Lateral Sinus LiftingNCT06130657
Volumetric Analysis of Maxillary Sinus After Guided Lateral Sinus Lift Procedure
A study testing Lateral Maxillary Sinus Floor Elevation using surgical guide and Lateral Maxillary Sinus Floor Elevation without surgical guide in people with Lateral Sinus Lifting and Dental Implant, run by Ahmed Zewail at 1 site in Egypt.
Trial summary
The purpose of this study is to present a guided lateral window sinus lift (GLSL) procedure with the aid of a fully digital workflow using surgical templates for window osteotomy preparation and implant placement. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lateral Sinus Lifting, Dental Implant
- What is being tested?
- Lateral Maxillary Sinus Floor Elevation using surgical guide and Lateral Maxillary Sinus Floor Elevation without surgical guide
- 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
- 29 Dec 2020to 1 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adult patients (over 18 years of age), without any systemic complication.
- Patients who need for dental implant in posterior maxilla with bone height below the maxillary sinus is < 6 mm.
- Non smokers or patients who smoked less than 11 cig/day Will be included.
Who cannot join
- Uncontrolled systemic diseases which affect bone healing.
- Presence of any pathology in the site of operation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Volumetric Analysis of Maxillary Sinus After Guided Lateral Sinus Lift Procedure With Simultaneous Implant Placement
The purpose of this study is to present a guided lateral window sinus lift (GLSL) procedure with the aid of a fully digital workflow using surgical templates for window osteotomy preparation and implant placement.
Read the detailed description
In Group 1; The surgical procedure began with the adaptation of a prefabricated guide to the surgical site, ensuring firm stabilization. Implant positions were marked, and after the removal of the guide, a crestal incision was made. A mucoperiosteal flap was reflected, exposing the maxillary sinus and alveolar crest. The guide was readapted, marking implant positions, and a lateral window was formed using a bur or piezotome. Sinus membrane elevation was performed carefully. Implants were placed with graft material beneath the elevated membrane. In cases of bony plate preservation, the window was covered. In Group 2 (Lateral Maxillary Sinus Floor Elevation without a surgical guide), a crestal incision and mucoperiosteal flap exposed the sinus. A bony window was created, and careful elevation of the sinus floor followed. Implant osteotomies were completed, and graft material was packed into the sinus. A resorbable membrane was applied, and the flap was sutured. NanoboneÒ was used as the standard graft material in both groups.
- Conditions
- Lateral Sinus Lifting, Dental Implant
- Being tested
- Lateral Maxillary Sinus Floor Elevation using surgical guide, Lateral Maxillary Sinus Floor Elevation without surgical guide
- Keywords
- Sinus lifting, Dental implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lateral Maxillary Sinus Floor Elevation using surgical guideProcedure or surgery
The surgical procedure begins with securing a prefabricated guide firmly to the surgical site. Implant positions are marked, and after guide removal, a crestal incision is made 1 mm palatal to the marked point, extending with sulcular and vertical incisions. A full-thickness mucoperiosteal flap is reflected to expose the maxillary sinus and alveolar crest. After readapting the surgical guide to the bone, implant positions are marked, and cutting edges are tracked. The lateral window is formed by extending and connecting mesial and distal borders, created using piezotome. The sinus membrane is carefully reflected and elevated with a surgical curette to avoid iatrogenic perforation. Implant fixtures are then placed using the identical surgical guide, followed by graft material placement beneath the elevated sinus membrane. If the bony plate is preserved, the lateral window is covered with the plate.
Lateral Maxillary Sinus Floor Elevation without surgical guideProcedure or surgery
The sinus's lateral wall is exposed through a crestal incision and a mucoperiosteal flap. A bony window is created, and upon its removability, the sinus floor is carefully elevated using sinus elevation curettes, taking care to avoid membrane perforation. In cases of perforation, a resorbable collagen membrane is applied to cover the hole. Implant osteotomies are then completed following the standard sequential placement protocol. Graft material, mixed with normal saline, is gently packed into the sinus to fill the cavity with bone substitute material and achieve the desired bone height. Finally, a resorbable membrane is placed on the outer surface of the window, and the flap is sutured for primary closure.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Lateral Maxillary Sinus Floor Elevation using surgical guide | Active comparator | Not described Receives: Procedure: Lateral Maxillary Sinus Floor Elevation using surgical guide |
| Group 2: Lateral Maxillary Sinus Floor Elevation without surgical guide | Active comparator | Not described Receives: Procedure: Lateral Maxillary Sinus Floor Elevation without surgical guide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maxillary sinus volume
In cubic centimetre (cm3)
Measured: Preoperative, Immediate postoperative, 6 Months
Secondary outcomes (2)
Bone Gain
Im Millimeter (mm)
Measured: Immediate postoperative, 6 Months
Implant stability
In implant stability quotient (ISQ)
Measured: Intra-operative, 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2023
- Study start29 Dec 2020
- Primary completion1 Feb 2023
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lateral Sinus LiftingStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahmed Zewail
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ahmed Zewail, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06130657
- Sponsor's protocol ID
- AUAREC202100012-06
- Status last verified
- Nov 2023
- First submitted
- 9 Nov 2023
- Last updated
- 14 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Volumetric Analysis of Maxillary Sinus After Guided Lateral Sinus Lift Procedure With Simultaneous Implant Placement
- ClinicalTrials.gov ID
- NCT06130657
- Acronym / sponsor ID
- AUAREC202100012-06
- Conditions
- Lateral Sinus Lifting, Dental Implant
- Keywords
- Sinus lifting, Dental implant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Ahmed ZewailUniversity, hospital or other
- Study start
- 29 Dec 2020 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 14 Nov 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.
The purpose of this study is to present a guided lateral window sinus lift (GLSL) procedure with the aid of a fully digital workflow using surgical templates for window osteotomy preparation and implant placement.
Detailed description
In Group 1; The surgical procedure began with the adaptation of a prefabricated guide to the surgical site, ensuring firm stabilization. Implant positions were marked, and after the removal of the guide, a crestal incision was made. A mucoperiosteal flap was reflected, exposing the maxillary sinus and alveolar crest. The guide was readapted, marking implant positions, and a lateral window was formed using a bur or piezotome. Sinus membrane elevation was performed carefully. Implants were placed with graft material beneath the elevated membrane. In cases of bony plate preservation, the window was covered. In Group 2 (Lateral Maxillary Sinus Floor Elevation without a surgical guide), a crestal incision and mucoperiosteal flap exposed the sinus. A bony window was created, and careful elevation of the sinus floor followed. Implant osteotomies were completed, and graft material was packed into the sinus. A resorbable membrane was applied, and the flap was sutured. NanoboneÒ was used as the standard graft material in both groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Lateral Maxillary Sinus Floor Elevation using surgical guide | Active comparator | Procedure: Lateral Maxillary Sinus Floor Elevation using surgical guide |
| Group 2: Lateral Maxillary Sinus Floor Elevation without surgical guide | Active comparator | Procedure: Lateral Maxillary Sinus Floor Elevation without surgical guide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy adult patients (over 18 years of age), without any systemic complication.
- Patients who need for dental implant in posterior maxilla with bone height below the maxillary sinus is < 6 mm.
- Non smokers or patients who smoked less than 11 cig/day Will be included.
Key exclusion criteria (2 listed)
- Uncontrolled systemic diseases which affect bone healing.
- Presence of any pathology in the site of operation.
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 |
|---|---|---|
| Lateral Maxillary Sinus Floor Elevation using surgical guideThe surgical procedure begins with securing a prefabricated guide firmly to the surgical site. Implant positions are marked, and after guide removal, a crestal incision is made 1 mm palatal to the marked point, extending with sulcular and vertical incisions. A full-thickness mucoperiosteal flap is reflected to expose the maxillary sinus and alveolar crest. After readapting the surgical guide to the bone, implant positions are marked, and cutting edges are tracked. The lateral window is formed by extending and connecting mesial and distal borders, created using piezotome. The sinus membrane is carefully reflected and elevated with a surgical curette to avoid iatrogenic perforation. Implant fixtures are then placed using the identical surgical guide, followed by graft material placement beneath the elevated sinus membrane. If the bony plate is preserved, the lateral window is covered with the plate. | Procedure or surgery | Group 1: Lateral Maxillary Sinus Floor Elevation using surgical guide |
| Lateral Maxillary Sinus Floor Elevation without surgical guideThe sinus's lateral wall is exposed through a crestal incision and a mucoperiosteal flap. A bony window is created, and upon its removability, the sinus floor is carefully elevated using sinus elevation curettes, taking care to avoid membrane perforation. In cases of perforation, a resorbable collagen membrane is applied to cover the hole. Implant osteotomies are then completed following the standard sequential placement protocol. Graft material, mixed with normal saline, is gently packed into the sinus to fill the cavity with bone substitute material and achieve the desired bone height. Finally, a resorbable membrane is placed on the outer surface of the window, and the flap is sutured for primary closure. | Procedure or surgery | Group 2: Lateral Maxillary Sinus Floor Elevation without surgical guide |
Primary outcome
Maxillary sinus volume
Time frame: Preoperative, Immediate postoperative, 6 Months
In cubic centimetre (cm3)
2 secondary outcomes
Bone Gain
Time frame: Immediate postoperative, 6 Months
Implant stability
Time frame: Intra-operative, 6 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 14 Nov 2023.
- Individual participant dataSharing planned: Yes
Related trials for Lateral Sinus Lifting
Not yet recruitingObservational study
Outcomes of Different Bone Graft Combinations for Maxillary Sinus Augmentation Procedure
Bone Grafting, Sinus Lifting
Recruiting
Evaluation of Lateral Sinus Floor Elevation Using Xenograft Versus L-PRF Block Combined With Xenograft
Sinus Floor Augmentation, Maxillary Sinus Floor Elevation
Recruiting
Guided Lateral Sinus Lifting Using Autologous Serum Albumin/Platelet-Rich Fibrin
Sinus Perforation, Dental Implant Failure Nos
Not yet recruiting
Prospective Study of Bone Augmentation With Lateral Sinus Lift and Osseointegration of Dental Implants
Atrophic Maxilla, Partial Edentulism
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 Lateral Maxillary Sinus Floor Elevation using surgical guide and Lateral Maxillary Sinus Floor Elevation without surgical guide in people with Lateral Sinus Lifting and Dental Implant, run by Ahmed Zewail 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 3 inclusion and 2 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 14 Nov 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?
Maxillary sinus volume (time frame: Preoperative, Immediate postoperative, 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 14 Nov 2023.