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A prospective randomized controlled clinical trial will be conducted. Study groups will be assigned as described above. The patients will be randomly divided into two groups in order to study the influence of prosthetic screw abutment in marginal bone loss (MBL) around Bone Level Tapered implants (BLT® Roxolid® SLActive® guided implants, Straumann Dental Implant System, Institut Straumann AG, Basel, Switzerland).
48 patients will be selected with partial edentulism in the maxilla or mandible, requiring two dental implants in the posterior areas (molars and premolars).
Each patient will be randomly allocated in one of the two groups: test group (n=36) or control group (n=12) and all the implants will be placed by residents of the International Master in Oral Surgery and Master in Periodontics of the same University.
Study groups
Group 1: Two stage approach (cover screw in first surgery and healing abutment in second surgery) (12 patients)
Group 2: One stage approach (healing cap over trans-epithelial abutments) (36 patients).Two subgroups according to different trans-epithelial height abutment:
Clinical Parameters and Outcomes
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Active Comparator | Group 1: 2 stage approach (cover screw) (12 patients): cover screw is placed over the dental implants in the first surgery and a second surgery will be performed to expose the implants and placing a healing abutment after 2-4 months, DEVICES: COVER SCREW (first surgery) and HEALING ABUTMENT (second surgery) |
|
| Test group | Experimental | Group 2: Protective plastic cap over different definitive trans-epithelial abutments are placed in the unic surgery performed (36 patients): Definitive transepithelial abutments will be placed the same day of the implant placement surgery. DEVICE: DEFINITIVE TRANSEPITHELIAL ABUTMENT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dental implant placement with COVER SCREW (two surgeries in control group) or DEFINITIVE TRANSEPITHELIAL ABUTMENT (one surgery in test group) | Device | Dental implant placement using cover screws (first surgery) and a healing abutment (second surgery) or definitive transepithelial abutments the same day of the implant placement (one unit surgery) |
| Measure | Description | Time Frame |
|---|---|---|
| Marginal Bone Loss | Periimplant bone level by measuring from the implant platform to the first bone to implant contact. Messuret in 2 points: MESIAL AND DISTAL with intra-oral XR. (measured in millimeters). The mean of this two-points for each implant was calculated. Afterwards, the mean for the mesial implants, distal and total implant sample per group was calculated. | After implant loading (baseline)and once every year to 24 months follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Probing Depth | Measuring this outcomes at 4 different points .(Mesial Buccal, Center Buccal, Distal Buccal and central lingual) (measured in millimeters). | After implant loading (baseline)and once every year to 36 months follow-up |
| Bleeding on Probing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jordi Gargallo-Albiol | Universitat Internacional de Catalunya | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitat Internacional de Catalunya | Barcelona | 08195 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42226307 | Derived | Gargallo-Albiol J, Zilleruelo-Pozo MJ, Treserra-Parra A, Lucas-Taule E, Paternostro-Betancourt D, Hernandez-Alfaro F. Marginal Bone Loss Around Bone-Level Fully Guided Implants With Direct Implant Connection Versus Intermediate Abutment: A Randomized Clinical Trial. Clin Oral Implants Res. 2026 Jun 1. doi: 10.1111/clr.70141. Online ahead of print. |
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The investigators will have all the informed consent forms, the clinical study report, the presurgical plan, the CBCT immediately post-surgery, and the outcome variable tables of each follow-up visit.
The first outcome will be available in July-2022 and the last outcome in July.2024
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Group | Group 1: 2 stage approach (cover screw) (12 patients): cover screw is placed over the dental implants in the first surgery and a second surgery will be performed to expose the implants and placing a healing abutment after 2-4 months, DEVICES: COVER SCREW (first surgery) and HEALING ABUTMENT (second surgery) Dental implant placement with COVER SCREW (two surgeries in control group) or DEFINITIVE TRANSEPITHELIAL ABUTMENT (one surgery in test group): Dental implant placement using cover screws (first surgery) and a healing abutment (second surgery) or definitive transepithelial abutments the same day of the implant placement (one unit surgery) |
| FG001 | Test Group | Group 2: Protective plastic cap over different definitive trans-epithelial abutments are placed in the unic surgery performed (36 patients): Definitive transepithelial abutments will be placed the same day of the implant placement surgery. DEVICE: DEFINITIVE TRANSEPITHELIAL ABUTMENT Dental implant placement with COVER SCREW (two surgeries in control group) or DEFINITIVE TRANSEPITHELIAL ABUTMENT (one surgery in test group): Dental implant placement using cover screws (first surgery) and a healing abutment (second surgery) or definitive transepithelial abutments the same day of the implant placement (one unit surgery) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
A total of 30 patients (12 of the control group and 18 of the test group) started the study and complete the 24 months of follow-up.
| ID | Title | Description |
|---|---|---|
| BG000 | Control Group: Two Stage Approach | Implant placement surgery with close screw and sumerge implant approach |
| BG001 | Test Group: One Stage Approach | Implant placement surgery with trans-epithelial abutment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Marginal Bone Loss | Periimplant bone level by measuring from the implant platform to the first bone to implant contact. Messuret in 2 points: MESIAL AND DISTAL with intra-oral XR. (measured in millimeters). The mean of this two-points for each implant was calculated. Afterwards, the mean for the mesial implants, distal and total implant sample per group was calculated. | A total of 30 patients (60 implants), 12 of the control group (24 implants) and 18 of the test group (36 implants) were assessed after 24 months follow-up. | Posted | Mean | Standard Deviation | millimeters | After implant loading (baseline)and once every year to 24 months follow-up | implants | implants |
|
24 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Group | Group 1: 2 stage approach (cover screw) (12 patients): cover screw is placed over the dental implants in the first surgery and a second surgery will be performed to expose the implants and placing a healing abutment after 2-4 months, DEVICES: COVER SCREW (first surgery) and HEALING ABUTMENT (second surgery) Dental implant placement with COVER SCREW (two surgeries in control group) or DEFINITIVE TRANSEPITHELIAL ABUTMENT (one surgery in test group): Dental implant placement using cover screws (first surgery) and a healing abutment (second surgery) or definitive transepithelial abutments the same day of the implant placement (one unit surgery) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jordi Gargallo | Universitat Internacional de Catalunya | +34 935 04 20 00 | jgargallo@uic.es |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 7, 2017 | Mar 29, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 7, 2017 | Feb 23, 2025 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 7, 2017 | Mar 30, 2025 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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Each patient will be randomly allocated in one of the two groups: test group (n=36) or control group (n=12)
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|
Measuring this outcomes at 4 different points .(Mesial Buccal, Center Buccal, Distal Buccal and central lingual) (measured in millimeters). |
| After implant loading (baseline)and once every year to 36 months follow-up |
| Keratinized Mucosa Width | Measuring this outcomes at 4 different points .(Mesial Buccal, Center Buccal, Distal Buccal and central lingual) (measured in millimeters). | After implant loading (baseline)and once every year to 36 months follow-up |
| BG002 | Total | Total of all reporting groups |
| implant |
|
| years |
| Participants |
|
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
|
|
| Marginal bone loss | Mean | Standard Deviation | millimeters | implant |
|
|
| OG001 | Test Group | Group 2: Protective plastic cap over different definitive trans-epithelial abutments are placed in the unic surgery performed (36 patients): Definitive transepithelial abutments will be placed the same day of the implant placement surgery. DEVICE: DEFINITIVE TRANSEPITHELIAL ABUTMENT Dental implant placement with COVER SCREW (two surgeries in control group) or DEFINITIVE TRANSEPITHELIAL ABUTMENT (one surgery in test group): Dental implant placement using cover screws (first surgery) and a healing abutment (second surgery) or definitive transepithelial abutments the same day of the implant placement (one unit surgery) |
|
|
| Secondary | Probing Depth | Measuring this outcomes at 4 different points .(Mesial Buccal, Center Buccal, Distal Buccal and central lingual) (measured in millimeters). | Not Posted | After implant loading (baseline)and once every year to 36 months follow-up | Participants |
| Secondary | Bleeding on Probing | Measuring this outcomes at 4 different points .(Mesial Buccal, Center Buccal, Distal Buccal and central lingual) (measured in millimeters). | Not Posted | After implant loading (baseline)and once every year to 36 months follow-up | Participants |
| Secondary | Keratinized Mucosa Width | Measuring this outcomes at 4 different points .(Mesial Buccal, Center Buccal, Distal Buccal and central lingual) (measured in millimeters). | Not Posted | After implant loading (baseline)and once every year to 36 months follow-up | Participants |
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Test Group | Group 2: Protective plastic cap over different definitive trans-epithelial abutments are placed in the unic surgery performed (36 patients): Definitive transepithelial abutments will be placed the same day of the implant placement surgery. DEVICE: DEFINITIVE TRANSEPITHELIAL ABUTMENT Dental implant placement with COVER SCREW (two surgeries in control group) or DEFINITIVE TRANSEPITHELIAL ABUTMENT (one surgery in test group): Dental implant placement using cover screws (first surgery) and a healing abutment (second surgery) or definitive transepithelial abutments the same day of the implant placement (one unit surgery) | 0 | 18 | 0 | 18 | 0 | 18 |
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| D008722 | Methods |