Clinical trial NCT05010382: Efficacy of Implant Surface Characteristics in Patients With History of Periodontitis
Official title: Efficacy of Two Dental Implants With Different Surface Characteristics in Patients With History of Periodontitis. A Randomized Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Marginal Bone Loss
Keywords: Implant surface
hybrid
Peri-implantitis
Periodontitis
Marginal bone loss
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
Collaborators: name: Ti Care S.L
First posted: 2021-08-18
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will recieve an implant with either hybrid surface (test group) or moderately rough surface (control implants
Primary purpose: TREATMENT

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.


Eligibility criteria: 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. �

Primary outcomes:
measure: Radiographic marginal bone levels Change
timeFrame: Change between baseline and 12 months
Secondary outcomes:
measure: Clinical periodontal outcome measurements change
timeFrame: Change between baseline and 12 months
measure: Microbiologic outcome measurements change
timeFrame: Change between baseline and 12 months
measure: Patient reported outcome measures (PROM's)change
timeFrame: Change between baseline and 12 months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Facultad de odontología, Complutense University of Madrid
Study officials:
affiliation: Universidad Complutense de Madrid
name: Mariano Sanz Alonso, Chair
role: STUDY_CHAIR
References:
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