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Status unknownNCT06056388Updated Sep 28, 2023

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

An interventional study of Straumann BLX implant and Straumann BLT implant in Tooth Loss and Partial-edentulism, sponsored by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-28.

Sponsored by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2023), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Tooth Loss
  • Partial-edentulism

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Keywords

  • Computer-Assisted Surgery
  • Dental Implants
03

In context

Tooth Loss

227 studies on the registry are indexed under Tooth Loss; 49 are open to participants now.

This study's planned enrollment of 30 is close to the median of 30 across 169 interventional studies indexed under Tooth Loss.

Browse Tooth Loss studies →

Lead sponsor

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University is the lead sponsor of 162 studies on the registry; 71 are open to participants now.

Browse Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Active comparator
    Deep-threaded implants

    Straumann BLX implants

    Device: Straumann BLX implant

  • Placebo comparator
    Regular-threaded implants

    Straumann BLT implants

    Device: Straumann BLT implant

Interventions

  • DeviceStraumann BLX implant

    Implant system with a deep fixture thread depth.

  • DeviceStraumann BLT implant

    Implant system with a regular fixture thread depth.

06

What researchers measure

Primary outcomes

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

    Sufficiently described in the Title

    Time frame: Postoperative (Day 1-5)

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

    Sufficiently described in the Title

    Time frame: Postoperative (Day 1-5)

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

    Sufficiently described in the Title

    Time frame: Postoperative (Day 1-5)

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

    Sufficiently described in the Title

    Time frame: Postoperative (Day 1-5)

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

    Sufficiently described in the Title

    Time frame: Postoperative (Day 1-5)

Secondary outcomes

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

    Sufficiently described in the Title

    Time frame: Intraoperative (Day 0)

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

    Sufficiently described in the Title

    Time frame: Intraoperative (Day 0)

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

    Sufficiently described in the Title

    Time frame: Postoperative (Day 1-5)

  4. Amount of marginal bone loss measured in millimeters using periapical radiographs

    Sufficiently described in the Title

    Time frame: Postoperative (1 year)

  5. Rate of implant survival measured in percentage

    Sufficiently described in the Title

    Time frame: Postoperative (4 months & 1 year)

  6. Number of participants with biological or technical complications

    Sufficiently described in the Title

    Time frame: Postoperative (Up to 1 year)

  7. Level of patient satisfaction measured using the Short Form Patient Satisfaction Questionnaire

    Minimum value: 18; Maximum value: 90; Higher scores mean a better outcome

    Time frame: Postoperative (4 months & 1 year)

07

Study locations

No study locations are listed for this record.

08

References and documents

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. PubMed 31002415 ↗
  • 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. PubMed 36645052 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Dec 2023; primary completion for Dec 2024, 12 months later.

Of 95 non-industry interventional studies with no phase under Tooth Loss, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 44. This study's planned 12 months is below that.

Counting every sponsor, half of 102 studies reached it within 23 months; a quarter within 12 and three quarters within 44.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 3, 2023
First posted
Sep 28, 2023
StartEst.
Dec 31, 2023
Primary completionEst.
Dec 31, 2024
CompletionEst.
Dec 31, 2025
Last update
Sep 28, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 28, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06056388
Lead sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Responsible party
Sponsor
First posted
Sep 28, 2023
Start date
Dec 31, 2023 (estimated)
Primary completion
Dec 31, 2024 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Sep 28, 2023

Study contacts

Xinbo Yu
Contact
xinboyu@proton.me
18019409340
Yiqun Wu
principal investigator · Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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