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

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 Overview

• Status: Recruiting
• Conditions: Tooth Loss
• Intervention / Treatment: Procedure: transalveolar crest parietal maxillary sinus floor secondary lift; Procedure: Transalveolar crest maxillary sinus floor lift

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Qi Liu, Ph.D; Phone Number: +86 020 62787153; Email: liuqi0721@smu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • Recruiting
      • NanFang Hospital of Sourthern Medical University
      • Contact: Qi Liu, Ph.D; Phone Number: +86 020 62787153; Email: liuqi0721@smu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transalveolar crest parietal maxillary sinus floor secondary lift; 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 secondary lift + bone grafting + implant implantation were used body
Active Comparator: Transalveolar crest parietal maxillary sinus floor 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3, 6, 12 months after implantation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	Preoperatively, 3, 6, 12 months after implantation

Collaborators and Investigators

• Sponsor: Nanfang Hospital, Southern Medical University

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2024
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: October 24, 2023
• First Submitted That Met QC Criteria: October 24, 2023
• First Posted (Actual): October 30, 2023

Study Record Updates

• Last Update Posted (Actual): April 26, 2024
• Last Update Submitted That Met QC Criteria: April 24, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Tooth Diseases; Tooth Loss
• Other Study ID Numbers: NFEC-2023-358

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No