Efficacy of C-PRF vs i-PRF in Thin Gingival Biotype Subjects

Study Overview
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Brief Summary
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Randomized split mouth clinical trials study focused on comparing the efficacy of i-prf versus c-prf injections on gingival thickness and keratinized tissue width in subjects with thin gingival biotype.

Detailed Description
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Randomized split mouth clinical trials study focused on comparing the efficacy of i-prf versus c-prf injections on gingival thickness and keratinized tissue width in subjects with thin gingival biotype. Gingival biotype is an important clinical parameter that plays an important role in determining the gingival health in the future and the possibility of developing gingival recession or other gingival unhealthy condition that is related to thin gingival biotype. Gingival biotype is consist of gingival thickness and keratinized tissue width, and its either thin or thick, and the later is more favourable to withstand the developing of gingival diseases and unhealthy condition, with this study we compare the effect of i-PRF injection which is approved in many previous clinical trials that it affects the gingival biotype and increases gingival thickness and the keratinized tissue width, and compare it to newly developed PRF generation (C-PRF) which is Concentrated Platelet Rich Fibrin.

Official Title
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Efficacy of C-PRF Versus i-PRF on Gingival Thickness & Keratinized Tissue Width in Subjects With Thin Gingival Biotype: ( Split Mouth Controlled Clinical Trials)

Conditions
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Thin Gingival Biotype

Intervention / Treatment
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* Other: Platelets Rich Fibrin (i-PRF / C-PRF)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years and no systemic disease or pregnancy. Non-smoker. Subjects with clinically healthy intact periodontium; bleeding on probing (BOP)<10%, probing pocket depth (PPD)≤3mm, intact periodontium (no probing attachment loss). (Chapple et al., 2018). Four non-adjacent sites of anterior region with thin gingival biotype (GT ≤ 1mm). (Patrick H. et al., 2018). No malocclusion, crowding, filling, missing or supernumerary mandibular anterior teeth. No blood-borne conditions. Any symptoms of recent acute illness e.g., COVID-19. Exclusion Criteria Active orthodontic treatment. Previous periodontal surgery. Use of blood thinners. Use of any drugs that might lead to gingival enlargement. Attrition. Gingival Recession. Thick gingival biotype.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: i-PRF<br>The sides of the mouth that will be injected with injectable-Platelets Rich Fibrin | Other: Platelets Rich Fibrin (i-PRF / C-PRF)<br>* one site of the mouth will be injected with i-PRF and the other site will be injected with C-PRF<br>|
| Experimental: C-PRF<br>The sides of the mouth that will be injected with Concentrated-Platelets Rich Fibrin | Other: Platelets Rich Fibrin (i-PRF / C-PRF)<br>* one site of the mouth will be injected with i-PRF and the other site will be injected with C-PRF<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measure the mean differences gain of GT&KTW | the increase in gingival thickness and keratinized tissue width after the injection of prf concentrates. | baseline and 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measure the mean difference gain of GT&KTW | the increase in gingival thickness and keratinized tissue width after the injection of prf concentrates. | baseline and 1 month |