Clinical trial NCT04861662: Effect of Keratinized Mucosa on Peri-implant Health
Official title: Clinical and Radiographic Evaluation of the Effect of Keratinized Mucosa on Peri-implant Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Keratinized Mucosa
Dental Implant
Free Gingival Graft
Lead sponsor: Kutahya Health Sciences University
Sponsor class: OTHER
First posted: 2021-04-27
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Marginal bone loss
timeFrame: Baseline, 3rd month, 6th month and 1st year
Secondary outcomes:
measure: Modified bleeding index
timeFrame: Baseline, 3rd month, 6th month and 1st year
measure: Probing depth
timeFrame: Baseline, 3rd month, 6th month and 1st year
measure: Modified plaque index
timeFrame: Baseline, 3rd month, 6th month and 1st year
Other outcomes:
Locations:
city: Kütahya
country: Turkey
facility: Kutahya Health Sciences University
Study officials:
affiliation: melike_basaran@ksbu.edu.tr
name: Melike Başaran
role: PRINCIPAL_INVESTIGATOR
References: