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Clinical Trials/NCT04861662
NCT04861662
Completed
Not Applicable

Clinical and Radiographic Evaluation of the Effect of Keratinized Mucosa on Peri-implant Health

Kutahya Health Sciences University1 site in 1 country31 target enrollmentOctober 10, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Keratinized Mucosa
Sponsor
Kutahya Health Sciences University
Enrollment
31
Locations
1
Primary Endpoint
Marginal bone loss
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

The aim of this clinical study is to evaluate the significance of keratinized mucosa and to investigate the influence of free gingival graft procedure on peri-implant health status in patients after prothesis delivery.

Detailed Description

The study will be conducted in Faculty of Dentistry, Kutahya Health Sciences University . The patients who applied to the Department of Periodontology, received dental implant treatment, and required routine follow-up for the maintenance of peri-implant health will be included. Clinical and radiographic examinations will be performed at baseline (prothesis delivery) and at the end of the 3rd, 6th month, 1st year following the prosthetic loading. During clinical examination probing depth (PD), modified plaque index (mPI) and modified bleeding index (mBI) measurements will be evaluated with the Williams periodontal probe. These measurements will be taken at four points of the implant (mid-buccal, mesio-buccal, disto-buccal and mid-lingual) and these four measurements will be averaged for each implant. In addition, the amount of keratinized mucosa (KM) in the implant sites will be evaluated by measuring the mucosal margin and mucogingival junction on the vestibular surface with the same probe. After clinical examination, a periapical radiograph will be taken using a parallel technique to determine marginal bone loss surrounding the implant. The distance between the implant neck and the most coronal part of the alveolar crest will be measured on the mesial and distal surfaces for each implant on the obtained radiographs and the average of the two measurements will be taken. The parameters checked during clinical and radiographic examination will be compared between patients with or without keratinized mucosa and whose keratinized mucosa has been increased by free gingival graft.

Registry
clinicaltrials.gov
Start Date
October 10, 2018
End Date
June 30, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Kutahya Health Sciences University
Responsible Party
Principal Investigator
Principal Investigator

Ezgi Gürbüz

Asst. Prof. Ezgi GÜRBÜZ, DDS

Kutahya Health Sciences University

Eligibility Criteria

Inclusion Criteria

  • Being over the age of 18
  • Having dental implant treatment and prosthetic restoration
  • Not having received bone augmentation treatment at the implant site
  • To comply with maintenance controls after dental implant treatment

Exclusion Criteria

  • Pregnancy
  • Having used systemic antibiotics within 6 weeks prior to the start of the study
  • Having a disease that affects bone and soft tissue metabolism, such as hyperthyroidism, hyperparathyroidism, and uncontrolled diabetes mellitus
  • Using drugs that cause immunosuppression
  • Using a medicine that affects bone metabolism, such as a bisphosphonate

Outcomes

Primary Outcomes

Marginal bone loss

Time Frame: Baseline, 3rd month, 6th month and 1st year

Change of marginal bone loss measured from periapical radiographs

Secondary Outcomes

  • Modified bleeding index(Baseline, 3rd month, 6th month and 1st year)
  • Probing depth(Baseline, 3rd month, 6th month and 1st year)
  • Modified plaque index(Baseline, 3rd month, 6th month and 1st year)

Study Sites (1)

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