Efficacy of Two Dental Implants With Different Surface Characteristics in Patients With History of Periodontitis. A Randomized Controlled Clinical Trial.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Radiographic marginal bone levels Change
Study Overview
Brief Summary
The aim of the study is to evaluate in patients with history of periodontitis the clinical, microbiological and radiological outcomes of implants with a modified implant design consisting on a machined surface in the coronal third of the implant.
In this 12-month, parallel-arm, randomized controlled trial, patients with history of treated periodontitis and in need of dental implants for single-unit or short edentulous spaces (i.e. two implants) will be randomly assigned to a test group (implants with a hybrid surface, presenting a machined coronal third; HS) or a control group (conventional moderately rough implants; RS). Implants will be restored 3 months later with fixed implant supported reconstructions. Radiological, clinical, microbiological and patient-related outcome measures (PROMs) will be assessed 3, 6 and 12 months after the prosthetic installation.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •> 20 years of age
- •Presence of ≥1 adjacent missing teeth, in either maxilla or mandible (up to three missing units).
- •A natural tooth had to be present mesially to the most proximal implant site, although free end situations were allowed, and opposing dentition had to be natural teeth or implant supported fixed restorations.
- •History of treated and controlled periodontitis.
- •Presence of adequate bone volume to achieve primary implant stability without concomitant regeneration
Exclusion Criteria
- •Diseases affecting bone metabolism or wound healing (e.g.)
- •History of radiation therapy, leukocyte dysfunction, or any other immunodeficiency
- •Drug abuse
- •Intrasurgical exclusion criteria, such as the lack of primary stability, the need of bone augmentation or the impossibility of placing the implant based on prosthetic requirements. �
Arms & Interventions
Test group
Hybrid surface dental implant
Intervention: Implant placement surgery (Procedure)
Control group
moderately rough surface implant
Intervention: Implant placement surgery (Procedure)
Outcomes
Primary Outcomes
Radiographic marginal bone levels Change
Time Frame: Change between baseline and 12 months
Radiographic marginal bone levels (bone loss) are defined as the distance between the bone crest and the implant shoulder at mesial and distal sites. For standardization of periapical radiographs the same film holder-beam aiming device will be applied (Rinn System) and silicone custom-made bite blocks will be used to improve reproducible repositioning. All digital radiographs will be evaluated by one calibrated and trained researcher (BS) using a software (AutoCAD® Autodesk ®, California, USA) that allows to calibrate the distances using the known implant length.
Secondary Outcomes
- Microbiologic outcome measurements change(Change between baseline and 12 months)
- Clinical periodontal outcome measurements change(Change between baseline and 12 months)
- Patient reported outcome measures (PROM's)change(Change between baseline and 12 months)
Investigators
Benjamín Serrano Torrecilla
Doctorate student
Universidad Complutense de Madrid