Efficacy of Implant Surface Characteristics in Patients With History of Periodontitis

Universidad Complutense de Madrid

Status: Completed

Conditions: Marginal Bone Loss

Treatments: Procedure: Implant placement surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT05010382

17.516-R_P

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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. �

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

Test group

Experimental group

Description:

Hybrid surface dental implant

Treatment:

Procedure: Implant placement surgery

Control group

Experimental group

Description:

moderately rough surface implant

Treatment:

Procedure: Implant placement surgery