Bone Loss
Conditions
Keywords
bone loss, dental implant, bone implant interface, Peri implant Endosseous Healing, Dental implant abutment
Brief summary
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).
Detailed description
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: * Subgroup 2.1: Screw-retained abutment of 1 mm height (18 patients) * Subgroup 2.2: Screw-retained abutment of 2.5 mm height (18 patients) Clinical Parameters and Outcomes * Three-dimensional volumetric changes in hard and soft tissues (Cone-beam computed tomography superposed with digital cast models). * Marginal bone level (MBL) change: Standardized intraoral periapical x-rays will be taken on the day of surgery, 4, 6, 12, 24 and 36 months following surgery. * Probing depth, bleeding on probing and keratinized mucosa width will be measured in the follow-up visits in 3 different points in buccal (Mesial, center and distal). * VAS Scale: The visual analog scale or visual analog scale (VAS).
Interventions
DEVICEDental 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)
Sponsors
Universitat Internacional de Catalunya
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Each patient will be randomly allocated in one of the two groups: test group (n=36) or control group (n=12)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Signed informed consent 2. Overall, healthy subjects 3. Females and males of at least eighteen-years 4. Requiring a minimum of two implants (molar and/or premolar teeth) 5. Adequate oral hygiene (less than 15% FMPS) 6. Able to follow instructions and attend a regular compliance 7. Enough bone to place a standard implant of 4.1 mm diameter.
Exclusion criteria
1. Acute local infection 2. Occlusal overload with parafunctional activity (assessed clinically) 3. Large occlusal discrepancies 4. Untreated periodontal disease assessed by Socransky et al. parameters (≥2mm clinical attachment loss in two consecutive visits within 1 year) 5. Smokers (more than 10 cigarettes/day) 6. Drug and/or alcoholic dependencies 7. Medical conditions contraindicating implant surgery 8. History of head and/or neck radiation 9. Bisphosphonate therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Marginal Bone Loss | After implant loading (baseline)and once every year to 24 months follow-up | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Probing Depth | After implant loading (baseline)and once every year to 36 months follow-up | Measuring this outcomes at 4 different points .(Mesial Buccal, Center Buccal, Distal Buccal and central lingual) (measured in millimeters). |
| Bleeding on Probing | After implant loading (baseline)and once every year to 36 months follow-up | Measuring this outcomes at 4 different points .(Mesial Buccal, Center Buccal, Distal Buccal and central lingual) (measured in millimeters). |
| Keratinized Mucosa Width | After implant loading (baseline)and once every year to 36 months follow-up | Measuring this outcomes at 4 different points .(Mesial Buccal, Center Buccal, Distal Buccal and central lingual) (measured in millimeters). |
Countries
Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Group: Two Stage Approach Implant placement surgery with close screw and sumerge implant approach | 12 |
| Control Group: Two Stage Approach Implant placement surgery with close screw and sumerge implant approach | 24 |
| Test Group: One Stage Approach Implant placement surgery with trans-epithelial abutment | 18 |
| Test Group: One Stage Approach Implant placement surgery with trans-epithelial abutment | 36 |
| Total | 90 |
Baseline characteristics
| Characteristic | Control Group: Two Stage Approach | Test Group: One Stage Approach | Total |
|---|---|---|---|
| Age, Continuous | 70.90 years STANDARD_DEVIATION 9.09 | 63.28 years STANDARD_DEVIATION 9.79 | 65.77 years STANDARD_DEVIATION 10.23 |
| Marginal bone loss | 1.17 millimeters STANDARD_DEVIATION 0.36 | 0.83 millimeters STANDARD_DEVIATION 0.26 | 0.97 millimeters STANDARD_DEVIATION 0.34 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 3 Participants | 6 Participants | 9 Participants |
| Sex: Female, Male Male | 9 Participants | 12 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 18 |
| other Total, other adverse events | 0 / 12 | 0 / 18 |
| serious Total, serious adverse events | 0 / 12 | 0 / 18 |
Outcome results
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.
Time frame: After implant loading (baseline)and once every year to 24 months follow-up
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Marginal Bone Loss | Total implants at 24 months | 1.17 millimeters | Standard Deviation 0.35 |
| Control Group | Marginal Bone Loss | Mesial implant at 24 months | 1.28 millimeters | Standard Deviation 0.47 |
| Control Group | Marginal Bone Loss | Distal implant at 24 months | 1.06 millimeters | Standard Deviation 0.53 |
| Control Group | Marginal Bone Loss | Total implants at 12 months | 1.13 millimeters | Standard Deviation 0.34 |
| Control Group | Marginal Bone Loss | Mesial implant at 12 months | 1.25 millimeters | Standard Deviation 0.46 |
| Control Group | Marginal Bone Loss | Distal implant at 12 months | 0.81 millimeters | Standard Deviation 0.41 |
| Test Group | Marginal Bone Loss | Mesial implant at 12 months | 0.93 millimeters | Standard Deviation 0.38 |
| Test Group | Marginal Bone Loss | Total implants at 24 months | 0.83 millimeters | Standard Deviation 0.25 |
| Test Group | Marginal Bone Loss | Total implants at 12 months | 0.80 millimeters | Standard Deviation 0.26 |
| Test Group | Marginal Bone Loss | Mesial implant at 24 months | 0.96 millimeters | Standard Deviation 0.36 |
| Test Group | Marginal Bone Loss | Distal implant at 12 months | 0.67 millimeters | Standard Deviation 0.27 |
| Test Group | Marginal Bone Loss | Distal implant at 24 months | 0.71 millimeters | Standard Deviation 0.27 |
Secondary
Bleeding on Probing
Measuring this outcomes at 4 different points .(Mesial Buccal, Center Buccal, Distal Buccal and central lingual) (measured in millimeters).
Time frame: After implant loading (baseline)and once every year to 36 months follow-up
Secondary
Keratinized Mucosa Width
Measuring this outcomes at 4 different points .(Mesial Buccal, Center Buccal, Distal Buccal and central lingual) (measured in millimeters).
Time frame: After implant loading (baseline)and once every year to 36 months follow-up
Secondary
Probing Depth
Measuring this outcomes at 4 different points .(Mesial Buccal, Center Buccal, Distal Buccal and central lingual) (measured in millimeters).
Time frame: After implant loading (baseline)and once every year to 36 months follow-up