Efficacy of Implant Surface Characteristics in Patients With History of Periodontitis

August 14, 2021 updated by: Benjamín Serrano Torrecilla, Universidad Complutense de Madrid

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28040
        • Facultad de odontología, Complutense University of Madrid

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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. �

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test group
Hybrid surface dental implant
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.
Experimental: Control group
moderately rough surface implant
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change between baseline and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical periodontal outcome measurements change
Time Frame: 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.
Change between baseline and 12 months
Microbiologic outcome measurements change
Time Frame: 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.�
Change between baseline and 12 months
Patient reported outcome measures (PROM's)change
Time Frame: 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.
Change between baseline and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Complutense de Madrid

Collaborators

Ti Care S.L

Investigators

  • Study Chair: Mariano Sanz Alonso, Chair, Universidad Complutense de Madrid

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 13, 2018

Primary Completion (Actual)

July 25, 2021

Study Completion (Actual)

July 25, 2021

Study Registration Dates

First Submitted

August 3, 2021

First Submitted That Met QC Criteria

August 14, 2021

First Posted (Actual)

August 18, 2021

Study Record Updates

Last Update Posted (Actual)

August 18, 2021

Last Update Submitted That Met QC Criteria

August 14, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17.516-R_P

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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