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

Is the Accuracy of Immediate Implant Placement Using Dynamic Navigation Affected by Fixture Thread Depth?: A Randomized Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Tooth Loss; Partial-edentulism
• Intervention / Treatment: Device: Straumann BLX implant; Device: Straumann BLT implant

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xinbo Yu; Phone Number: 18019409340; Email: xinboyu@proton.me

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Deep-threaded implants; Straumann BLX implants	Device: Straumann BLX implant; Implant system with a deep fixture thread depth.
Placebo Comparator: Regular-threaded implants; Straumann BLT implants	Device: Straumann BLT implant; Implant system with a regular fixture thread depth.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of primary implant stability measured in insertion torque (ITV) using a Torq Control	Sufficiently described in the Title	Intraoperative (Day 0)
Level of primary implant stability measured in implant stability quotient (ISQ) using an Osstell Beacon	Sufficiently described in the Title	Intraoperative (Day 0)
Amount of radiographic bone-implant contact measured in millimeters using 3-matic Research	Sufficiently described in the Title	Postoperative (Day 1-5)
Amount of marginal bone loss measured in millimeters using periapical radiographs	Sufficiently described in the Title	Postoperative (1 year)
Rate of implant survival measured in percentage	Sufficiently described in the Title	Postoperative (4 months & 1 year)
Number of participants with biological or technical complications	Sufficiently described in the Title	Postoperative (Up to 1 year)
Level of patient satisfaction measured using the Short Form Patient Satisfaction Questionnaire	Minimum value: 18; Maximum value: 90; Higher scores mean a better outcome	Postoperative (4 months & 1 year)

Collaborators and Investigators

• Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
• Investigators: Principal Investigator: Yiqun Wu, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): December 31, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: September 3, 2023
• First Submitted That Met QC Criteria: September 20, 2023
• First Posted (Actual): September 28, 2023

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 20, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Dental Implants; Computer-Assisted Surgery
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Tooth Diseases; Tooth Loss
• Other Study ID Numbers: SDC-23-1

Drug and device information, study documents

• 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