Clinical trial NCT06449391: The Application of Root Analogy Implant in Immediate Implantation
Official title: A Clinical Exploratory Study of Root Analogy Implant
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dental Implantation
Dental Implants
Osseointegration
Keywords: root analogy implant
Immediate implantation
Lead sponsor: The Dental Hospital of Zhejiang University School of Medicine
Sponsor class: OTHER
First posted: 2024-06-10
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: 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. A 3D printed personalized root implant system jointly developed by Zhejiang University School of Medicine Affiliated Stomatology Hospital, Zhejiang University School of Mechanical Engineering, and Hangzhou Ya Natural Technology Co., Ltd. The implant part of this implant system is implanted into the bone using laser melting printing technology in additive manufacturing methods. The raw material is pure titanium powder, and research results in New Zealand white rabbits and beagles have confirmed that the implant has good bone bonding ability, which can shorten surgical time, reduce surgical frequency, compress implant cycle, restore chewing function, and other advantages. The relevant research results have been published in the top oral journal Journal of Dental Research, and the chemical composition and biological safety of the material have been tested by the Zhejiang Medical Device Inspection and Research Institute (test report number: Z20221903), Z20222527，G20233158）。 The base and other accessories are cut from titanium rods using conventional reduction manufacturing techniques.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Alveolar ridge height
timeFrame: day 0,12 weeks,24weeks,48weeks
Secondary outcomes:
measure: Width of alveolar ridge, buccal and lingual directions
timeFrame: day 0，12 weeks, 24 weeks, 48 weeks
measure: Implant mobility
timeFrame: day 0，12 weeks
measure: Gingival condition
timeFrame: day 0, 12 weeks, 24 weeks, 48weeks
measure: Exploration depth and Exploring bleeding
timeFrame: 12 weeks, 24 weeks, 48 weeks
measure: Clinical looseness of implants
timeFrame: 12 weeks, 24 weeks, 48 weeks
measure: Recovery of chewing function
timeFrame: 24 weeks, 48 weeks
measure: Aesthetic satisfaction
timeFrame: 24 weeks，48 weeks
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The Affiliated Stomatology Hospital, Zhejiang University School of Medicine
state: Zhejiang
Study officials:
References: