Short-term Observation on the Clinical Application Effect of Astra Tech Implant EV Short Implants for Maxillary Sinus Elevation

Short-term comparison of clinical application effects of Astra OsseoSpeed EV short implants and conventional implants for maxillary sinus elevation

Study Overview

• Status: Not yet recruiting
• Conditions: Missing Teeth
• Intervention / Treatment: Device: short implants (L=6.3mm); Procedure: short implants (L=8mm); Device: conventional implants (L=9mm)

Detailed Description

1. If the survival rate, marginal bone resorption , complications and patient satisfaction of the short implant group are comparable or better than those of the conventional implant group, then short implants can be regarded as an effective treatment option for insufficient alveolar bone in the posterior teeth area. Thus, in clinical practice, the investigators can utilize short implants combined with transcrestal sinus floor elevation, or even implant short implants to help patients with certain insufficient maxillary bone complete implant restoration without resorting to more complex, costly and more invasive external elevation surgery to increase the length of posterior teeth implants in the maxillary region.
2. If it is found that the short implant group has a higher incidence of complications or a lower long-term survival rate, further exploration of its indications and optimization of surgical strategies is required.

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: lin hu Wang, Doctoral; Phone Number: +8618086060633; Email: 316036445@qq.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 422202
      • No. 26, Shengli Street, Jiang'an District, Wuhan City, Hubei Province, China
      • Contact: lin hu Wang, Doctor's degree; Phone Number: +8618086060633; Email: 316036445@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Patients aged over 18 years old with at least one area of the posterior dental arch having insufficient alveolar bone height (3-6 mm)
• Patients are in good health and have no major systemic diseases such as diabetes or cardiovascular diseases, and no maxillary sinus lesions
• They are willing to undergo implant restoration treatment and can complete at least 3-year follow-up.

Exclusion Criteria:

• horizontal bone deficiency alveolar ridges,bone defects caused by tumor resection
• excessive tobacco use (more than 10 cigarettes per day)
• severe liver and kidney diseases
• history of radiotherapy and chemotherapy in the head and neck region
• uncontrolled diabetes
• active periodontal disease
• oral mucosal diseases in the treatment area or poor oral hygiene,
• PI > 70%

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: transcrestal sinus floor elevation

Device: short implants (L=6.3mm); Short-term clinical outcome of Astra OsseoSpeed EV short implants (L=6.3mm) for transcrestal sinus floor elevation; Procedure: short implants (L=8mm); Short-term clinical outcome of Astra OsseoSpeed EV short implants (L=8mm) for transcrestal sinus floor elevation; Device: conventional implants (L=9mm); conventional implants (L=9mm) in the posterior maxillary region for dental restoration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Various complications	the rate of Implant survival, swelling, pain, etc.	From having a tooth implant to one year after wearing the dentures

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
marginal bone resorption	Measure the changes in the bone height around the implant	one year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction	Very satisfied, satisfied, dissatisfied, the rate of dissatisfaction, etc.	From having a tooth implant to one year after wearing the dentures

Collaborators and Investigators

• Sponsor: Linhu Wang
• Collaborators: Dentsply Sirona Implants and Consumables

Study record dates

Study Major Dates

• Study Start (Estimated): December 10, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): July 30, 2028

Study Registration Dates

• First Submitted: November 22, 2025
• First Submitted That Met QC Criteria: December 6, 2025
• First Posted (Estimated): December 9, 2025

Study Record Updates

• Last Update Posted (Actual): December 16, 2025
• Last Update Submitted That Met QC Criteria: December 8, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Short implant; Maxillary sinus floor elevation
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Tooth Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Anodontia
• Other Study ID Numbers: WHZXKYL2025-123; I-AS-25-105 (Other Grant/Funding Number: DENTSPLY IH AB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Methods and Results
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No