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

Not Applicable

• Conditions: Prevention of marginal bone loss around fixed implant restorations in partially edentulous patients; Oral Health

• Registration Number: ISRCTN12525141
• Lead Sponsor: niversitat Internacional de Catalunya

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-05-26
• Last Update Posted: 5 June 2023
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 98

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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)