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

Primary Purpose

Tooth Loss, Partial-edentulism

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Straumann BLX implant
Straumann BLT implant
Sponsored by
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tooth Loss focused on measuring Computer-Assisted Surgery, Dental Implants

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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)]. Exclusion Criteria: 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Deep-threaded implants

    Regular-threaded implants

    Arm Description

    Straumann BLX implants

    Straumann BLT implants

    Outcomes

    Primary Outcome Measures

    Placement accuracy measured as global platform deviation in millimeters and assessed by DCarer or coDiagnostiX
    Sufficiently described in the Title
    Placement accuracy measured as lateral platform deviation in millimeters and assessed by DCarer or coDiagnostiX
    Sufficiently described in the Title
    Placement accuracy measured as global apex deviation in millimeters and assessed by DCarer or coDiagnostiX
    Sufficiently described in the Title
    Placement accuracy measured as apex depth deviations in millimeters and assessed by DCarer or coDiagnostiX
    Sufficiently described in the Title
    Placement accuracy measured as angular deviation in degrees and assessed by DCarer or coDiagnostiX
    Sufficiently described in the Title

    Secondary Outcome Measures

    Level of primary implant stability measured in insertion torque (ITV) using a Torq Control
    Sufficiently described in the Title
    Level of primary implant stability measured in implant stability quotient (ISQ) using an Osstell Beacon
    Sufficiently described in the Title
    Amount of radiographic bone-implant contact measured in millimeters using 3-matic Research
    Sufficiently described in the Title
    Amount of marginal bone loss measured in millimeters using periapical radiographs
    Sufficiently described in the Title
    Rate of implant survival measured in percentage
    Sufficiently described in the Title
    Number of participants with biological or technical complications
    Sufficiently described in the Title
    Level of patient satisfaction measured using the Short Form Patient Satisfaction Questionnaire
    Minimum value: 18; Maximum value: 90; Higher scores mean a better outcome

    Full Information

    First Posted
    September 3, 2023
    Last Updated
    September 20, 2023
    Sponsor
    Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06056388
    Brief Title
    Effect of Fixture Thread Depth on Accuracy of Immediate Implant Placement Using Dynamic Navigation
    Official Title
    Is the Accuracy of Immediate Implant Placement Using Dynamic Navigation Affected by Fixture Thread Depth?: A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 31, 2023 (Anticipated)
    Primary Completion Date
    December 31, 2024 (Anticipated)
    Study Completion Date
    December 31, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

    4. Oversight

    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

    5. Study Description

    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.
    Detailed Description
    The initial visit will comprise a thorough clinical examination and panoramic radiograph acquisition. Hopeless teeth resulting from trauma, periapical abscess, and periodontitis will be evaluated to see if extraction indications are met. When extraction indications were met, patients will be evaluated for suitable bone height for immediate implant placement. When bone height was suitable, patients will be asked to take a preoperative CBCT scan. After tooth condition and bone volume evaluations, patients with adequate bone volume for immediate implant placement will be enrolled and randomly assigned to one of two groups: deep-threaded or regular-threaded. The following implant placement accuracy parameters will be recorded using postoperative intraoral scanning superimposition: Global platform deviation (measured in millimeters), lateral platform deviation (measured in millimeters), global apex deviation (measured in millimeters), apex depth deviations (measured in millimeters), and angular deviation (measured in degrees). Primary implant stability will be measured immediately after implant insertion and measured in both insertion torque value and implant stability quotient. Radiographic bone-implant contact will be measured with a 3D implant model reconstruction method using coDiagnostiX and the contact area will be calculated using 3-matic Research as previously reported. Marginal bone loss will be measured using ImageJ with periapical radiographs taken 3 months and 1-year post-op. Implant survival will be monitored starting from the final prosthesis delivery onwards. Complications (biological, technical, and implant loss) will be recorded accordingly. Patient satisfaction will be documented with a Mandarin Chinese version of the Short Form Patient Satisfaction Questionnaire (PSQ-18) upon final prosthesis delivery.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tooth Loss, Partial-edentulism
    Keywords
    Computer-Assisted Surgery, Dental Implants

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Deep-threaded implants
    Arm Type
    Active Comparator
    Arm Description
    Straumann BLX implants
    Arm Title
    Regular-threaded implants
    Arm Type
    Placebo Comparator
    Arm Description
    Straumann BLT implants
    Intervention Type
    Device
    Intervention Name(s)
    Straumann BLX implant
    Intervention Description
    Implant system with a deep fixture thread depth.
    Intervention Type
    Device
    Intervention Name(s)
    Straumann BLT implant
    Intervention Description
    Implant system with a regular fixture thread depth.
    Primary Outcome Measure Information:
    Title
    Placement accuracy measured as global platform deviation in millimeters and assessed by DCarer or coDiagnostiX
    Description
    Sufficiently described in the Title
    Time Frame
    Postoperative (Day 1-5)
    Title
    Placement accuracy measured as lateral platform deviation in millimeters and assessed by DCarer or coDiagnostiX
    Description
    Sufficiently described in the Title
    Time Frame
    Postoperative (Day 1-5)
    Title
    Placement accuracy measured as global apex deviation in millimeters and assessed by DCarer or coDiagnostiX
    Description
    Sufficiently described in the Title
    Time Frame
    Postoperative (Day 1-5)
    Title
    Placement accuracy measured as apex depth deviations in millimeters and assessed by DCarer or coDiagnostiX
    Description
    Sufficiently described in the Title
    Time Frame
    Postoperative (Day 1-5)
    Title
    Placement accuracy measured as angular deviation in degrees and assessed by DCarer or coDiagnostiX
    Description
    Sufficiently described in the Title
    Time Frame
    Postoperative (Day 1-5)
    Secondary Outcome Measure Information:
    Title
    Level of primary implant stability measured in insertion torque (ITV) using a Torq Control
    Description
    Sufficiently described in the Title
    Time Frame
    Intraoperative (Day 0)
    Title
    Level of primary implant stability measured in implant stability quotient (ISQ) using an Osstell Beacon
    Description
    Sufficiently described in the Title
    Time Frame
    Intraoperative (Day 0)
    Title
    Amount of radiographic bone-implant contact measured in millimeters using 3-matic Research
    Description
    Sufficiently described in the Title
    Time Frame
    Postoperative (Day 1-5)
    Title
    Amount of marginal bone loss measured in millimeters using periapical radiographs
    Description
    Sufficiently described in the Title
    Time Frame
    Postoperative (1 year)
    Title
    Rate of implant survival measured in percentage
    Description
    Sufficiently described in the Title
    Time Frame
    Postoperative (4 months & 1 year)
    Title
    Number of participants with biological or technical complications
    Description
    Sufficiently described in the Title
    Time Frame
    Postoperative (Up to 1 year)
    Title
    Level of patient satisfaction measured using the Short Form Patient Satisfaction Questionnaire
    Description
    Minimum value: 18; Maximum value: 90; Higher scores mean a better outcome
    Time Frame
    Postoperative (4 months & 1 year)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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)]. Exclusion Criteria: 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Xinbo Yu
    Phone
    18019409340
    Email
    xinboyu@proton.me
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yiqun Wu
    Organizational Affiliation
    Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    31002415
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    36645052
    Citation
    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.
    Results Reference
    result

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

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