Influence of the Implant-prosthetic Connection in the Marginal Bone Loss and Bacterial Leakage. A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- University of Barcelona
- Enrollment
- 105
- Locations
- 2
- Primary Endpoint
- Change in Vertical Marginal Bone Loss (VMBL)
Study Overview
Brief Summary
This study consists in a double-blinded randomized controlled trial which objective is to assess the effect of the implant-abutment connection type -external hexagon, internal hexagon and conical connection- in the periimplant marginal bone loss in vertical side and the bacterial leakage 12 months after prosthesis placement.
Detailed Description
Location: This study is going to take place in the Dentistry Hospital of the University of Barcelona (Campus of Bellvitge).
Study subjects: The sample (105 patients) consists of patients with single tooth edentulous spaces or posterior maxillary and/or mandible edentulous spaces in need of dental implants with screw-retained single fixed crowns. All of them are being properly informed about the study according to the Comité Ético (CEIC) del Hospital Odontològic Universitat de Barcelona guidelines, and informed consent must be signed prior to the interventions.
Material: Registration papers for the study, dental implants, surgery material, prosthetic components, Florida Probe Software®, Periapical x-rays, computer, Software Stata 14 and Software ImageJ®.
Determinations: Clinical, radiographic and microbiologic measures since implant placement, prosthesis placement and 3, 6, 9 and 12 months after it.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
Patient will not know the type of connection of his or her implant until the study has finished. Outcome Assessor will be blinded. In the radiographic evaluation the implant-abutment connection will be hidden to assess the marginal bone loss.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Subjects who accept signing voluntarily the informed consent before doing any action related to the study.
- •≥18-years-old patients.
- •Edentulous single spaces or edentulous posterior maxilla or mandible (from the first premolar to the second molar) with screw-retained single fixed crowns.
- •Single implants successfully osseointegrated placed at least 16 weeks post-extraction.
- •O'Leary plaque index and or bleeding on probing ≤25%.
- •Dental implants with screwed-retained prosthesis.
Exclusion Criteria
- •Systemic diseases that can interfere dental implant placement.
- •Any contraindication for surgery procedures.
- •Heavy smokers (> 20cig/day).
- •Background of drug abuse or other factors such as psychiatric diseases that, in opinion of the examiner, could interfere with the ability of the patient to cooperate and compliment with the study.
- •Patients who have had participated with another clinical trial the last 30 days.
- •Pregnant women or in lactation.
- •Patients with bad oral hygiene or not motivated.
- •Probing pockets depths with bleeding of ≥4 mm on a tooth adjacent to the edentulous space.
- •Guided bone regeneration required in the same time of the implant placement.
Outcomes
Primary Outcomes
Change in Vertical Marginal Bone Loss (VMBL)
Time Frame: Since implant placement (Timing 0) through study completion (Timing 5), an average of 1 year.
Distance in millimetres between the implant platform and the point of the intra-bone defect that is more apical.
Secondary Outcomes
- Early implant failure(Since implant placement (Timing 0) through prosthesis placement (Timing 1).)
- Late implant failure(Since prosthesis placement (Timing 1) through study completion (Timing 5), an average of 1 year.)
- Vertical Marginal Bone Loss Tax(12 months after prosthesis placement.)
- Prosthetic complications(Since prosthesis placement (Timing 1) through study completion (Timing 5), an average of 1 year.)
- Bacterial leakage(12 months after prosthesis placement.)
- Probing pocket depth(Since prosthesis placement (Timing 1) through study completion (Timing 5), an average of 1 year.)
- Mucosal recession(Since prosthesis placement (Timing 1) through study completion (Timing 5), an average of 1 year.)
- Mucosal hyperplasia(Since prosthesis placement (Timing 1) through study completion (Timing 5), an average of 1 year.)
- Clinical attachment level(Since prosthesis placement (Timing 1) through study completion (Timing 5), an average of 1 year.)
- O'Leary plaque index(First visit)
- Bleeding on probing(Since first visit through study completion (Timing 5), an average of 1 year.)
- Suppuration on probing(Since first visit through study completion (Timing 5), an average of 1 year.)
Investigators
Octavi Camps-Font
Professor
University of Barcelona