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

NCT07162389 | Active Not Recruiting DMC

• 1 other identifier: 1447/0062/UREC/UST.
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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?
• 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).
• 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.

Conditions

Alveolar Bone Atrophy

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  from Day0 , through week 4.

Study Arms (2)

Short Dental Implant Group.

EXPERIMENTAL

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)

Standard Dental Implant Group.

ACTIVE COMPARATOR

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

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

Short Dental Implant Group.; Standard Dental Implant Group.

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.

Short Dental Implant Group.; Standard Dental Implant Group.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \. 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.

You may not qualify if:

• \. Uncontrolled systemic diseases (e.g., diabetes with HbA1c \>7%, liver disease) or medications affecting bone healing (e.g., corticosteroids, bisphosphonates).
• \. 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).
• \. Active periodontal disease, parafunctional habits as bruxism, or prior bone grafting at the site.

Sponsors & Collaborators

• University of Science and Technology, Yemen: lead

Study Sites (1)

university of Sciences and Technology

Sanaa, 009671, Yemen

Location

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This clinical trial employs partial masking (blinding) to minimize bias in outcome assessments: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.Sc Candidate in Oral Surgery and implantology

Model Details: 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)

Study Record Dates

• First Submitted: July 18, 2025
• First Posted: September 9, 2025
• Study Start: August 1, 2025
• Primary Completion: February 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, 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.

Locations

YE (1)