Effect of Keratinized Mucosa on Peri-implant Health
Clinical and Radiographic Evaluation of the Effect of Keratinized Mucosa on Peri-implant Health
1 other identifier
interventional
31
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 10, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 9, 2021
CompletedFirst Submitted
Initial submission to the registry
April 20, 2021
CompletedFirst Posted
Study publicly available on registry
April 27, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2021
CompletedSeptember 5, 2021
September 1, 2021
2.5 years
April 20, 2021
September 3, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Marginal bone loss
Change of marginal bone loss measured from periapical radiographs
Baseline, 3rd month, 6th month and 1st year
Secondary Outcomes (3)
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 Arms (3)
Keratinized Mucosa Sufficient (KMS)
NO INTERVENTIONImplants exhibiting the width of keratinized mucosa (KM) ≥2 mm at the midbuccal aspect
Keratinized Mucosa Deficient (KMD)
NO INTERVENTIONImplants exhibiting KM\<2 mm at the midbuccal aspect
Free Gingival Graft (FGG)
EXPERIMENTALImplants with KM\<2 mm initially and having surgically increased keratinized mucosa with free gingival graft after prothesis delivery
Interventions
Free gingival graft procedure applied to implants with KM\<2 mm to increase the width of keratinized mucosa surrounding them
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kutahya Health Sciences University
Kütahya, Turkey (Türkiye)
Study Officials
- PRINCIPAL INVESTIGATOR
Melike Başaran
melike_basaran@ksbu.edu.tr
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Asst. Prof. Ezgi GÜRBÜZ, DDS
Study Record Dates
First Submitted
April 20, 2021
First Posted
April 27, 2021
Study Start
October 10, 2018
Primary Completion
April 9, 2021
Study Completion
June 30, 2021
Last Updated
September 5, 2021
Record last verified: 2021-09