Clinical Trials Logo
  1. Home
  2. Dental Implant
  3. NCT04861662
  4. Details
NCT04861662 Clinical Trial

Effect of Keratinized Mucosa on Peri-implant Health

Dental Implant Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04861662
Other study ID # 01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 10, 2018
Est. completion date June 30, 2021

Study information
Verified date September 2021
Source Kutahya Health Sciences University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 31
Est. completion date June 30, 2021
Est. primary completion date April 9, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 85 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Free gingival graft procedure
Free gingival graft procedure applied to implants with KM<2 mm to increase the width of keratinized mucosa surrounding them

Locations
Country Name City State
Turkey Kutahya Health Sciences University Kütahya

Sponsors (1)
Lead Sponsor Collaborator
Kutahya Health Sciences University

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Marginal bone loss Change of marginal bone loss measured from periapical radiographs Baseline, 3rd month, 6th month and 1st year
Secondary Modified bleeding index Parameter showing peri-implant mucosa inflammation Baseline, 3rd month, 6th month and 1st year
Secondary Probing depth The depth of peri-implant sulcus in millimeters Baseline, 3rd month, 6th month and 1st year
Secondary Modified plaque index Parameter showing oral hygiene performance Baseline, 3rd month, 6th month and 1st year
See also
  Status Clinical Trial Phase
Enrolling by invitation NCT05053958 - Using Superimposition of Intra-Oral Scan and CBCT in Single Implant Restorations in Aesthetic Zone. N/A
Recruiting NCT04367766 - Management of the Fresh Extraction Socket in the Aesthetic Area N/A
Recruiting NCT06296459 - Radiographic Changes in the Maxillary Sinus Following Closed Sinus Augmentation N/A
Not yet recruiting NCT05988281 - Success of Implant Restorations After Immediate or Delayed Implant Placement With/Without Ridge Preservation N/A
Completed NCT04340830 - The Effect of Smoking on Dimensional Changes of Free Gingival Graft Around Dental Implants N/A
Recruiting NCT05405179 - Simultaneous Dental Implant in Free Vascularized Bone Flaps for Jaw Reconstruction N/A
Completed NCT06138392 - Long-term Study in Early Loaded Hydrophilic Surface Implants
Completed NCT04332679 - Non-resorbable Membranes Versus Titanium Meshes and Resorbable Membranes N/A
Completed NCT06127576 - Biomechanical Informational Effect of Innovative Double or Triple Dental Abutment-implant: Case-series
Recruiting NCT06059573 - The Accuracy of Dental Implant Placement Using Robotic System-assisted Surgery and Freehand Surgery N/A
Recruiting NCT06068231 - A Study of Early Loading of Implants in the Maxillary Anterior Region With Alveolar Bone Defects N/A
Active, not recruiting NCT03774888 - To Compare Different Soft Tissue Grafts at the Time of Lateral Ridge Augmentation Procedure. N/A
Completed NCT02864862 - Esthetic Outcomes Following Immediate Implant Combine With Soft Tissue Augmentation Phase 4
Completed NCT02444052 - Evaluation of Zimmer Puros® Allograft vs. Creos™ Allograft for Alveolar Ridge Preservation N/A
Not yet recruiting NCT04541641 - Clinical Evaluation of Stability of Implants Placed in Partially Edentulous Maxilla With Poor Bone Quality Via New Reverse Drilling Technique Versus Osteotome Technique. N/A
Completed NCT03888339 - Influence of Abutment Shape on Peri-implant Marginal Bone Loss N/A
Recruiting NCT06231134 - Diode Laser 940 nm Versus Electrosurgical Device During Second Stage Implant Surgery on Bone and Soft Tissue Healing N/A
Enrolling by invitation NCT04544839 - Clinical Evaluation of Two Different Attachment System N/A
Completed NCT03307083 - Operating Check List During Consultation for Dental Implant N/A
Completed NCT03018457 - Evaluation of Trabecular Microarchitecture of the Alveolar Bone by Micro-computed Tomography and of Osseointegration of Dental Implants by Resonance Frequency Analysis