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A clinical study comparing two types of dental implant abutments used in fixed screw-retained prostheses

Clinical evaluation of multiunit abutments versus prefabricated abutments in screw-retained implant-supported prostheses

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN15469945
Enrollment
20
Registered
2025-10-15
Start date
2024-05-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Partial edentulism (missing posterior teeth) requiring implant-supported fixed prosthetic rehabilitation. Oral Health

Interventions

Intervention 1 – Multiunit abutment group (test group): Participants receive dental implants restored with multiunit abutments supporting screw-retained fixed prostheses. • Implant system: MEGAGEN “An

Sponsors

Damascus University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Good general health. 2. Presence of partial edentulism (missing one or more posterior teeth) requiring fixed, screw-retained, implant-supported prosthetic rehabilitation. 3. Adequate bone volume and bone quality type D2–D3, confirmed radiographically (CBCT). 4. Sufficient vertical bone height at the planned implant site to allow placement of standard-length implants without additional grafting. 5. Patients with healthy oral soft tissues and no active periodontal or mucosal infections. 6. Adequate inter-arch space and occlusal relationship to permit restoration with a screw-retained prosthesis. 7. Non-smokers or light smokers (<10 cigarettes/day). 8. Patients motivated to maintain oral hygiene and to attend all scheduled follow-up visits for at least 12 months. 9. Patients who have provided written informed consent to participate in the study after receiving full explanation of procedures and risks.

Exclusion criteria

Exclusion criteria: 1. Systemic contraindications to oral surgery or implant placement (e.g., uncontrolled diabetes, hypertension, bleeding disorders, immunocompromised conditions). 2. History of bisphosphonate therapy or other antiresorptive or antiangiogenic medications affecting bone metabolism. 3. Smoking habit exceeding 10 cigarettes per day or use of smokeless tobacco. 4. Alcohol or drug abuse. 5. Pregnancy or lactation at the time of enrolment. 6. Untreated or active periodontal disease, mucosal lesions, or infection at the intended implant site. 7. Poor bone quality or quantity (types D1 or D4, insufficient vertical or buccolingual bone volume) precluding stable implant placement without grafting. 8. Previous bone augmentation or implant failure in the same site. 9. Parafunctional habits such as bruxism or clenching. 10. Malocclusion or unstable occlusal relationship preventing proper alignment of screw-retained restorations. 11. Patients on long-term corticosteroid therapy or radiotherapy to the head and neck region. 12. Allergy or hypersensitivity to titanium or any dental materials used in the study

Design outcomes

Primary

MeasureTime frame
Accuracy of prosthetic adaptation (Passive fit) between implant and abutment components. The passive fit of the screw-retained prosthesis on the implant-abutment complex will be evaluated using three validated methods applied sequentially: 1.Screw resistance (Ratchet torque) test (clinical method): Gradual torque application (0–35 N·cm) using a manual torque wrench to detect any sudden increase in torque resistance or movement, indicating tension or misfit. Smooth, resistance-free tightening (Passive fit) denotes successful adaptation. 2.One-screw test (visual and tactile verification): After securing one abutment screw, the seating of the opposing abutment is inspected visually and with an explorer for marginal gaps or vertical displacement. A stable, gap-free seating indicates passive fit. 3.Screw deformation analysis (mechanical evaluation): The abutment screw used during the initial prosthesis fixation will be replaced with a new screw at follow-up. The removed screw will be cleaned ultrasonically and examined under an optical microscope to detect mechanical deformation, including: oThread flattening or wear oMicrocracks along threads oBending or surface irregularities The presence of any deformation indicates internal stress due to misfit. Timing of assessment: •At prosthesis delivery (baseline) •At follow-up (1 week post-loading) Outcome classification: Fit quality categorized as: •Complete passive fit (no tension, no deformation) •Partial fit with mild strain •Non-passive fit / detectable misfit or screw deformation

Secondary

MeasureTime frame
There are no secondary outcome measures

Countries

Syria

Contacts

Public ContactJihad ;Zafin Abou Nassar ;kara beit

;

Jihad.AbouNassar@gmail.com;Zafin.beit@gmail.com+963 967350869;+963 944594323

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026