A clinical study comparing two types of dental implant abutments used in fixed screw-retained prostheses
| ISRCTN | ISRCTN15469945 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15469945 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | UDDS-3062-01042024/SRC-1550 |
| Sponsor | Damascus University |
| Funder | Damascus University |
- Submission date
- 14/10/2025
- Registration date
- 15/10/2025
- Last edited
- 15/10/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
This study is exploring two different methods for fitting dental implants in people who need fixed replacement teeth. Both methods use the same type of implant, but differ in how the replacement teeth are attached. The goal is to find out which method offers better results in terms of comfort, durability, and long-term success.
Who can participate?
The study is open to adults who are in generally good health and missing one or more back teeth, and who need fixed, screw-retained dental implants. To take part, individuals must have enough healthy bone in the jaw to support the implants without needing extra bone grafting. They should also have healthy gums and no active infections in the mouth. The space between the upper and lower teeth must be suitable for the type of replacement being used. People who smoke heavily are not eligible, but non-smokers or light smokers (fewer than 10 cigarettes a day) may be considered. Participants must be motivated to keep their mouth clean and attend all follow-up visits for at least a year. Everyone must give written consent after the study has been fully explained.
What does the study involve?
Participants will be randomly placed into one of two groups. One group will receive implants with a special connector called a “multiunit abutment,” while the other group will receive implants with a standard prefabricated connector. Both groups will get fixed replacement teeth that are screwed into place. The procedure and follow-up care will be the same for everyone, and all parts will be fitted according to the manufacturer’s instructions.
What are the possible benefits and risks of participating?
Taking part may help improve dental treatment options in the future. Participants will receive high-quality dental care as part of the study. As with any dental procedure, there may be risks such as discomfort, infection, or complications with the implant, but these will be carefully managed by the clinical team.
Where is the study run from?
Department of Prosthodontics, Damascus University (Syria)
When is the study starting and how long is it expected to run for?
April 2024 to December 2024
Who is funding the study?
Department of Prosthodontics, Damascus University (Syria)
Who is the main contact?
hasan.alzoubi@damascusuniversity.edu.sy
Contact information
Scientific, Principal investigator
Mazzeh
Damascus
-
Syria
 ORCID ID |
0009-0006-1429-5753 |
|---|---|
| Phone | +963 941322494 |
| hasan.aljasem@damscusuniversity.edu.sy |
Public, Scientific
Mazzeh
Damascus
-
Syria
| Phone | +963 967350869 |
|---|---|
| Jihad.AbouNassar@gmail.com |
Public, Scientific
Mazzeh
Damascus
-
Syria
| Phone | +963 944594323 |
|---|---|
| Zafin.beit@gmail.com |
Public, Scientific
Mazzeh
Damascus
-
Syria
| ORCID ID |
0000-0001-7759-7720 |
|---|---|
| Phone | +963 943647659 |
| hasan.alzoubi@damascusuniversity.edu.sy |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-center interventional randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Clinical evaluation of multiunit abutments versus prefabricated abutments in screw-retained implant-supported prostheses |
| Study acronym | MuPFA Study |
| Study objectives | To clinically evaluate and compare the performance of multiunit abutments and prefabricated abutments used in screw-retained implant-supported prostheses, in terms of prosthetic adaptation (passive fit) between the abutment and the implant |
| Ethics approval(s) |
Approved 01/04/2024, Biomedical Research Ethics Committee of Damascus University (University Presidency Building, University Campus, Baramkeh 23J89, Damascus, -, Syria; +963 1133923012; president@damasuniv.edu.sy), ref: 3062 |
| Health condition(s) or problem(s) studied | Partial edentulism (missing posterior teeth) requiring implant-supported fixed prosthetic rehabilitation. |
| Intervention | Intervention 1 – Multiunit abutment group (test group): Participants receive dental implants restored with multiunit abutments supporting screw-retained fixed prostheses. • Implant system: MEGAGEN “Anyone” implants. • Prosthetic workflow: conventional impression, fabricated screw-retained prosthesis fixed on multiunit abutments. • Abutment and prosthesis screws torqued according to manufacturer’s specifications (≈25–35 N·cm). Intervention 2 – Prefabricated abutment group (control): Participants receive the same implant type restored with prefabricated abutments and a screw-retained fixed prosthesis. Torque, Implant system and surgical protocol identical to the test group. Randomisation will be performed with a 1:1 allocation ratio (Multiunit abutment: Prefabricated abutment). A computer-generated random sequence of permuted blocks (block size = 4) will be created by an independent statistician who is not involved in patient enrolment or outcome assessment. Allocation concealment will be ensured using sequentially numbered, opaque, sealed envelopes (SNOSE) prepared and signed by the independent statistician. Envelopes will be stored in a locked cabinet in the research office. After confirming eligibility and obtaining written informed consent, the enrolling clinician will open the next envelope in sequence to reveal the treatment allocation. The allocation will be recorded in the trial log and the participant’s case report form. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Accuracy of prosthetic adaptation (Passive fit) between implant and abutment components. |
| Key secondary outcome measure(s) |
There are no secondary outcome measures |
| Completion date | 15/12/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 20 Years |
| Upper age limit | 50 Years |
| Sex | All |
| Target sample size at registration | 20 |
| Total final enrolment | 20 |
| Key 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. |
| Key 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 |
| Date of first enrolment | 01/05/2024 |
| Date of final enrolment | 01/12/2024 |
Locations
Countries of recruitment
- Syria
Study participating centre
Damascus
-
Syria
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | Contact: Dr. Hasan Alzoubi, dr.hasan.alzoubi.93@gmail.com Type of data shared: Individual participant data (IPD) including passive fit results. Availability: Data will be available after publication of the primary results. Access criteria: Data will be shared for academic, non-commercial research purposes following a formal request. Consent and ethics: All participants provided informed consent/parental consent. Data will be anonymized before sharing. Restrictions: No ethical or legal restrictions beyond participant confidentiality. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
15/10/2025: Trial's existence confirmed by Damascus University.
