Efficacy of Implant Surface Characteristics in Patients With History of Periodontitis
- Conditions
- Marginal Bone Loss
- Interventions
- Procedure: Implant placement surgery
- Registration Number
- NCT05010382
- Lead Sponsor
- Universidad Complutense de Madrid
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
•> 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
- 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. �
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Test group Implant placement surgery Hybrid surface dental implant Control group Implant placement surgery moderately rough surface implant
- Primary Outcome Measures
Name Time Method Radiographic marginal bone levels Change 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 Outcome Measures
Name Time Method Microbiologic outcome measurements change Change between baseline and 12 months Paper points will be inserted to the depth of the peri-implant pocket and kept in place for 15 sec. The points will be transferred into a screw-capped vial, containing 1.5 ml of reduced transport fluid, (RTF) and maintained at -20ºC. Microbiological analysis by means of anaerobic culture will be performed for the determination of counts, proportion and frequency of detection of Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythia, Prevotella intermedia and Fusobacterium nucleatum.�
Clinical periodontal outcome measurements change Change between baseline and 12 months Clinical measurements will be performed at six sites per implant of i) probing depth (PD), ii) marginal mucosa recession assessed as length of the implant crown (CLI; distance from the mucosal margin to the oclusal surface at the mid buccal point), iii) bleeding on probing (BoP) and iv) plaque scores (PI). Finally, peri-implant mucositis, defined as the presence of profuse BoP.
Patient reported outcome measures (PROM's)change Change between baseline and 12 months PROM´s will be assessed by means of a questionnaire comprising 4 items: comfort, appearance, masticatory function and overall satisfaction. Patients will be asked to rate these four aspects according to the following scale: very unsatisfied, unsatisfied, fair, satisfied and very satisfied.
Trial Locations
- Locations (1)
Facultad de odontología, Complutense University of Madrid
🇪🇸Madrid, Spain