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Primary and Secondary Elevations of Maxillary Sinuses: a Prospective Clinical Study in the Posterior Maxillary Region

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06106321
Enrollment
40
Registered
2023-10-30
Start date
2024-04-07
Completion date
2025-12-31
Last updated
2024-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tooth Loss

Brief 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. 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.

Interventions

PROCEDURETransalveolar crest maxillary sinus floor lift

Transalveolar crest maxillary sinus floor lift + bone grafting + implant implant is used

PROCEDUREtransalveolar crest parietal maxillary sinus floor secondary lift

Transalveolar crest parietal maxillary sinus floor secondary lift + bone grafting + implant implantation were used body

Sponsors

Nanfang Hospital, Southern Medical University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Age≥ 18 years old 2. 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 3. Can be scanned with radiology equipment before and after surgery 4. RBH ≤ 5mm, alveolar ridge width ≥5mm, each implant site is measured on CBCT 5. During implant healing, there is no removable restoration at the implant site 6. No history of acute or chronic sinusitis disease, no history of maxillary sinus disease, and no history of previous maxillary sinus surgery 7. Be willing to sign informed consent and authorization form, and be able to return to the clinic on time

Exclusion criteria

1. Heavy smokers (10 cigarettes smoked ≥ day) 2. Uncontrolled diabetes (glycated hemoglobin \>7%), metabolic bone disease, autoimmune disease or other systemic diseases, the body can hardly withstand implant surgery 3. Mentally unable, pregnant or pregnant women 4. 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 5. Untreated periodontal disease, endodontics, or other oral diseases 6. Bruxism patients 7. Previous implant implant failure at the surgical site 8. 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)

Design outcomes

Primary

MeasureTime frameDescription
Neonatal bone mass in the sinus3, 6, 12 months after implantationThe 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

Secondary

MeasureTime frameDescription
Remaining alveolar ridge heightPreoperatively, 3, 6, 12 months after implantationCBCT 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
Maxillary sinus floor elevation height3, 6, 12 months after implantation3 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
Peri-implant marginal bone resorptionPreoperatively, 3, 6, 12 months after implantationCBCT 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

Countries

China

Contacts

Primary ContactQi Liu, Ph.D
liuqi0721@smu.edu.cn+86 020 62787153

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026