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Clinical Trials/NCT02842385
NCT02842385
Completed
Not Applicable

The Influence of Soft Tissue Thickness On Crestal Bone Changes Around Submerged and Nonsubmerged Implants: A Randomized Prospective Clinical Study

Ege University0 sites35 target enrollmentOctober 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Tooth Loss
Sponsor
Ege University
Enrollment
35
Primary Endpoint
Crestal bone loss
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

Changes in the marginal bone level surrounding the implant are the frequently used parameters in assessing the short- and long-term success. Multiple biological and biomechanical factors have been reported to adversely affect marginal bone level. Recently, initial vertical mucosal tissue thickness has also been reported to have an impact on bone stability.The hypothesis of present study is that soft tissue thickness on implant placement has no positive impact of crestal bone remodeling.

Detailed Description

The aim of this study is to evaluate the clinical and radiographical results of submerged and nonsubmerged implants with thin (\<3 mm) and thick (\>3 mm) soft tissue over 1.5 year after implant placement. All submerged and nonsubmerged implants were randomly placed as split-mouth. Clinical periodontal parameters were recorded. Crestal bone levels were analyzed from the day of implants inserted to 1.5 year after prosthetic loading on digitally standardized radiographs. Non-parametric test were used for statistically analysis.

Registry
clinicaltrials.gov
Start Date
October 2009
End Date
November 2011
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Deniz Cengiz Özkaya

PhD, DDS

Ege University

Eligibility Criteria

Inclusion Criteria

  • being older than 18 years of age
  • generally healthy patients, no medical contraindication for implant surgery
  • missing teeth in upper jaw posterior and more than one tooth in neighbourhood area
  • no bone augmentation procedures before and during implant placement.

Exclusion Criteria

  • poor oral hygiene
  • history of periodontitis
  • alcoholism
  • taking medication which interferes soft and hard tissue healing

Outcomes

Primary Outcomes

Crestal bone loss

Time Frame: Change from baseline crestal bone level at 18th month after placement,

Crestal bone loss was measured on radiographs between baseline-18th month after placement

Secondary Outcomes

  • Modified sulcus bleeding index(Modified sulcus bleeding index was recorded at 18th month after implant placement)
  • Keratinized tissue level(Evaluation of keratinized tissue level at 18th month after placement (mm))
  • Modified plaque index(Modified plaque index was recorded at 18th month after implant placement)
  • Probing depth(Evaluation of probing depth at 18th month after placement (mm))

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