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Trial registered on ANZCTR


Registration number
ACTRN12624001454561
Ethics application status
Approved
Date submitted
29/09/2024
Date registered
16/12/2024
Date last updated
16/12/2024
Date data sharing statement initially provided
16/12/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The efficiency of stackable surgical guide in immediate dental implant placement and loading
Scientific title
valuation of the efficiency of dental implant placement with immediate loading using stackable surgical guide in Edentulous patients or with teeth indicated for extraction
Secondary ID [1] 312530 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Edentulous 334403 0
teeth extraction 335170 0
Condition category
Condition code
Oral and Gastrointestinal 331041 331041 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention name: Dental implant placement with immediate loading using stackable surgical guide.

Placing four dental implants according to the All-on-Four concept on edentulous patients or patients with teeth indicated for extraction using a stackable surgical guide. This involves immediate placement of a full-arch restoration fixed onto four implants in the mandible on the same day. The process includes the following details:

1. Preoperative Data Collection (Duration: Approximately 75 minutes)

1.1 Patient consultation and clinical examination.
1.2 Obtain digital maxillary and mandibular primary impressions and accurate bite registration.
1.3 Obtain skull cone beam computed tomography (CBCT) with the patient wearing the bite registration.
1.4 Facial scan: Perform a 3D facial scan using photogrammetry. This scan captures the patient's facial anatomy, including soft tissue contours, essential for ensuring optimal aesthetic outcomes.
2. Digital Implant Planning

2.1 Merging Data Sets: Merge the CBCT scan, intraoral scan, and facial scan in specialized implant planning software (r2gate). This integrated model provides a 3D representation of the patient’s facial soft tissue, dentition, and underlying bone structures.
2.2 Implant Positioning: Determine the ideal implant positions (angulation, depth, and distance between implants) to ensure proper support for the immediate loading prosthesis.
3. Design of Stackable Surgical Guide

3.1 Guide Design: Design a stackable surgical guide in the planning software. The guide includes multiple stackable layers for different surgical steps:
Base Guide: Fits onto the patient's arch or edentulous ridge, providing stability, and may be used as a guide for bone reduction if needed.
Base Carrier: Seated on the remaining teeth or bone, providing stability and acting as a support platform for the base guide.
Implant Placement Guide: Guides the surgical drill for precise osteotomy at the planned implant sites, ensuring correct positioning and angulation during implant insertion.
Abutment Guide: After implant placement, this guide helps position the abutments precisely on the implant heads to ensure proper orientation for the final restoration.
Provisional Restoration Guide: Ensures accurate placement of the provisional restoration, accounting for abutment position, occlusion, and esthetics.
3.2 3D Printing of the Surgical Guide: Export the guide design as an STL file and send it to a 3D printer. The guide is printed using biocompatible materials that are sterilizable for surgical use.
4. Surgical Procedure (Duration: Approximately 90 minutes)
The intervention will be provided by Oral and maxillofacial surgery PhD resident with 5 years experience in dental surgery,
4.1 Pre-Surgical Preparations:
Administer local anesthesia and prepare the surgical site. Verify the fit of the base surgical guide in the patient’s mouth to ensure stability and accurate positioning.
4.2 Guide Placement:
Secure the base layer of the stackable guide onto the patient's arch or edentulous ridge. The guide should fit passively without any pressure points. Sequentially place the other layers of the guide as needed for each surgical step.
4.3 Osteotomy (Drilling):
Using the drilling guide layer, perform osteotomies at the predetermined implant sites. The guide ensures precise angulation and depth control during drilling.
4.4 Implant Placement:
Once the osteotomies are completed, switch to the implant placement guide layer. Insert the implants through the guide, ensuring precise placement in terms of depth and angulation. Measure and record the insertion torque to assess primary stability, which is critical for immediate loading.
5. Immediate Loading and Prosthesis Placement

5.1 Immediate Loading Prosthesis:
After implant placement, place the prefabricated immediate loading prosthesis. This provisional prosthesis is digitally designed and created before surgery based on the virtual implant plan. Attach the prosthesis to the implants with a temporary fixation method, depending on stability.
5.2 Occlusal Adjustments:
Perform occlusal adjustments to ensure proper bite alignment and distribute functional forces evenly across the implants. Verify the esthetic outcome by evaluating the prosthesis in relation to the patient’s facial scan (e.g., lip support, smile line).
6. Postoperative Care

Postoperative Medications Provided:
Antibiotics (e.g., amoxicillin or clindamycin, based on the patient's medical profile), pain relievers (e.g., ibuprofen or paracetamol), and an antimicrobial mouth rinse (e.g., chlorhexidine) are provided to reduce infection risk and manage discomfort.
Care Instructions Delivery:
Patients receive postoperative care instructions in a printed handout detailing dietary guidelines, oral hygiene protocols, and tips for minimizing discomfort.
Adherence Monitoring:
Patient adherence to postoperative care protocols will be monitored through weekly follow-up visits in the first month and then one visit each month. Adherence questionnaire also will be used.
Intervention code [1] 329078 0
Treatment: Surgery
Intervention code [2] 329859 0
Treatment: Devices
Comparator / control treatment
Control name: Dental implant placement with immediate loading using single layer surgical guide.
Placing four dental implants according to All-on-Four concept on edentulous patients or with teeth indicated for extraction using one layer surgical guide.
This involves immediate placing of full arch restoration fixed onto four implants in mandible at the same day.
The process will consist of the following steps:
1. Preoperative data collection (Duration: Approximately 45 minutes)
Preoperative will include clinical examinations, panoramic radiographs, and CBCT imaging.

2. Design of The single-layer surgical guide:
The single-layer surgical guide will be designed based on CBCT to guide initial drilling and implant positioning. However, no stackable guide components or additional layers will be used in this group. This guide will primarily assist with the depth, angulation, and placement of implants but will not incorporate advanced digital facial scanning or multi-step guides.

2. Surgical Procedure (Duration: Approximately 60 minutes)
The surgical procedure for the comparison group will be as follows:
Non-Stackable, Single-Layer Guide: A non-stackable surgical guide will be fabricated based on the preoperative CBCT scan. This guide will provide basic assistance for drill positioning (depth, angle, and orientation).

Implant Placement: Using the single-layer guide, implants will be placed according to the planned positions. Following implant insertion, primary stability will be assessed through insertion torque and resonance frequency analysis (RFA). Implants with sufficient primary stability (e.g., The implant stability quotient ISQ = 60) will undergo immediate loading.

Immediate Loading: Implants with adequate primary stability will be restored with a provisional prosthesis immediately after surgery. The provisional restoration will be adjusted to avoid excessive occlusal forces and ensure optimal conditions for osseointegration.

Postoperative Care
Provide the patient with postoperative care instructions, including diet restrictions, oral hygiene protocols, and medications.
Control group
Active

Outcomes
Primary outcome [1] 338856 0
Implant Success
Timepoint [1] 338856 0
T0: Baseline assessment of implant placement and initial loading.
T1 (4 months post operative, primary time point): Early signs of success or failure (e.g., infection, mobility).
T2 (12 months post operative): Final assessment of success at 1 year.
Primary outcome [2] 338857 0
Accuracy of Implant Placemaent: Deviation from Planned Position
Timepoint [2] 338857 0
T0: Immediate post-op CBCT to assess the accuracy of implant placement (deviation from planned position).
T1 (12 months post operative): Optional follow-up imaging to check for any later-stage positional changes.
Primary outcome [3] 339389 0
Primary Stability: Insertion Torque
Timepoint [3] 339389 0
T0: Measure insertion torque during implant placement.
Secondary outcome [1] 437696 0
Marginal Bone Loss
Timepoint [1] 437696 0
T0: Baseline radiographs to measure initial bone level.
T1 (4 months post operative): Assess early bone remodeling and marginal bone loss.
T2 (12 months post operative): Final assessment of bone loss after 1 year.
Secondary outcome [2] 439733 0
Peri-Implant Mucositis: bleeding
Timepoint [2] 439733 0
T0: Baseline gingival and mucosal health.
T1 (1 week post operative): Check for bleeding on probing.
T2 (1 month post operative): Check for bleeding on probing. .
T3 (4 months post operative): Check for bleeding on probing.
T4 (12 months post operative): Check for bleeding on probing.
Secondary outcome [3] 439734 0
Pain and Discomfort
Timepoint [3] 439734 0
T0: Pre-op and immediate post-op pain/discomfort (VAS).
T1 (1 week post operative): pain/discomfort (VAS).
T2 (1 month post operative): pain/discomfort (VAS).
Secondary outcome [4] 441570 0
Survival Rates (primary outcome)
Timepoint [4] 441570 0
T0: Baseline assessment of implant placement and initial loading.
T1: (12 months post operative): Final assessment of survival at 1 year.
Secondary outcome [5] 441571 0
Fit of Surgical Guide
Timepoint [5] 441571 0
T0: Immediate during operative.
Secondary outcome [6] 441572 0
Stability: Implant Stability Quotient (ISQ)
Timepoint [6] 441572 0
T0: Measure ISQ immediately after placement.
T1 (1 week post operative): Measure ISQ value 1 week post-op.
T3 (3 months post operative, primary timepoint): Repeat ISQ measurement to assess stability after early healing.
T5 (12 months): Final ISQ to assess long-term stability.
Secondary outcome [7] 441575 0
Aesthetic Satisfaction
Timepoint [7] 441575 0
T0: Pre-op and immediate post-op pain/discomfort (VAS).
T1 (1 week): Pain, discomfort, and post-op healing.
T2 (1 month post operative): Patient satisfaction with esthetics.
T3 (4 months post operative): Patient satisfaction with esthetics.
T4 (12 months): Final assessment of patient satisfaction with esthetics
Secondary outcome [8] 441576 0
Quality of Life
Timepoint [8] 441576 0
T0: Pre-op quality of life assessment using OHIP
T2 (1 month post operative): quality of life assessment using OHIP
T3 (4 months post operative): quality of life assessment using OHIP
T4 (12 months): Final assessment of quality of life assessment using OHIP
Secondary outcome [9] 441578 0
Peri-Implant Mucositis: probing depth
Timepoint [9] 441578 0
T1 (1 month post operative): Evaluate probing depth.
T3 (4 months post operative): Evaluate probing depth.
T4 (12 months post operative): Evaluate probing depth.
Secondary outcome [10] 441587 0
Keratinized Tissue Width
Timepoint [10] 441587 0
T1 (1 week post operative): Measure the width of keratinized gingiva.
T2 (1 month post operative): Measure the width of keratinized gingiva.
T3 (4 months post operative): Measure the width of keratinized gingiva.
T4 (12 months post operative): Measure the width of keratinized gingiva.

Eligibility
Key inclusion criteria
1. Edentulous patients or with teeth indicated for extraction.
2. Have adequate, good quality bone in the mandible
3. sufficient width of attached gingiva around implant (2 mm minimum)
4. All implants can be seated with a torque > 35Ncm and have initial primary stability and ISQ 65 and above.
Minimum age
40 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. parafunctional habits
2. systemic diseases affect the implant osteointegration.
3. local contraindication for implant.
4. History of previous chemotherapy or radiological therapy.
5. Treated with drugs that affect bone modeling

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Computer generated randomization
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using a randomization table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/01/2025
Actual
Date of last participant enrolment
Anticipated
15/01/2025
Actual
Date of last data collection
Anticipated
15/02/2026
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 26563 0
Syrian Arab Republic
State/province [1] 26563 0

Funding & Sponsors
Funding source category [1] 316954 0
University
Name [1] 316954 0
Damascus university
Country [1] 316954 0
Syrian Arab Republic
Primary sponsor type
University
Name
Damascus university
Address
Country
Syrian Arab Republic
Secondary sponsor category [1] 320116 0
None
Name [1] 320116 0
none
Address [1] 320116 0
Country [1] 320116 0
Syrian Arab Republic

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315710 0
The Biomedical Research Ethics Committee (BMREC)
Ethics committee address [1] 315710 0
Ethics committee country [1] 315710 0
Syrian Arab Republic
Date submitted for ethics approval [1] 315710 0
24/06/2024
Approval date [1] 315710 0
14/07/2024
Ethics approval number [1] 315710 0
DN-140724-270

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 135562 0
Dr Youssef Alrmeela
Address 135562 0
Faculty of Dental Medicine, Damascus University, Al-Mazzeh St. Damascus, PO Box 30621
Country 135562 0
Syrian Arab Republic
Phone 135562 0
+963930350948
Fax 135562 0
Email 135562 0
alrmeelaym@gmail.com
Contact person for public queries
Name 135563 0
Aladdin Alshawa
Address 135563 0
Faculty of Dental Medicine, Damascus University, Al-Mazzeh St. Damascus, PO Box 30621
Country 135563 0
Syrian Arab Republic
Phone 135563 0
+963934587086
Fax 135563 0
Email 135563 0
Aladdin.sh.1993@gmail.com
Contact person for scientific queries
Name 135564 0
Aladdin Alshawa
Address 135564 0
Faculty of Dental Medicine, Damascus University, Al-Mazzeh St. Damascus, PO Box 30621
Country 135564 0
Syrian Arab Republic
Phone 135564 0
+963934587086
Fax 135564 0
Email 135564 0
Aladdin.sh.1993@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.