Effect of Fixture Thread Depth on Accuracy of Immediate Implant Placement Using Dynamic Navigation

NCT06056388 | Unknown

• 1 other identifier: SDC-23-1
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to compare the placement accuracy in immediately placed implants using dynamic navigation between deep-threaded and regular-threaded implants in partially edentulous patients. The main question it aims to answer is: is there a difference in implant placement accuracy between deep-threaded and regular-threaded implants using dynamic navigation? Participants will receive implants placed immediately under dynamic guidance. Researchers will compare type of implant thread (Straumann BLT versus Straumann BLX) to see if there are significant differences in placement accuracy.

Conditions

Tooth Loss; Partial-edentulism

Keywords

Computer-Assisted Surgery; Dental Implants

Outcome Measures

Primary Outcomes (5)

• Placement accuracy measured as global platform deviation in millimeters and assessed by DCarer or coDiagnostiX

  Sufficiently described in the Title

  Postoperative (Day 1-5)

• Placement accuracy measured as lateral platform deviation in millimeters and assessed by DCarer or coDiagnostiX

  Sufficiently described in the Title

  Postoperative (Day 1-5)

• Placement accuracy measured as global apex deviation in millimeters and assessed by DCarer or coDiagnostiX

  Sufficiently described in the Title

  Postoperative (Day 1-5)

• Placement accuracy measured as apex depth deviations in millimeters and assessed by DCarer or coDiagnostiX

  Sufficiently described in the Title

  Postoperative (Day 1-5)

• Placement accuracy measured as angular deviation in degrees and assessed by DCarer or coDiagnostiX

  Sufficiently described in the Title

  Postoperative (Day 1-5)

Secondary Outcomes (7)

• Level of primary implant stability measured in insertion torque (ITV) using a Torq Control

  Intraoperative (Day 0)

• Level of primary implant stability measured in implant stability quotient (ISQ) using an Osstell Beacon

  Intraoperative (Day 0)

• Amount of radiographic bone-implant contact measured in millimeters using 3-matic Research

  Postoperative (Day 1-5)

• Amount of marginal bone loss measured in millimeters using periapical radiographs

  Postoperative (1 year)

• Rate of implant survival measured in percentage

  Postoperative (4 months & 1 year)

Study Arms (2)

Deep-threaded implants

ACTIVE COMPARATOR

Straumann BLX implants

Device: Straumann BLX implant

Regular-threaded implants

PLACEBO COMPARATOR

Straumann BLT implants

Device: Straumann BLT implant

Interventions

Straumann BLX implant DEVICE

Implant system with a deep fixture thread depth.

Deep-threaded implants

Straumann BLT implant DEVICE

Implant system with a regular fixture thread depth.

Regular-threaded implants

Eligibility Criteria

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

You may qualify if:

• Hopeless teeth that require extraction
• No systemic diseases
• Smoking (\<10 cigarettes/day)
• Full-mouth bleeding and full-mouth plaque index lower than or equal to 25%
• Fresh extraction sockets with at least 3 fully intact socket walls
• At least 4 mm of bone beyond the root apex
• Meets one of the following:
• Single immediate placement site in the maxillary esthetic zone \[15-25 (FDI classification)\].
• Two or more nonconsecutive immediate placement sites in the maxillary esthetic zone \[15-25 (FDI classification)\].
• Two or more consecutive immediate placement sites in the maxillary esthetic zone \[15-25 (FDI classification)\].

You may not qualify if:

• General medical (American Society of Anesthesiologists, ASA, class III or IV) and/or psychiatric contraindications
• Pregnancy or nursing
• Any interfering medication such as steroid therapy or bisphosphonate therapy
• Alcohol or drug abuse
• Heavy smoking (\>10 cigarettes/day)
• Radiation therapy to head or neck region within 5 years
• Untreated periodontitis
• Refuse to participate in this trial

Sponsors & Collaborators

• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University: lead

Related Publications (2)

• Skjerven H, Olsen-Bergem H, Ronold HJ, Riis UH, Ellingsen JE. Comparison of postoperative intraoral scan versus cone beam computerised tomography to measure accuracy of guided implant placement-A prospective clinical study. Clin Oral Implants Res. 2019 Jun;30(6):531-541. doi: 10.1111/clr.13438. Epub 2019 May 12.

  PMID: 31002415 RESULT

• Gu Y, Zhang D, Tao B, Wang F, Chen X, Wu Y. A novel technique to quantify bone-to-implant contact of zygomatic implants: a radiographic analysis based on three-dimensional image registration and segmentation. Dentomaxillofac Radiol. 2023 Jan;52(2):20220210. doi: 10.1259/dmfr.20220210. Epub 2023 Jan 16.

  PMID: 36645052 RESULT

MeSH Terms

Conditions

Tooth Loss

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases

Study Officials

• Yiqun Wu

  Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xinbo Yu

CONTACT

18019409340; xinboyu@proton.me

Study Design

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

Study Record Dates

• First Submitted: September 3, 2023
• First Posted: September 28, 2023
• Study Start: December 31, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: September 28, 2023

Record last verified: 2023-08