The Effect of Injectable Platelet-Rich Fibrin in Peri-implant Soft Tissue
ConditionPeri-Implant Tissues
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKutahya Health Sciences University
About this trial
An inadequate amount of peri-implant soft tissue results in more plaque accumulation around the implants, peri-implant mucositis, marginal bone loss, mucosal recession, and/or attachment loss. In the literature, there are studies evaluating the application of injectable platelet-rich fibrin to the gingiva and oral mucosa around teeth, but injectable platelet-rich fibrin application around implants has not been encountered. This study aimed to evaluate the effect of subgingival and submucosal application of injectable platelet-rich fibrin on peri-implant soft tissue phenotype in patients with inadequate peri-implant soft tissue phenotype.The study will include 80 systemically healthy and non-smoking patients/implants older than 18 years of age with insufficient peri-implant keratinized mucosa width and mucosal thickness who applied to Kütahya University of Health Sciences, Faculty of Dentistry, Department of Periodontology. There are two study groups according to peri-implant mucosa phenotype: Thin phenotype and thick phenotype. All patients will undergo the same procedure of injectable platelet-rich fibrin application
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
be over 18 years old
The patient does not have any systemic disease
Patients who do not smoke or who smoke less than 10 cigarettes
Peri-implant keratinized mucosa width less than 2 mm
Disqualifiers
Being out of the defined age group
Any systematic contraindication for periodontal surgery
Patients who smoke more than 10 cigarettes per day
Patients with adequate peri-implant keratinized mucosa width and mucosal thickness
Trial design
Design model
Parallel
Treatments tested in this trial
Platelet rich fibrin
Procedure/SurgeryThe injectable platelet rich fibrin will be integrated into the tissue by subgingival and submucosal application to the keratinized gingiva of the implant sites with insufficient peri-implant soft tissue phenotype. Then, the prepared injectable platelet rich fibrin will be injected into the mucogingival junction apical to the keratinized gingival site. This procedure will be repeated 3 times in total, 1 time in 30 days for 3 months.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Thin phenotypeOther 1 intervention
Group B: Thick phenotypeOther 1 intervention
Trial outcomes
Primary outcomes
1
Peri-implant keratinized mucosa width
To measure peri-implant keratinized mucosa width of subgingival and submucosal injection of injectable platelet-rich fibrin in patients with inadequate peri-implant soft tissue phenotype at 1-year follow-up.
Time frame
1-year follow-up of all implants2
Peri-implant mucosa thickness
To measure peri-implant mucosa thickness of subgingival and submucosal injection of injectable platelet-rich fibrin in patients with inadequate peri-implant soft tissue phenotype at 1-year follow-up.
Time frame
1-year follow-up of all implantsSecondary outcomes
1
Pink esthetic score
To measure the effect of subgingival and submucosal injectable platelet-rich fibrin application on the pink aesthetic score by the patient and physician in patients with inadequate peri-implant soft tissue phenotype.
Time frame
1-year follow-up of all implantsSponsors and contacts
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Source ClinicalTrials.gov