The Application of Root Analogy Implant in Immediate Implantation

NCT06449391 | Recruiting

• 1 other identifier: 2024035
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The current clinical implant techniques used include immediate implantation, early implantation, and delayed implantation. With the acceleration of the current pace of life, immediate implantation is increasingly favored by patients due to its advantages such as fewer surgeries, shorter waiting times, and less impact on aesthetics. The research group has shown that the mismatch between traditional implants and extraction sockets in immediate implantation surgery has caused some complications. Therefore, it is believed that 3D printed personalized root shaped implants with certain roughness are more suitable for use in immediate implantation surgery.

Conditions

Dental Implantation; Dental Implants; Osseointegration

Keywords

root analogy implant; Immediate implantation

Outcome Measures

Primary Outcomes (1)

• Alveolar ridge height

  The distance from the top of the alveolar ridge to the tip of the implant

  day 0,12 weeks,24weeks,48weeks

Secondary Outcomes (7)

• Width of alveolar ridge, buccal and lingual directions

  day 0，12 weeks, 24 weeks, 48 weeks

• Implant mobility

  day 0，12 weeks

• Gingival condition

  day 0, 12 weeks, 24 weeks, 48weeks

• Exploration depth and Exploring bleeding

  12 weeks, 24 weeks, 48 weeks

• Clinical looseness of implants

  12 weeks, 24 weeks, 48 weeks

Study Arms (1)

implanted group

EXPERIMENTAL

This study is a single arm study, with only immediate implantation of root analogy implants

Device: RAI

Interventions

RAI DEVICE

Immediate implantation

implanted group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age:20-60 years old, gender unlimited
• Good oral hygiene
• No systemic diseases
• There are irreparable residual roots, no obvious apical periodontitis, no looseness greater than degree II, and the tooth position includes four quadrant anterior teeth and premolars
• Root length greater than 10 mm, and no significant bone resorption at the alveolar crest
• There is no significant displacement of adjacent teeth and no significant elongation of opposing teeth
• The bone density of the target implant area is Class II and Class III
• The lateral bone wall of the lips (cheeks), palate (tongue) is intact and larger than 1mm
• The subjects are able to understand the purpose of the experiment, willing to -cooperate with surgical treatment and follow-up, voluntarily participate in the experiment, and sign an informed consent form.

You may not qualify if:

• Patients with moderate to severe periodontitis
• Missing proximal and distal adjacent teeth in the target residual root
• Residual roots with root adhesion
• The target implant area has a bone density of Class I or IV
• Acute infectious disease or metabolic bone disease activity period
• Patients with diabetes history and poor blood glucose control (fasting blood glucose ≥ 8.8 mmol/L L)
• Patients with liver and kidney dysfunction (AST, ALT ≥ 1.5 times ULNULN, creatinine ≥ 1.5 times ULNULN)
• Individuals with a history of osteoporosis
• Individuals with a history of malignant tumors or other serious illnesses who are not suitable for surgery
• Individuals with mental disorders and lack of autonomous behavior ability Pregnant women, lactating or menstruating women, and women with pregnancy plans within six months
• Various possible causes of imaging artifacts in the surgical area
• Receiving medication that may affect bone metabolism (such as bisphosphonates) within the past 3 months
• The researchers estimate poor compliance or other factors that are not suitable for conducting this experiment.

Sponsors & Collaborators

• The Dental Hospital of Zhejiang University School of Medicine: lead

Study Sites (1)

The Affiliated Stomatology Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310006, China

RECRUITING

Central Study Contacts

Yixu Chen

CONTACT

+86 571 8721 9287; 11818293@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2024
• First Posted: June 10, 2024
• Study Start: April 1, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: June 10, 2024

Record last verified: 2024-06

Locations

CN (1)