Alveolar Bone AtrophyNCT07162389
Comparative (Short vs. Standard) Length Implants in Early Stability Patterns.
A study testing Shallow-Threaded Short Implant (SHI) and Shallow-Threaded Standard Implant (SDI) in people with Alveolar Bone Atrophy, run by University of Science and Technology, Yemen at 1 site in Yemen.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Alveolar Bone Atrophy
- What is being tested?
- Shallow-Threaded Short Implant (SHI) and Shallow-Threaded Standard Implant (SDI)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteYemen
- Study dates
- 1 Aug 2025to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 1. Uncontrolled systemic diseases (e.g., diabetes with HbA1c >7%, liver disease) or medications affecting bone healing (e.g., corticosteroids, bisphosphonates).
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Stability of Short Dental Implants With Shallow Threads in the Posterior Mandible: A Controlled Clinical Pilot Study .
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.
Read more
- 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?
- Screening: A dental exam and 3D scan to check bone quality.
- Implant Placement:
- Short (7mm) or standard (11mm) implant, depending on your bone height.
- Minimally invasive surgery with local anesthesia.
- 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
- 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).
- 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.
- 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:
- Primary stability (mechanical) transitions to secondary stability (biological).
- 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:
- Shallow threads + short length in posterior mandible.
- Weekly RFA tracking during the dip phase.
- HU-quantified bone density correlation with ISQ trends.
- Conditions
- Alveolar Bone Atrophy
- Being tested
- Shallow-Threaded Short Implant (SHI), Shallow-Threaded Standard Implant (SDI)
- Keywords
- RFA, ISQ, Short dental implants, Shallow-threaded, Posterior Mandible, Early Dynamic Changes, primary Stability, Stability dip
- Medical subject headings
- Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shallow-Threaded Short Implant (SHI)Device
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)Device
A 11mm long, 4.2mm diameter dental implant with shallow thread (<0.5mm depth) macrodesign, surgically placed in the jawbone to restore missing teeth.
| Study group | Role | What they receive |
|---|---|---|
| Short Dental Implant Group. | Experimental | Group A, Shallow-Threaded ,length 7mm, diameter 4.2mm,10 single dental implants. Receives: Device: Shallow-Threaded Short Implant (SHI); Device: Shallow-Threaded Standard Implant (SDI) |
| Standard Dental Implant Group. | Active comparator | Group B, Shallow-Threaded ,length 11mm, diameter 4.2mm,10 single dental implants. Receives: Device: Shallow-Threaded Short Implant (SHI); Device: Shallow-Threaded Standard Implant (SDI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Measurement at implant placement(Day 0)
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.
Measured: Measurement at during implant placement (intraoperative)
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.
Measured: from implant placement (Day 0) through week4
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.
Measured: from Day0 , through week 4.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start1 Aug 2025
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Bone AtrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Interventional Study A Prospective, controlled, parallel-group, anatomically allocated pilot study . 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)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Science and Technology, Yemen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad A Al-Jonaid M.Sc., University of Science and Technology, Yemen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07162389
- Sponsor's protocol ID
- 1447/0062/UREC/UST.
- Status last verified
- Sep 2025
- First submitted
- 18 Jul 2025
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized data available upon request after publication
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Stability of Short Dental Implants With Shallow Threads in the Posterior Mandible: A Controlled Clinical Pilot Study .
- ClinicalTrials.gov ID
- NCT07162389
- Acronym / sponsor ID
- 1447/0062/UREC/UST.
- Conditions
- Alveolar Bone Atrophy
- Keywords
- RFA, ISQ, Short dental implants, Shallow-threaded, Posterior Mandible, Early Dynamic Changes, primary Stability, Stability dip
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of Science and Technology, YemenUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 9 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
- Screening: A dental exam and 3D scan to check bone quality.
- Implant Placement:
- Short (7mm) or standard (11mm) implant, depending on your bone height.
- Minimally invasive surgery with local anesthesia.
- 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.
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
- 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).
- 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.
- 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:
- Primary stability (mechanical) transitions to secondary stability (biological).
- 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:
- Shallow threads + short length in posterior mandible.
- Weekly RFA tracking during the dip phase.
- HU-quantified bone density correlation with ISQ trends.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Interventional Study A Prospective, controlled, parallel-group, anatomically allocated pilot study . 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)
| Arm | Type | Receives |
|---|---|---|
| Short Dental Implant Group. | Experimental | Device: Shallow-Threaded Short Implant (SHI), Device: Shallow-Threaded Standard Implant (SDI)Group A, Shallow-Threaded ,length 7mm, diameter 4.2mm,10 single dental implants. |
| Standard Dental Implant Group. | Active comparator | Device: Shallow-Threaded Short Implant (SHI), Device: Shallow-Threaded Standard Implant (SDI)Group B, Shallow-Threaded ,length 11mm, diameter 4.2mm,10 single dental implants. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 1. Uncontrolled systemic diseases (e.g., diabetes with HbA1c >7%, liver disease) or medications affecting bone healing (e.g., corticosteroids, bisphosphonates).
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Device | Short Dental Implant Group., Standard Dental Implant Group. |
| 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. | Device | Short Dental Implant Group., Standard Dental Implant Group. |
Primary outcome
Implant Stability Quotient (ISQ) at Baseline (T0)
Time frame: Measurement at implant placement(Day 0)
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.
Insertion Torque value- ITV.
Time frame: Measurement at during implant placement (intraoperative)
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.
Magnitude of Stability Dip
Time frame: from implant placement (Day 0) through week4
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 of Onset of Secondary Stability
Time frame: from Day0 , through week 4.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Individual participant dataSharing planned: Yes. Anonymized data available upon request after publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shallow-Threaded Short Implant (SHI) and Shallow-Threaded Standard Implant (SDI) in people with Alveolar Bone Atrophy, run by University of Science and Technology, Yemen at 1 site in Yemen.
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 1 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Yemen. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant Stability Quotient (ISQ) at Baseline (T0) (time frame: Measurement at implant placement(Day 0)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Sep 2025.