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

NCT06106321 | Recruiting

• 1 other identifier: NFEC-2023-358
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Tooth Loss

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Remaining alveolar ridge height

  Preoperatively, 3, 6, 12 months after implantation

• Maxillary sinus floor elevation height

  3, 6, 12 months after implantation

• Peri-implant marginal bone resorption

  Preoperatively, 3, 6, 12 months after implantation

Study Arms (2)

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.

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.

Procedure: Transalveolar crest maxillary sinus floor lift

Interventions

Transalveolar crest maxillary sinus floor lift PROCEDURE

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

Transalveolar crest parietal maxillary sinus floor lift

transalveolar crest parietal maxillary sinus floor secondary lift PROCEDURE

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

Transalveolar crest parietal maxillary sinus floor secondary lift

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

NanFang Hospital of Sourthern Medical University

Guangzhou, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Tooth Loss

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases

Central Study Contacts

Qi Liu, Ph.D

CONTACT

+86 020 62787153; liuqi0721@smu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2023
• First Posted: October 30, 2023
• Study Start: April 7, 2024
• Primary Completion: April 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 26, 2024

Record last verified: 2024-04

Locations

CN (1)