The Application of Root Analogy Implant in Immediate Implantation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-60
SponsorThe Dental Hospital of Zhejiang University School of Medicine
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
RAI
DeviceImmediate implantation
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: implanted groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Alveolar ridge height
The distance from the top of the alveolar ridge to the tip of the implant
Time frame
day 0,12 weeks,24weeks,48weeksSecondary outcomes
1
Width of alveolar ridge, buccal and lingual directions
The width of the implant platform from the buccal and lingual to the alveolar bone
Time frame
day 0，12 weeks, 24 weeks, 48 weeks2
Implant mobility
Measure the movement of the implant using an implant mobility meter and record the ISQ value
Time frame
day 0，12 weeks3
Gingival condition
Two independent clinical doctors conducted gingival examination in the oral implant area of the patient, and gave a comprehensive score for gingival condition based on changes in gingival color, shape, and texture. A 3-point scoring method was used, with good, average, and poor results.
Time frame
day 0, 12 weeks, 24 weeks, 48weeks4
Exploration depth and Exploring bleeding
Same periodontal probing. Use blunt head periodontal probing to measure the depth of probing at six points around the implant, including the buccal mesial, buccal central, buccal distal, lingual palatal mesial, lingual palatal central, and lingual palatal distal. Record the depth of probing and calculate the average value, 2-4mm if normal, if depth \>5mm, consider the occurrence of periimplantitis. The improved gingival sulcus bleeding index (mSBI) can be used to detect bleeding: 0=Along the periphery of the implant, no bleeding after soft tissue edge exploration; 1=scattered points after exploration, hemorrhage in shape; 2=After diagnosis, the bleeding appears linear in the groove; 3=severe or Spontaneous bleeding.
Time frame
12 weeks, 24 weeks, 48 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov