Canal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Closed Sinus Elevation and Open Sinus Elevation in people with Alveolar Ridge Augmentation and Sinus Floor Augmentation, run by Misr International 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 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: finished, as of the sponsor's last update on 20 Feb 2024. 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?
Implant Stability (time frame: immediate postoperative- 9 months- 12 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 20 Feb 2024.