NCT05010382

Efficacy of Implant Surface Characteristics in Patients With History of Periodontitis

Efficacy of Two Dental Implants With Different Surface Characteristics in Patients With History of Periodontitis. A Randomized Controlled Clinical Trial.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Universidad Complutense de Madrid · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Marginal Bone Loss

Interventions

Type	Name	Description
PROCEDURE	Implant placement surgery	Under local anaesthesia, full-thickness mucoperiosteal flaps were elevated, the alveolar ridge measured, and a proper implant dimension (3.75 mm and 4.25 mm diameter; 8 mm, 10 mm and 11.5 mm length) and position selected. After site preparation, each patient was randomly allocated to the test or the control group. Patients in the test group received a modified implant design with the coronal third presenting a machined surface (hybrid surface (HS) group), while in the control group the same implant design with a titanium rough surface up to the implant shoulder was used (rough surface (RS) group). Implants were placed 1 mm sub-crestally. In the case of dehiscence or fenestrations around the implant, the patient was excluded from the study. Once inserted, healing abutments (ranging between 3 -5 mm) were placed, and flaps sutured around the abutments to allow for a transmucosal healing.

Timeline

• Start date: 2018-03-13
• Primary completion: 2021-07-25
• Completion: 2021-07-25
• First posted: 2021-08-18
• Last updated: 2021-08-18

Locations

1 site across 1 country: Spain