Effect of Keratinized Mucosa on Peri-implant Health
September 3, 2021 updated by: Ezgi Gürbüz, Kutahya Health Sciences University
Clinical and Radiographic Evaluation of the Effect of Keratinized Mucosa on Peri-implant Health
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
31
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
-
-
-
Kütahya, Turkey
- Kutahya Health Sciences University
-
-
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
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
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: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Keratinized Mucosa Sufficient (KMS)
Implants exhibiting the width of keratinized mucosa (KM) ≥2 mm at the midbuccal aspect
|
|
|
No Intervention: Keratinized Mucosa Deficient (KMD)
Implants exhibiting KM<2 mm at the midbuccal aspect
|
|
|
Experimental: Free Gingival Graft (FGG)
Implants with KM<2 mm initially and having surgically increased keratinized mucosa with free gingival graft after prothesis delivery
|
Free gingival graft procedure applied to implants with KM<2 mm to increase the width of keratinized mucosa surrounding them
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Marginal bone loss
Time Frame: Baseline, 3rd month, 6th month and 1st year
|
Change of marginal bone loss measured from periapical radiographs
|
Baseline, 3rd month, 6th month and 1st year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Modified bleeding index
Time Frame: Baseline, 3rd month, 6th month and 1st year
|
Parameter showing peri-implant mucosa inflammation
|
Baseline, 3rd month, 6th month and 1st year
|
|
Probing depth
Time Frame: Baseline, 3rd month, 6th month and 1st year
|
The depth of peri-implant sulcus in millimeters
|
Baseline, 3rd month, 6th month and 1st year
|
|
Modified plaque index
Time Frame: Baseline, 3rd month, 6th month and 1st year
|
Parameter showing oral hygiene performance
|
Baseline, 3rd month, 6th month and 1st year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Melike Başaran, melike_basaran@ksbu.edu.tr
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)
October 10, 2018
Primary Completion (Actual)
April 9, 2021
Study Completion (Actual)
June 30, 2021
Study Registration Dates
First Submitted
April 20, 2021
First Submitted That Met QC Criteria
April 24, 2021
First Posted (Actual)
April 27, 2021
Study Record Updates
Last Update Posted (Actual)
September 5, 2021
Last Update Submitted That Met QC Criteria
September 3, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- 01 (Leona M. and Harry B. Helmsley Charitable Trust)
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.