Comparative (Short vs. Standard) Length Implants in Early Stability Patterns.
NCT ID: NCT07162389
Last Updated: 2025-09-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
10 participants
INTERVENTIONAL
2025-08-01
2026-12-01
Brief Summary
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This study compares how well short dental implants (7mm) work compared to standard-length implants (11mm) when placed in the back part of the lower jaw. Both types of implants have special shallow threads designed to reduce stress on the bone. The main goal is to see how stable they are during the first 4 weeks after placement-a critical time for healing.
* Short implants may be a good option for patients with limited jawbone height, avoiding the need for bone grafting.
* Understanding their early stability helps dentists decide when it's safe to place teeth on them.
* This study uses advanced tools like 3D scans (CBCT) and implant stability measurements (ISQ) to track healing.
What will happen in the study?
1. Screening: A dental exam and 3D scan to check bone quality.
2. Implant Placement:
* Short (7mm) or standard (11mm) implant, depending on your bone height.
* Minimally invasive surgery with local anesthesia.
3. Follow-ups: Painless stability checks at end of 1, 2, 3, and 4 weeks using a small device (RFA).
Who can participate?
Adults (18-60 years) missing posterior teeth in the lower jaw, with:
* Enough bone width (≥6.5mm).
* No uncontrolled health conditions (e.g., severe diabetes).
* Non-smokers or light smokers (\<10 cigarettes/day).
* Benefits: Free implant placement and monitoring; contributes to better dental care.
* Risks: Typical surgery risks (swelling, infection); rare nerve injury (\<5% chance).
How long is the study?
* Active participation: 4 weeks (with optional long-term follow-up).
* Total study duration: \~12 months (including data analysis). Mohammad Abdulwahab Al-Jonaid University of Science and Technology, Sana'a.
* Supervisor: Dr. Ali Al-Hudaied, Oral and Maxillofacial Surgery Specialist.
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Detailed Description
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Technical Innovations
1. Thread Geometry: Dual shallow-thread reverse-buttress design (0.2-0.5mm depth) with progressive pitch to optimize cortical engagement while minimizing shear stress (Ao et al. 2010).
2. Surgical Protocol: Standardized osteotomy using under-drilling for D2 bone (final drill diameter reduced by 0.2mm) and non-condensing drilling for D3 bone to prevent over-compression.
3. Stability Metrics:
* Primary Stability: ITV (last quarter-turn torque) + ISQ (Penguin RFA, mean of 4-directional measurements).
* Dynamic Stability: ISQ tracked at T0 (baseline), T1 (7d), T2 (14d), T3 (21d), T4 (28d) to capture dip magnitude (ΔISQ) and recovery onset (start of biological stability).
Bone Density Integration
* Pre-op CBCT: Hounsfield Unit (HU) stratification (D2: 800-1250 HU; D3: 350-850 HU) with 2mm² ROI analysis at coronal/middle/apical levels.
* Intra-op Validation: Tactile assessment using Lekholm \& Zarb scale (D2: "white pine" resistance; D3: "balsa wood").
Quality Controls
* Operator Standardization: Single experienced surgeon performs all placements.
* RFA Calibration: Pre-measurement checks with reference block and standardized SmartPeg torque (5-10 Ncm).
* Blinding: ISQ measurements by research assistant masked to implant type.
Rationale for 4-Week Endpoint
Focuses on the critical early healing phase where:
1. Primary stability (mechanical) transitions to secondary stability (biological).
2. The "stability dip" (week 2-4) predicts osseointegration failure risk.
Technical Constraints
* Limited Sample Size (n=20): Pilot study design prioritizes feasibility over powered comparisons.
* Bone Density Homogeneity: Excludes D1/D4 bone to reduce confounding.
Innovative Aspects
First clinical study to combine:
1. Shallow threads + short length in posterior mandible.
2. Weekly RFA tracking during the dip phase.
3. HU-quantified bone density correlation with ISQ trends.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
. Anatomically-Driven Allocation
* Group A (Short Implants): 7mm implants placed in sites with 8.5-9mm residual bone height (measured from crest to inferior alveolar nerve + 1.5mm safety margin).
* Group B (Standard Implants): 11mm implants placed in sites with ≥12.5mm bone height.
* Rationale: Mimics real-world clinical decision-making where implant length is determined by available bone anatomy.
2\. Technical Controls:
* Standardized diameter: All implants 4.2mm (Tiologic Twinfit system).
* Identical surface/macrodesign: SLA surface, shallow threads (\<0.5mm depth), reverse-buttress profile.
* Surgical calibration: Single operator, under-drilling protocol for D2 bone (final drill -0.2mm), non-condensing drilling for D3 bone.
3\. Dynamic Monitoring Protocol:
* Timepoints: T0 immediate, T1,T2,T3,T4 (at the end of weeks- 1,2,3,4)
HEALTH_SERVICES_RESEARCH
SINGLE
1. Blinded Parties
* Outcome Assessors:
* The researcher performing resonance frequency analysis (RFA) measurements (ISQ values at T0-T4) is masked to:
* Implant length (7mm vs. 11mm)
* Insertion torque value (ITV) Rationale: Prevents measurement bias in stability tracking.
* Data Analysts:
* Statisticians processing ISQ trends are blinded to group allocation until analysis completion.
2. Non-Blinded Parties
* Surgeon: Cannot be masked due to visual/tactile differences during osteotomy preparation.
* Patients: Aware of implant type due to post-operative healing abutment visibility.
3. Blinding Methods
* RFA Protocol:
* SmartPeg placement/readings performed by a separate researcher not involved in surgery.
* ISQ values recorded using coded forms without implant length details.
Study Groups
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Short Dental Implant Group.
Group A, Shallow-Threaded ,length 7mm, diameter 4.2mm,10 single dental implants.
Shallow-Threaded Short Implant (SHI)
A 7mm long, 4.2mm diameter dental implant with shallow thread (\<0.5mm depth) Macrodesign, surgically placed in the jawbone to restore missing teeth
Shallow-Threaded Standard Implant (SDI)
A 11mm long, 4.2mm diameter dental implant with shallow thread (\<0.5mm depth) macrodesign, surgically placed in the jawbone to restore missing teeth.
Standard Dental Implant Group.
Group B, Shallow-Threaded ,length 11mm, diameter 4.2mm,10 single dental implants.
Shallow-Threaded Short Implant (SHI)
A 7mm long, 4.2mm diameter dental implant with shallow thread (\<0.5mm depth) Macrodesign, surgically placed in the jawbone to restore missing teeth
Shallow-Threaded Standard Implant (SDI)
A 11mm long, 4.2mm diameter dental implant with shallow thread (\<0.5mm depth) macrodesign, surgically placed in the jawbone to restore missing teeth.
Interventions
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Shallow-Threaded Short Implant (SHI)
A 7mm long, 4.2mm diameter dental implant with shallow thread (\<0.5mm depth) Macrodesign, surgically placed in the jawbone to restore missing teeth
Shallow-Threaded Standard Implant (SDI)
A 11mm long, 4.2mm diameter dental implant with shallow thread (\<0.5mm depth) macrodesign, surgically placed in the jawbone to restore missing teeth.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2\. History of head/neck radiotherapy (with in past year). 3. Heavy smoking (\>10 cigarettes/day). 4. Absolute contraindications for oral surgery (e.g., recent MI/CVA \< 6months, bleeding disorders).
5\. Active periodontal disease, parafunctional habits as bruxism, or prior bone grafting at the site.
18 Years
60 Years
ALL
Yes
Sponsors
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University of Science and Technology, Yemen
OTHER
Responsible Party
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Mohammad A Al-Jonaid M.Sc.
M.Sc Candidate in Oral Surgery and implantology
Locations
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university of Sciences and Technology
Sanaa, , Yemen
Countries
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Provided Documents
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Document Type: Study Protocol and Informed Consent Form
Other Identifiers
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1447/0062/UREC/UST.
Identifier Type: -
Identifier Source: org_study_id
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