An interventional study of Transalveolar crest maxillary sinus floor lift and transalveolar crest parietal maxillary sinus floor secondary lift in Tooth Loss, sponsored by Nanfang Hospital, Southern Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-26.
Sponsored by Nanfang Hospital, Southern Medical University · Not applicable, Interventional, and Treatment
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.
165 studies on the registry are indexed under Tooth Loss; 44 are open to participants now.
This study's planned enrollment of 40 is above the median of 30 across 120 interventional studies indexed under Tooth Loss.
Browse Tooth Loss studies →Nanfang Hospital, Southern Medical University is the lead sponsor of 490 studies on the registry; 214 are open to participants now.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Procedure: transalveolar crest parietal maxillary sinus floor secondary lift
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.
Procedure: Transalveolar crest maxillary sinus floor lift
Transalveolar crest maxillary sinus floor lift + bone grafting + implant implant is used
Transalveolar crest parietal maxillary sinus floor secondary lift + bone grafting + implant implantation were used body
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
Time frame: 3, 6, 12 months after implantation
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
Time frame: 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
Time frame: 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
Time frame: Preoperatively, 3, 6, 12 months after implantation
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Nanfang Hospital, Southern Medical University →