Tooth LossNCT06106321
Primary and Secondary Elevations of Maxillary Sinuses: a Prospective Clinical Study in the Posterior Maxillary Region
A study testing Transalveolar crest maxillary sinus floor lift and transalveolar crest parietal maxillary sinus floor secondary lift in people with Tooth Loss, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
About 40 people will participate in the study, which will be conducted at Southern Medical University Southern Hospital. All subjects need to sign an informed consent form before screening, and successful subjects can enter the study. Experimental and control subjects were treated according to the protocol. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tooth Loss
- What is being tested?
- Transalveolar crest maxillary sinus floor lift and transalveolar crest parietal maxillary sinus floor secondary lift
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 7 Apr 2024to Dec 2025
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age≥ 18 years old
- If the posterior maxillary tooth is missing for ≥ 3 months, the patient requires implant restoration and the preoperative examination meets the indications for intramaxillary sinus lift
- Can be scanned with radiology equipment before and after surgery
- RBH ≤ 5mm, alveolar ridge width ≥5mm, each implant site is measured on CBCT
- During implant healing, there is no removable restoration at the implant site
- No history of acute or chronic sinusitis disease, no history of maxillary sinus disease, and no history of previous maxillary sinus surgery
- Be willing to sign informed consent and authorization form, and be able to return to the clinic on time
Who cannot join
- Heavy smokers (10 cigarettes smoked ≥ day)
- Uncontrolled diabetes (glycated hemoglobin >7%), metabolic bone disease, autoimmune disease or other systemic diseases, the body can hardly withstand implant surgery
- Mentally unable, pregnant or pregnant women
- Any history of contraindications or significant impact on dental implant placement, such as bisphosphonate drug use, chemotherapy or immunosuppressants, head and neck radiotherapy, autoimmune disease, and hypertension
- Untreated periodontal disease, endodontics, or other oral diseases
- Bruxism patients
- Previous implant implant failure at the surgical site
- Anatomical changes in the maxillary sinus, such as maxillary sinus septum or mucosal swelling (defined as the mean thickness of the Schneider membrane at the base of the maxillary sinus > 2 mm)
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
NanFang Hospital of Sourthern Medical University
Guangzhou, Guangdong
Qi Liu, Ph.D, +86 020 62787153, liuqi0721@smu.edu.cn
About this study
Official title: Transalveolar Crest Parietal Sinus Floor Lift and Secondary Lift for Postoperative Improvement of Neonatal Bone Mass in Sinus: a Prospective Clinical Study in the Posterior Maxillary Region
About 40 people will participate in the study, which will be conducted at Southern Medical University Southern Hospital. All subjects need to sign an informed consent form before screening, and successful subjects can enter the study. Experimental and control subjects were treated according to the protocol. Treatment was held until the participant entered a follow-up period, or until any of the withdrawal criteria were met. According to conventional clinical practice, the study needs to evaluate the patient's subjective perception and soft and hard tissue changes at 3 months, 6 months, and 1 year after successful implant placement. The specific process is divided into: 1. Screening period: All subjects need to complete the relevant examinations of the screening period before enrollment, and screen according to the admission criteria. (1) Sign informed consent; (2) Record demographic data: date of birth, gender, initials; (3) Medical history and physical examination: collection includes understanding of any current or past diseases, medications, drug allergy history, surgical history, radiotherapy and chemotherapy history, ethnic background, smoking history, whether alcoholism, oral hygiene habits and oral examination, etc.; (4) Among them, oral examination includes the whole oral health before and after surgery and oral and maxillofacial CBCT imaging examination; 2. Treatment period: the control group underwent transalveolar crest parietal maxillary sinus floor lift immediately after implants; The experimental group underwent implant implantation after 6 months of transalveolar crest parietal maxillary sinus floor lift. 3. Follow-up period: The study needs to evaluate the subjective feelings and soft and hard tissue changes of patients at 3 months, 6 months and 1 year after implant placement.
- Conditions
- Tooth Loss
- Being tested
- Transalveolar crest maxillary sinus floor lift, transalveolar crest parietal maxillary sinus floor secondary lift
- Medical subject headings
- Tooth Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transalveolar crest maxillary sinus floor liftProcedure or surgery
Transalveolar crest maxillary sinus floor lift + bone grafting + implant implant is used
transalveolar crest parietal maxillary sinus floor secondary liftProcedure or surgery
Transalveolar crest parietal maxillary sinus floor secondary lift + bone grafting + implant implantation were used body
| Study group | Role | What they receive |
|---|---|---|
| Transalveolar crest parietal maxillary sinus floor secondary lift | Experimental | In order to achieve minimally invasive surgery (RBH≤5mm) in patients with severe deficiency of residual bone height in the posterior maxillary region and obtain reliable clinical research results, a secondary sinus floor lifting technique combining the advantages of maxillary sinus lift with the low risk of maxillary sinus lift is proposed. Receives: Procedure: transalveolar crest parietal maxillary sinus floor secondary lift |
| Transalveolar crest parietal maxillary sinus floor lift | Active comparator | Transalveolar crest parietal maxillary sinus floor lift (OSFE) requires a residual bone height of at least 5 mm and implant placement at the same time. Its advantages are simple operation, shorter surgical time, reduced trauma and reduced postoperative complications, and the concept of minimally invasive implant surgery is reflected in OSFE. Receives: Procedure: Transalveolar crest maxillary sinus floor lift |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal bone mass in the sinus
The sum of bone mass (ABH) in the apical region and the elevation height (IPL) of the maxillary sinus floor (IPL) was measured by CBCT 3, 6, and 12 months after implantation
Measured: 3, 6, 12 months after implantation
Secondary outcomes (3)
Remaining alveolar ridge height
CBCT was used to measure the distance from the lowest coronal level of bone-implant contact to the apical level of bone-implant contact with sinus floor cortical bone
Measured: Preoperatively, 3, 6, 12 months after implantation
Maxillary sinus floor elevation height
3 months, 6 months, and 1 year after implantation, CBCT was used to measure the distance from the root tip of the implant to the cortical line of the sinus floor
Measured: 3, 6, 12 months after implantation
Peri-implant marginal bone resorption
CBCT was used to measure the difference between marginal bone level and marginal bone level baseline before surgery, 3 months, 6 months, and 1 year after implantation
Measured: Preoperatively, 3, 6, 12 months after implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start7 Apr 2024
- Primary completionApr 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth LossStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06106321
- Sponsor's protocol ID
- NFEC-2023-358
- Status last verified
- Apr 2024
- First submitted
- 24 Oct 2023
- Last updated
- 26 Apr 2024
- 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 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transalveolar Crest Parietal Sinus Floor Lift and Secondary Lift for Postoperative Improvement of Neonatal Bone Mass in Sinus: a Prospective Clinical Study in the Posterior Maxillary Region
- ClinicalTrials.gov ID
- NCT06106321
- Acronym / sponsor ID
- NFEC-2023-358
- Conditions
- Tooth Loss
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 7 Apr 2024 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 30 Oct 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.
About 40 people will participate in the study, which will be conducted at Southern Medical University Southern Hospital. All subjects need to sign an informed consent form before screening, and successful subjects can enter the study. Experimental and control subjects were treated according to the protocol. Treatment was held until the participant entered a follow-up period, or until any of the withdrawal criteria were met. According to conventional clinical practice, the study needs to evaluate the patient's subjective perception and soft and hard tissue changes at 3 months, 6 months, and 1 year after successful implant placement. The specific process is divided into: 1. Screening period: All subjects need to complete the relevant examinations of the screening period before enrollment, and screen according to the admission criteria. (1) Sign informed consent; (2) Record demographic data: date of birth, gender, initials; (3) Medical history and physical examination: collection includes understanding of any current or past diseases, medications, drug allergy history, surgical history, radiotherapy and chemotherapy history, ethnic background, smoking history, whether alcoholism, oral hygiene habits and oral examination, etc.; (4) Among them, oral examination includes the whole oral health before and after surgery and oral and maxillofacial CBCT imaging examination; 2. Treatment period: the control group underwent transalveolar crest parietal maxillary sinus floor lift immediately after implants; The experimental group underwent implant implantation after 6 months of transalveolar crest parietal maxillary sinus floor lift. 3. Follow-up period: The study needs to evaluate the subjective feelings and soft and hard tissue changes of patients at 3 months, 6 months and 1 year after implant placement.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transalveolar crest parietal maxillary sinus floor secondary lift | Experimental | Procedure: transalveolar crest parietal maxillary sinus floor secondary liftIn order to achieve minimally invasive surgery (RBH≤5mm) in patients with severe deficiency of residual bone height in the posterior maxillary region and obtain reliable clinical research results, a secondary sinus floor lifting technique combining the advantages of maxillary sinus lift with the low risk of maxillary sinus lift is proposed. |
| Transalveolar crest parietal maxillary sinus floor lift | Active comparator | Procedure: Transalveolar crest maxillary sinus floor liftTransalveolar crest parietal maxillary sinus floor lift (OSFE) requires a residual bone height of at least 5 mm and implant placement at the same time. Its advantages are simple operation, shorter surgical time, reduced trauma and reduced postoperative complications, and the concept of minimally invasive implant surgery is reflected in OSFE. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age≥ 18 years old
- If the posterior maxillary tooth is missing for ≥ 3 months, the patient requires implant restoration and the preoperative examination meets the indications for intramaxillary sinus lift
- Can be scanned with radiology equipment before and after surgery
- RBH ≤ 5mm, alveolar ridge width ≥5mm, each implant site is measured on CBCT
- During implant healing, there is no removable restoration at the implant site
Key exclusion criteria (8 listed)
- Heavy smokers (10 cigarettes smoked ≥ day)
- Uncontrolled diabetes (glycated hemoglobin >7%), metabolic bone disease, autoimmune disease or other systemic diseases, the body can hardly withstand implant surgery
- Mentally unable, pregnant or pregnant women
- Any history of contraindications or significant impact on dental implant placement, such as bisphosphonate drug use, chemotherapy or immunosuppressants, head and neck radiotherapy, autoimmune disease, and hypertension
- Untreated periodontal disease, endodontics, or other oral 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 |
|---|---|---|
| Transalveolar crest maxillary sinus floor liftTransalveolar crest maxillary sinus floor lift + bone grafting + implant implant is used | Procedure or surgery | Transalveolar crest parietal maxillary sinus floor lift |
| transalveolar crest parietal maxillary sinus floor secondary liftTransalveolar crest parietal maxillary sinus floor secondary lift + bone grafting + implant implantation were used body | Procedure or surgery | Transalveolar crest parietal maxillary sinus floor secondary lift |
Primary outcome
Neonatal bone mass in the sinus
Time frame: 3, 6, 12 months after implantation
The sum of bone mass (ABH) in the apical region and the elevation height (IPL) of the maxillary sinus floor (IPL) was measured by CBCT 3, 6, and 12 months after implantation
3 secondary outcomes
Remaining alveolar ridge height
Time frame: Preoperatively, 3, 6, 12 months after implantation
Maxillary sinus floor elevation height
Time frame: 3, 6, 12 months after implantation
Peri-implant marginal bone resorption
Time frame: Preoperatively, 3, 6, 12 months after implantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transalveolar crest maxillary sinus floor lift and transalveolar crest parietal maxillary sinus floor secondary lift in people with Tooth Loss, run by Nanfang Hospital, Southern Medical University at 1 site in China.
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 7 inclusion and 8 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 26 Apr 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 China. 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?
Contact Qi Liu, Ph.D (+86 020 62787153, liuqi0721@smu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neonatal bone mass in the sinus (time frame: 3, 6, 12 months after implantation). 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 26 Apr 2024.