EdentulismNCT07107464
Subcrestal vs Juxtacrestal PRAMA Implants With Variable Necks
A study testing Short Neck Implant - Crestal Placement, Standard Neck Implant - 1 mm Subcrestal Placement and Long Neck Implant - 2 mm Subcrestal Placement in people with Edentulism and Dental Implantation, Endosseous, run by ARDEC Academy at 1 site in Cuba.
Trial summary
The goal of this clinical trial is to understand how different implant neck designs and placement depths affect the surrounding bone and peri-implant tissue (the tissue around a dental implant) in adults who need implants in the back areas of the mouth (molars and premolars). Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Edentulism, Dental Implantation, Endosseous, Marginal Bone Loss
- What is being tested?
- Short Neck Implant - Crestal Placement, Standard Neck Implant - 1 mm Subcrestal Placement and Long Neck Implant - 2 mm Subcrestal Placement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCuba
- Study dates
- 3 Jun 2024to 1 Jul 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 21 years or older.
- Presence of an edentulous area in the posterior maxilla or mandible (premolar or molar region) that allows the placement of two dental implants.
- Alveolar bone height sufficient to permit implant insertion with a minimum depth of 6 mm, and total implant length of at least 10 mm.
- Indication for implant-supported prosthetic restoration (2- or 3-unit fixed dental bridge).
- Good general health with no contraindications for oral surgical procedures.
- Not pregnant at the time of screening.
- Willingness and ability to sign written informed consent and comply with study procedures.
Who cannot join
- Presence of uncontrolled systemic disease (e.g., diabetes, cardiovascular disorders, immunosuppression).
- History of chemotherapy or radiotherapy to the head or neck region.
- Heavy smokers (defined as >10 cigarettes per day)
- Previous bone regeneration or grafting procedures at the target implant site.
- Use of medications known to interfere with bone metabolism (e.g., bisphosphonates, corticosteroids).
- Poor oral hygiene or active periodontal disease that may compromise implant success.
- -Known allergy or hypersensitivity to implant materials used in the study-
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Subcrestal Placement of PRAMA Implants With Convergent Neck Incorporating Ultrathin Threaded Microsurface: A Randomized Controlled Clinical Trial
The goal of this clinical trial is to understand how different implant neck designs and placement depths affect the surrounding bone and peri-implant tissue (the tissue around a dental implant) in adults who need implants in the back areas of the mouth (molars and premolars). The main questions it aims to answer are:
Does placing implants deeper under the bone crest (subcrestally) help preserve more bone and peri-implant tissue over time? Do implants with longer, conical necks and micro-threaded surfaces result in more stable peri-implant tissue than implants with shorter necks? Researchers will compare three types of one-piece dental implants with different neck heights (short, standard, and long), placed at different depths in the jawbone, to determine which combination better maintains bone and peri-implant tissue levels.
Read more
Participants will:
Receive two dental implants in the posterior upper or lower jaw Be randomly assigned to one of three groups depending on implant neck design and placement depth Undergo implant surgery using a digital workflow, with healing over three months Be rehabilitated with custom zirconia bridges Return for regular clinical and imaging checkups over a period of at least 3 years This study aims to generate evidence that helps clinicians choose implant designs and techniques that promote long-term peri-implant tissue health.
Read the detailed description
This randomized controlled clinical trial investigates the impact of different transmucosal neck configurations and vertical placement levels of one-piece dental implants on peri-implant hard and soft tissue stability over time. The trial specifically focuses on the PRAMA implant system (Sweden \& Martina, Italy), which incorporates a ZirTi surface and a convergent neck design with an Ultrathin Threaded Microsurface (UTM). These implants are designed to optimize tissue integration and minimize marginal bone loss.
The study explores how subcrestal versus crestal placement of the rough-to-smooth transition, combined with variable neck lengths, influences peri-implant tissue outcomes under functional loading in posterior edentulous sites. Three types of PRAMA implants will be compared:
Short neck (1.8 mm total length with hyperbolic convergent shape)
Standard neck (0.8 mm cylindrical plus 2.0 mm convergent portion)
Long neck (0.8 mm cylindrical plus 3.0 mm convergent portion)
Each patient will receive two implants to support a 2- or 3-unit prosthetic bridge. The neck design determines the depth of implant placement:
Short group: coronal rough surface margin placed at bone crest (crestal placement)
Standard group: 1 mm subcrestal placement
Long group: 2 mm subcrestal placement
The trial adopts a parallel design, with a sample size of 30 patients (10 per group), allowing for adequate power while considering possible dropouts. Randomization will be performed electronically and concealed in opaque envelopes until surgery. Blinding is partially feasible, especially for radiographic and digital analysis where treatment allocation is masked.
Surgical procedures will be standardized using a fully digital workflow. Implants will be placed in healed sites without the need for bone grafting. Healing will be non-submerged using appropriate healing abutments. After three months, definitive zirconia bridges will be installed, and patients will be enrolled in a maintenance protocol.
In addition to comparing the impact of different neck designs and placement depths, the prosthetic crowns will be designed with two distinct emergence profiles: one simulating a natural root form extending apically, and the other adapted to the mucosal margin. This design will allow for the assessment of volumetric tissue adaptation based on prosthetic contour.
Primary outcomes will include longitudinal changes in marginal bone height evaluated through standardized periapical radiographs, CBCT, and digital scans. Secondary outcomes include:
Volumetric soft tissue changes assessed using superimposed 3D models derived from intraoral scans.
Comparison of tissue responses between the two crown designs (root-form vs. standard emergence).
Clinical parameters such as probing depth, plaque index, and bleeding on probing at designated follow-ups.
Radiographic and volumetric measurements will be performed by calibrated, blinded examiners. Imaging will be taken at baseline (prosthesis delivery), 6 months, and annually up to 3 years. Analytical methods include ANOVA or Kruskal-Wallis tests based on data distribution, with appropriate post-hoc comparisons and a significance level set at p < 0.05.
This study is expected to contribute relevant clinical data to the ongoing discussion around subcrestal implant placement and the role of implant macro- and micro-geometry in maintaining peri-implant tissue health.
- Being tested
- Short Neck Implant - Crestal Placement, Standard Neck Implant - 1 mm Subcrestal Placement, Long Neck Implant - 2 mm Subcrestal Placement
- Keywords
- edentulism, dental implants, Peri-Implant Bone Loss, Subcrestal Implant Placement, One-Piece Implants, Implant Neck Design, Convergent Implant Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short Neck Implant - Crestal PlacementDevice
A one-piece endosseous dental implant with a 1.8 mm short convergent neck, placed at the bone crest. Implant used: PRAMA implant (Sweden \& Martina, Italy) with UTM surface treatment.
Standard Neck Implant - 1 mm Subcrestal PlacementDevice
A one-piece endosseous dental implant with a standard-length neck (2.8 mm total; 0.8 mm cylindrical + 2 mm convergent), placed 1 mm subcrestally. Implant used: PRAMA implant (Sweden \& Martina, Italy) with UTM surface.
Long Neck Implant - 2 mm Subcrestal PlacementDevice
A one-piece endosseous dental implant with a long transmucosal neck (3.8 mm total; 0.8 mm cylindrical + 3 mm convergent), placed 2 mm subcrestally. Implant used: PRAMA implant (Sweden \& Martina, Italy) with UTM surface.
| Study group | Role | What they receive |
|---|---|---|
| Short Neck Implant - Crestal Placement | Experimental | Participants in this arm receive one-piece dental implants with a short transmucosal neck (1.8 mm total height, hyperbolic convergent shape) placed at the level of the bone crest (crestal placement). The implant features a ZirTi surface and Ultrathin Threaded Microsurface across the entire neck. Receives: Device: Short Neck Implant - Crestal Placement |
| Standard Neck Implant (1 mm Subcrestal Placement) | Experimental | Participants in this arm receive one-piece dental implants with a standard transmucosal neck (0.8 mm cylindrical plus 2.0 mm convergent portion) placed 1 mm below the bone crest. The implant surface includes micro-threads throughout the neck to promote tissue stability. Receives: Device: Standard Neck Implant - 1 mm Subcrestal Placement |
| Long Neck Implant (2 mm Subcrestal Placement) | Experimental | Participants in this arm receive one-piece dental implants with a long transmucosal neck (0.8 mm cylindrical plus 3.0 mm convergent portion) placed 2 mm below the bone crest. This arm tests the effect of deeper placement combined with extended neck geometry. Receives: Device: Long Neck Implant - 2 mm Subcrestal Placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Peri-Implant Bone Height Over Time
Vertical changes in marginal bone level from the implant-abutment junction to the first bone-to-implant contact (BIC) at mesial and distal aspects, measured on standardized periapical radiographs, CBCT, and digital scans.
Unit of Measure: Millimeters (mm)
Measured: Baseline (prosthesis delivery), 6 months, and annually up to 3 years post-loading
Secondary outcomes (5)
Volumetric Change in Peri-Implant Tissues
Volumetric changes in peri-implant soft and hard tissues will be measured using 3D digital superimposition of intraoral scans. The analysis will compare changes over time in tissue volume surrounding each implant. Unit of Measure: Cubic millimeters (mm³)
Measured: Baseline (prosthesis delivery), 6 months, and annually up to 3 years post-loading
Tissue Volume Difference by Crown Emergence Profile
Comparison of peri-implant tissue volume changes between crowns with root-shaped apical emergence profiles versus standard crown shapes.
Unit of Measure: Cubic millimeters (mm³)
Measured: 6 months and annually up to 3 years post-loading
Probing Pocket Depth at Implant Sites
Probing depth at six sites per implant to evaluate peri-implant health. Unit of Measure: Millimeters (mm)
Measured: 6 months and annually up to 3 years post-loading
Plaque Index at Implant Sites (0-3 scale)
Plaque accumulation at implant sites assessed with a modified plaque index. Unit of Measure: Score on index scale (0-3)
Measured: 6 months and annually up to 3 years
Bleeding on Probing at Implant Sites (percentage of sites)
Presence of bleeding upon probing at six sites per implant. Unit of Measure: Percentage (%)
Measured: 6 months and annually up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start3 Jun 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EdentulismStudies 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
- Model description
- Split-mouth randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ARDEC Academy
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07107464
- Sponsor's protocol ID
- 2024/02
- Status last verified
- Aug 2025
- First submitted
- 19 Jul 2025
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to institutional policy and ethical considerations regarding patient confidentiality. Only aggregate-level results will be made publicly available through publications and study reports.
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subcrestal Placement of PRAMA Implants With Convergent Neck Incorporating Ultrathin Threaded Microsurface: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07107464
- Acronym / sponsor ID
- 2024/02
- Keywords
- edentulism, dental implants, Peri-Implant Bone Loss, Subcrestal Implant Placement, One-Piece Implants, Implant Neck Design, Convergent Implant Neck
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- ARDEC AcademyResearch network
- Study start
- 3 Jun 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 6 Aug 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.
The goal of this clinical trial is to understand how different implant neck designs and placement depths affect the surrounding bone and peri-implant tissue (the tissue around a dental implant) in adults who need implants in the back areas of the mouth (molars and premolars). The main questions it aims to answer are:
Does placing implants deeper under the bone crest (subcrestally) help preserve more bone and peri-implant tissue over time? Do implants with longer, conical necks and micro-threaded surfaces result in more stable peri-implant tissue than implants with shorter necks? Researchers will compare three types of one-piece dental implants with different neck heights (short, standard, and long), placed at different depths in the jawbone, to determine which combination better maintains bone and peri-implant tissue levels.
Participants will:
Receive two dental implants in the posterior upper or lower jaw Be randomly assigned to one of three groups depending on implant neck design and placement depth Undergo implant surgery using a digital workflow, with healing over three months Be rehabilitated with custom zirconia bridges Return for regular clinical and imaging checkups over a period of at least 3 years This study aims to generate evidence that helps clinicians choose implant designs and techniques that promote long-term peri-implant tissue health.
Detailed description
This randomized controlled clinical trial investigates the impact of different transmucosal neck configurations and vertical placement levels of one-piece dental implants on peri-implant hard and soft tissue stability over time. The trial specifically focuses on the PRAMA implant system (Sweden \& Martina, Italy), which incorporates a ZirTi surface and a convergent neck design with an Ultrathin Threaded Microsurface (UTM). These implants are designed to optimize tissue integration and minimize marginal bone loss.
The study explores how subcrestal versus crestal placement of the rough-to-smooth transition, combined with variable neck lengths, influences peri-implant tissue outcomes under functional loading in posterior edentulous sites. Three types of PRAMA implants will be compared:
Short neck (1.8 mm total length with hyperbolic convergent shape)
Standard neck (0.8 mm cylindrical plus 2.0 mm convergent portion)
Long neck (0.8 mm cylindrical plus 3.0 mm convergent portion)
Each patient will receive two implants to support a 2- or 3-unit prosthetic bridge. The neck design determines the depth of implant placement:
Short group: coronal rough surface margin placed at bone crest (crestal placement)
Standard group: 1 mm subcrestal placement
Long group: 2 mm subcrestal placement
The trial adopts a parallel design, with a sample size of 30 patients (10 per group), allowing for adequate power while considering possible dropouts. Randomization will be performed electronically and concealed in opaque envelopes until surgery. Blinding is partially feasible, especially for radiographic and digital analysis where treatment allocation is masked.
Surgical procedures will be standardized using a fully digital workflow. Implants will be placed in healed sites without the need for bone grafting. Healing will be non-submerged using appropriate healing abutments. After three months, definitive zirconia bridges will be installed, and patients will be enrolled in a maintenance protocol.
In addition to comparing the impact of different neck designs and placement depths, the prosthetic crowns will be designed with two distinct emergence profiles: one simulating a natural root form extending apically, and the other adapted to the mucosal margin. This design will allow for the assessment of volumetric tissue adaptation based on prosthetic contour.
Primary outcomes will include longitudinal changes in marginal bone height evaluated through standardized periapical radiographs, CBCT, and digital scans. Secondary outcomes include:
Volumetric soft tissue changes assessed using superimposed 3D models derived from intraoral scans.
Comparison of tissue responses between the two crown designs (root-form vs. standard emergence).
Clinical parameters such as probing depth, plaque index, and bleeding on probing at designated follow-ups.
Radiographic and volumetric measurements will be performed by calibrated, blinded examiners. Imaging will be taken at baseline (prosthesis delivery), 6 months, and annually up to 3 years. Analytical methods include ANOVA or Kruskal-Wallis tests based on data distribution, with appropriate post-hoc comparisons and a significance level set at p < 0.05.
This study is expected to contribute relevant clinical data to the ongoing discussion around subcrestal implant placement and the role of implant macro- and micro-geometry in maintaining peri-implant tissue health.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Split-mouth randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Short Neck Implant - Crestal Placement | Experimental | Device: Short Neck Implant - Crestal PlacementParticipants in this arm receive one-piece dental implants with a short transmucosal neck (1.8 mm total height, hyperbolic convergent shape) placed at the level of the bone crest (crestal placement). The implant features a ZirTi surface and Ultrathin Threaded Microsurface across the entire neck. |
| Standard Neck Implant (1 mm Subcrestal Placement) | Experimental | Device: Standard Neck Implant - 1 mm Subcrestal PlacementParticipants in this arm receive one-piece dental implants with a standard transmucosal neck (0.8 mm cylindrical plus 2.0 mm convergent portion) placed 1 mm below the bone crest. The implant surface includes micro-threads throughout the neck to promote tissue stability. |
| Long Neck Implant (2 mm Subcrestal Placement) | Experimental | Device: Long Neck Implant - 2 mm Subcrestal PlacementParticipants in this arm receive one-piece dental implants with a long transmucosal neck (0.8 mm cylindrical plus 3.0 mm convergent portion) placed 2 mm below the bone crest. This arm tests the effect of deeper placement combined with extended neck geometry. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults aged 21 years or older.
- Presence of an edentulous area in the posterior maxilla or mandible (premolar or molar region) that allows the placement of two dental implants.
- Alveolar bone height sufficient to permit implant insertion with a minimum depth of 6 mm, and total implant length of at least 10 mm.
- Indication for implant-supported prosthetic restoration (2- or 3-unit fixed dental bridge).
- Good general health with no contraindications for oral surgical procedures.
Key exclusion criteria (7 listed)
- Presence of uncontrolled systemic disease (e.g., diabetes, cardiovascular disorders, immunosuppression).
- History of chemotherapy or radiotherapy to the head or neck region.
- Heavy smokers (defined as >10 cigarettes per day)
- Previous bone regeneration or grafting procedures at the target implant site.
- Use of medications known to interfere with bone metabolism (e.g., bisphosphonates, corticosteroids).
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 |
|---|---|---|
| Short Neck Implant - Crestal PlacementA one-piece endosseous dental implant with a 1.8 mm short convergent neck, placed at the bone crest. Implant used: PRAMA implant (Sweden \& Martina, Italy) with UTM surface treatment. | Device | Short Neck Implant - Crestal Placement |
| Standard Neck Implant - 1 mm Subcrestal PlacementA one-piece endosseous dental implant with a standard-length neck (2.8 mm total; 0.8 mm cylindrical + 2 mm convergent), placed 1 mm subcrestally. Implant used: PRAMA implant (Sweden \& Martina, Italy) with UTM surface. | Device | Standard Neck Implant (1 mm Subcrestal Placement) |
| Long Neck Implant - 2 mm Subcrestal PlacementA one-piece endosseous dental implant with a long transmucosal neck (3.8 mm total; 0.8 mm cylindrical + 3 mm convergent), placed 2 mm subcrestally. Implant used: PRAMA implant (Sweden \& Martina, Italy) with UTM surface. | Device | Long Neck Implant (2 mm Subcrestal Placement) |
Primary outcome
Change in Peri-Implant Bone Height Over Time
Time frame: Baseline (prosthesis delivery), 6 months, and annually up to 3 years post-loading
Vertical changes in marginal bone level from the implant-abutment junction to the first bone-to-implant contact (BIC) at mesial and distal aspects, measured on standardized periapical radiographs, CBCT, and digital scans. Unit of Measure: Millimeters (mm)
5 secondary outcomes
Volumetric Change in Peri-Implant Tissues
Time frame: Baseline (prosthesis delivery), 6 months, and annually up to 3 years post-loading
Tissue Volume Difference by Crown Emergence Profile
Time frame: 6 months and annually up to 3 years post-loading
Probing Pocket Depth at Implant Sites
Time frame: 6 months and annually up to 3 years post-loading
Plaque Index at Implant Sites (0-3 scale)
Time frame: 6 months and annually up to 3 years
Bleeding on Probing at Implant Sites (percentage of sites)
Time frame: 6 months and annually up to 3 years
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 6 Aug 2025.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to institutional policy and ethical considerations regarding patient confidentiality. Only aggregate-level results will be made publicly available through publications and study reports.
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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 Short Neck Implant - Crestal Placement, Standard Neck Implant - 1 mm Subcrestal Placement and Long Neck Implant - 2 mm Subcrestal Placement in people with Edentulism and Dental Implantation, Endosseous, run by ARDEC Academy at 1 site in Cuba.
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 7 inclusion and 7 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 6 Aug 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 Cuba. 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?
Change in Peri-Implant Bone Height Over Time (time frame: Baseline (prosthesis delivery), 6 months, and annually up to 3 years post-loading). 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 6 Aug 2025.