Immediate Provisional ProsthesisNCT07395167
This Study Aims to Evaluate the Soft Tissue Response and Prosthetic Complications Associated With Three Different Types of Provisional Prosthesis Used in Immediate Loading Full-arch Implant Prosthetic Treatment. The Patients Are Randomly Assigned to the Three Groups to Compare the Clinical Outcomes
A study testing 3D printed provisional full arch prosthesis, Bar reinforced 3D printed provisional full arch prosthesis and Milled PMMA provisional full arch prosthesis in people with Immediate Provisional Prosthesis, run by Mansoura University at 1 site in Egypt.
Trial summary
This study aims to evaluate the soft tissue response and prosthetic complications associated with three different types of provisional prostheses used in immediate loading full-arch implant prosthetic treatment. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Immediate Provisional Prosthesis
- What is being tested?
- 3D printed provisional full arch prosthesis, Bar reinforced 3D printed provisional full arch prosthesis and Milled PMMA provisional full arch prosthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2024to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In good general health. Controlled systemic diseases such as well-managed diabetes or hypertension. Good oral hygiene Adequate bone quality and quantity (Type I-III bone, ≥10mm height, ≥6mm width).
Who cannot join
- Uncontrolled systemic diseases Bone insufficiency Active infection or periodontal disease. Pregnancy. Heavy smokers (>10 cigarettes/day). History of previous implant failure in the same site. Immunocompromised patients (e.g., HIV, recent radiation therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Soft Tissue Response and Prosthetic Complication of Three Different Provisional Prosthesis Used for Immediate Load Full Arch Implant Prosthesis. Randomized Control Clinical Trial
This study aims to evaluate the soft tissue response and prosthetic complications associated with three different types of provisional prostheses used in immediate loading full-arch implant prosthetic treatment. The patients are randomly assigned to the three groups to compare the clinical outcomes and determine which provisional prosthesis provides better soft tissue health and fewer prosthetic complications
- Conditions
- Immediate Provisional Prosthesis
- Being tested
- 3D printed provisional full arch prosthesis, Bar reinforced 3D printed provisional full arch prosthesis, Milled PMMA provisional full arch prosthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D printed provisional full arch prosthesisDevice
patients received 3D printed provisional full arch prosthesis after implant placement
Bar reinforced 3D printed provisional full arch prosthesisDevice
patients received bar reinforced 3D printed provisional full arch prosthesis after implant placement
Milled PMMA provisional full arch prosthesisDevice
patients received Milled PMMA provisional full arch prosthesis after implant placement
| Study group | Role | What they receive |
|---|---|---|
| Printed provisional | Experimental | patients received 3D printed provisional full arch prosthesis Receives: Device: 3D printed provisional full arch prosthesis |
| Bar reinforced provisional | Experimental | patients received Bar reinforced 3D printed provisional full arch prosthesis. Receives: Device: Bar reinforced 3D printed provisional full arch prosthesis |
| Milled provisional | Experimental | patient received Milled PMMA provisional full arch prosthesis. Receives: Device: Milled PMMA provisional full arch prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical evaluation of dental implant (bone Level)
Evaluation included alveolar bone level around implant which is evaluated using periapical x-rays comparing T0 (at implant insertion) to T1 ( at one and half month) and T2 (at three months ) measuring amount of bone resorption around implant
Measured: 3 months
Secondary outcomes (3)
modified plaque index
the Modified Plaque Index (MPI) to assess peri-implant biofilm at four surfaces using scores from 0 (no plaque) to 3 (abundant plaque) using periodontal probe.
Measured: 3 months
the Modified Gingival Index (MGI)
evaluate peri-implant soft tissue inflammation, scored from 0 (healthy mucosa) to 3 (severe inflammation)
Measured: 3 months
peri-implant probing depth (PD)
measured with pressure-sensitive probes, where an increase over time indicates possible bone loss, with an ideal sulcus depth of less than 5 mm to allow effective oral hygiene
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start1 Feb 2024
- Primary completion1 Sep 2024
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immediate Provisional ProsthesisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07395167
- Sponsor's protocol ID
- A08012024RP
- Status last verified
- Dec 2023
- First submitted
- 10 Jan 2026
- Last updated
- 9 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Soft Tissue Response and Prosthetic Complication of Three Different Provisional Prosthesis Used for Immediate Load Full Arch Implant Prosthesis. Randomized Control Clinical Trial
- ClinicalTrials.gov ID
- NCT07395167
- Acronym / sponsor ID
- A08012024RP
- Conditions
- Immediate Provisional Prosthesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 9 Feb 2026 (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.
This study aims to evaluate the soft tissue response and prosthetic complications associated with three different types of provisional prostheses used in immediate loading full-arch implant prosthetic treatment. The patients are randomly assigned to the three groups to compare the clinical outcomes and determine which provisional prosthesis provides better soft tissue health and fewer prosthetic complications
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Printed provisional | Experimental | Device: 3D printed provisional full arch prosthesispatients received 3D printed provisional full arch prosthesis |
| Bar reinforced provisional | Experimental | Device: Bar reinforced 3D printed provisional full arch prosthesispatients received Bar reinforced 3D printed provisional full arch prosthesis. |
| Milled provisional | Experimental | Device: Milled PMMA provisional full arch prosthesispatient received Milled PMMA provisional full arch prosthesis. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- In good general health. Controlled systemic diseases such as well-managed diabetes or hypertension. Good oral hygiene Adequate bone quality and quantity (Type I-III bone, ≥10mm height, ≥6mm width).
Key exclusion criteria (1 listed)
- Uncontrolled systemic diseases Bone insufficiency Active infection or periodontal disease. Pregnancy. Heavy smokers (>10 cigarettes/day). History of previous implant failure in the same site. Immunocompromised patients (e.g., HIV, recent radiation therapy
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 |
|---|---|---|
| 3D printed provisional full arch prosthesispatients received 3D printed provisional full arch prosthesis after implant placement | Device | Printed provisional |
| Bar reinforced 3D printed provisional full arch prosthesispatients received bar reinforced 3D printed provisional full arch prosthesis after implant placement | Device | Bar reinforced provisional |
| Milled PMMA provisional full arch prosthesispatients received Milled PMMA provisional full arch prosthesis after implant placement | Device | Milled provisional |
Primary outcome
clinical evaluation of dental implant (bone Level)
Time frame: 3 months
Evaluation included alveolar bone level around implant which is evaluated using periapical x-rays comparing T0 (at implant insertion) to T1 ( at one and half month) and T2 (at three months ) measuring amount of bone resorption around implant
3 secondary outcomes
modified plaque index
Time frame: 3 months
the Modified Gingival Index (MGI)
Time frame: 3 months
peri-implant probing depth (PD)
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
Related trials for Immediate Provisional Prosthesis
Active, not recruitingObservational study
Immediate Loading of Implants in the Partially or Completely Edentulous Jaw
Jaw, Edentulous, Partially, Jaw, Edentulous
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 3D printed provisional full arch prosthesis, Bar reinforced 3D printed provisional full arch prosthesis and Milled PMMA provisional full arch prosthesis in people with Immediate Provisional Prosthesis, run by Mansoura University at 1 site in Egypt.
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 1 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: finished, as of the sponsor's last update on 9 Feb 2026. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
clinical evaluation of dental implant (bone Level) (time frame: 3 months). 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 Feb 2026.