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Comparing the loss of bone around Straumann BLT® implants with direct connection to the implant versus those with an intermediate connection

Evaluation of the marginal bone level change of Straumann Bone Level Tapered® implants using different screwed abutment height in partially edentulous patients: a randomized controlled clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN12525141
Enrollment
98
Registered
2023-05-26
Start date
2017-06-01
Completion date
Unknown
Last updated
2023-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention of marginal bone loss around fixed implant restorations in partially edentulous patients Oral Health

Interventions

Patients with partial edentulism attending the International University of Catalonia, School of Dentistry, requiring a total of 2 implants in the posterior maxilla or mandible (molar and/or premolar a
2) Test group (screw retained abutment). The test group was also divided into two subgroups according to two abutment heights: 1mm height abutment (7 patients) and 2.5mm abutment heigh
using ImageJ® software by one calibrated examiner (M.Z). The randomization sequence will be created by means of computer-generated randomization codes and concealed in sealed non-tran

Sponsors

Universitat Internacional de Catalunya
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Secondary

MeasureTime frame
Probing depth, bleeding on probing and keratinized mucosa width will be measured at the day of surgery, 4, 6, 12, 24 and 36 months following surgery in 3 different buccal points (M, C and D)

Primary

MeasureTime frame
Marginal bone level (MBL) change: Standardized intraoral periapical x-rays will be taken at the day of surgery, 4, 6, 12, 24 and 36 months following surgery. These will be used to measure the periimplant bone level by measuring from the implant platform to the first bone to implant contact. Measurements will be performed using Image J by one calibrated examiner. Implant threads will be used for normalization of the images.

Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026