AzTrials
AzTrials

Tooth LossNCT06056388

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

A study testing Straumann BLX implant and Straumann BLT implant in people with Tooth Loss and Partial-edentulism, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Tooth Loss, Partial-edentulism
What is being tested?
Straumann BLX implant and Straumann BLT implant
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
No sites listed yet
Study dates
31 Dec 2023to 31 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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)].

Who cannot join

  • 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

Trial locations and contacts

No sites are listed yet.

Xinbo Yu contact

18019409340

xinboyu@proton.me

About this study

Official title: 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.

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.

Being tested
Straumann BLX implant, Straumann BLT implant
Keywords
Computer-Assisted Surgery, Dental Implants
Medical subject headings
Tooth Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Straumann BLX implantDevice

    Implant system with a deep fixture thread depth.

  • Straumann BLT implantDevice

    Implant system with a regular fixture thread depth.

Study groups in NCT06056388
Study groupRoleWhat they receive
Deep-threaded implantsActive comparatorStraumann BLX implants
Receives: Device: Straumann BLX implant
Regular-threaded implantsPlacebo comparatorStraumann BLT implants
Receives: Device: Straumann BLT implant

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Sufficiently described in the Title

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: Postoperative (Day 1-5)

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

    Sufficiently described in the Title

    Measured: Postoperative (Day 1-5)

Secondary outcomes (7)

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

    Sufficiently described in the Title

    Measured: Intraoperative (Day 0)

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

    Sufficiently described in the Title

    Measured: Intraoperative (Day 0)

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

    Sufficiently described in the Title

    Measured: Postoperative (Day 1-5)

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

    Sufficiently described in the Title

    Measured: Postoperative (1 year)

  5. Rate of implant survival measured in percentage

    Sufficiently described in the Title

    Measured: Postoperative (4 months & 1 year)

  6. Number of participants with biological or technical complications

    Sufficiently described in the Title

    Measured: 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

    Measured: Postoperative (4 months & 1 year)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2023
  2. Study start31 Dec 2023 (estimated)
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06056388
Sponsor's protocol ID
SDC-23-1
Status last verified
Aug 2023
First submitted
3 Sep 2023
Last updated
28 Sep 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

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

Questions about this trial

What is this clinical trial studying?

A study testing Straumann BLX implant and Straumann BLT implant in people with Tooth Loss and Partial-edentulism, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Xinbo Yu (18019409340, xinboyu@proton.me), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Placement accuracy measured as global platform deviation in millimeters and assessed by DCarer or coDiagnostiX (time frame: Postoperative (Day 1-5)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06056388, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in