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
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Dental Implant
• Free Gingival Graft
• Keratinized Mucosa

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