ClinicalTrials.gg
Active, not recruitingNCT07162389Updated Sep 9, 2025

Comparative (Short vs. Standard) Length Implants in Early Stability Patterns.

An interventional study of Shallow-Threaded Short Implant (SHI) and Shallow-Threaded Standard Implant (SDI) in Alveolar Bone Atrophy, sponsored by University of Science and Technology, Yemen. Active, not recruiting at 1 site in Yemen. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-09.

Sponsored by University of Science and Technology, Yemen · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Primary completion was expected by Feb 2026, 9 months ago, but the record still lists the study as active, not recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Non-randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

Early Stability of Short vs. Standard Dental Implants in the Posterior Mandible

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.
Read the detailed description

A prospective, controlled, parallel-group pilot clinical trial comparing 7mm short implants (SHI) versus 11mm standard implants (SDI) with identical shallow-thread macrodesign (depth \<0.5mm) and 4.2mm diameter. Implant allocation is anatomically driven based on CBCT-measured vertical bone height (7mm group: 8.5-9mm residual bone; 11mm group: ≥12.5mm).

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.
02

Conditions studied

  • Alveolar Bone Atrophy

Browse trials for

Keywords

  • RFA
  • ISQ
  • Short dental implants
  • Shallow-threaded
  • Posterior Mandible
  • Early Dynamic Changes
  • primary Stability
  • Stability dip
03

In context

Alveolar Bone Loss

318 studies on the registry are indexed under Alveolar Bone Loss; 79 are open to participants now.

This study's planned enrollment of 10 is below the median of 25 across 269 interventional studies indexed under Alveolar Bone Loss.

Browse Alveolar Bone Loss studies →

Lead sponsor

University of Science and Technology, Yemen is the lead sponsor of 9 studies on the registry; 1 is open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

  • 1. Adults ≥18 years with partial posterior mandibular edentulism. 2. Bone height ≥7 mm and width >6 mm (CBCT-confirmed). 3. D2/D3 bone density (HU: 350-1250). 4. Healed posterior mandibular sites (3-6 months post-extraction). 5. Good oral hygiene (plaque index ≤1). 6. Willingness to adhere to study protocols.

Exclusion criteria

Exclusion Criteria:

  • 1. Uncontrolled systemic diseases (e.g., diabetes with >7%, liver disease) or medications affecting bone healing (e.g., , bisphosphonates).

    2. History of head/neck radiotherapy (with in past year). 3. Heavy smoking (>10 cigarettes/day). 4. Absolute 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.

Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    Short Dental Implant Group.

    Group A, Shallow-Threaded ,length 7mm, diameter 4.2mm,10 single dental implants.

    Device: Shallow-Threaded Short Implant (SHI) · Device: Shallow-Threaded Standard Implant (SDI)

  • Active comparator
    Standard Dental Implant Group.

    Group B, Shallow-Threaded ,length 11mm, diameter 4.2mm,10 single dental implants.

    Device: Shallow-Threaded Short Implant (SHI) · Device: Shallow-Threaded Standard Implant (SDI)

Interventions

  • DeviceShallow-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

  • DeviceShallow-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.

06

What researchers measure

Primary outcomes

  1. Implant Stability Quotient (ISQ) at Baseline (T0)

    Mean Resonance frequency Analysis(RFA) measurement taken immediately post-implantation(T0), to assess primary mechanical stability. ISQ range 1-100, low stability \<60, medium stability 60 to 69, high more than or equal 70. Reported as mean ISQ value per group.

    Time frame: Measurement at implant placement(Day 0)

  2. Insertion Torque value- ITV.

    The rotational torque in Ncm,applied during the final quarter-turn of implant insertion. This is direct measure of primary mechanical stability. Reported as mean ITV per group.

    Time frame: Measurement at during implant placement (intraoperative)

  3. Magnitude of Stability Dip

    The mean lowest point of stability curve , calculated as the greatest negative change in ISQ value from the baseline T0, measurement for each implant during the 4 -week monitoring period.

    Time frame: from implant placement (Day 0) through week4

  4. Time of Onset of Secondary Stability

    The mean time in days post implantation at which the ISQ value begins to consistently increase, indicating the start biological secondary stability. Defined as the time point after the nadir -T2or T3.where the ISQ value shows a positive increase confirmed at the subsequent measurement.

    Time frame: from Day0 , through week 4.

07

Study locations

1 site
  • university of Sciences and Technology
    Sanaa, 009671, Yemen
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Yes — Anonymized data available upon request after publication

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code

Time frame: 6 months from 21/07/2025

Access criteria: De-identified individual participant data will be made available upon reasonable request to corresponding author . Requests require a methodology sound proposal and a signed data access agreement.

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

Started Aug 2025 (actual). Primary completion is estimated for Feb 2026, 6 months after the start.

Of 167 non-industry interventional studies with no phase under Alveolar Bone Loss, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 30. This study's planned 6 months is below that.

Counting every sponsor, half of 167 studies reached it within 18 months; a quarter within 11 and three quarters within 30.

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

Registered
Jul 18, 2025
First posted
Sep 9, 2025
StartActual
Aug 1, 2025
Primary completionEst.
Feb 1, 2026
CompletionEst.
Dec 1, 2026
Last update
Sep 9, 2025
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 9, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07162389
Lead sponsor
University of Science and Technology, Yemen
Responsible party
Mohammad A Al-Jonaid M.Sc. (M.Sc Candidate in Oral Surgery and implantology, University of Science and Technology, Yemen) — Principal investigator
First posted
Sep 9, 2025
Start date
Aug 1, 2025
Primary completion
Feb 1, 2026 (estimated)
Completion
Dec 1, 2026 (estimated)
Last update
Sep 9, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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