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Randomized split mouth clinical trials study focused on comparing the efficacy of C-PRF/ Hyaluronic acid combination versus C-PRF injection alone in subjects with thin gingival phenotype.
Gingival phenotype is an important periodontal parameter focused on the gingival thickness and keratinized tissue width.
The gingival phenotype is either thin or thick. Thick gingival phenotype resist infections and periodontal disease more than the thin gingival phenotype.
Multiple surgical approaches to modify the ginigval phenotype from thin to thick has been done in clinical dentistry.
While surgical approach is invasive, recent periodontal trends tends to go with non-invasive ways to treat periodontal conditions. It involves PRF injections as an example.
In this study we're utilizing the PRF combination with Hyaluronic acid and inject this combination to increase the gingival thickness and keratinized tissue width.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| C-PRF only | Active Comparator | In this group, the participants gingival tissue would be injected with C-PRF only, at a fixed point 1.5mm bellow the free gingival margin. (Using the prefabricated stent, the injection would be repeatable each session). |
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| C-PRF/ Hyaluronic acid combination | Experimental | In this group, the participants gingival tissue would be injected with C-PRF/ Hyaluronic acid combination at a fixed point 1.5mm bellow the free gingival margin. (Using the prefabricated stent, the injection would be repeatable each session). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| C-PRF and Hyaluronic Acid | Other | A mixed preparation consisting of 0.5 mL of Concentrated Platelet-Rich Fibrin (C-PRF) and 0.5 mL of 1.6% cross-linked hyaluronic acid, 0.2% natural Hyaluronic Acid. The mixture is administered via direct subepithelial injection at the mucogingival junction of the target teeth using a 30-gauge needle. 3 injections sessions with 10 days intervals and baseline, 3 months and 6 months follow up visits. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Gingival Thickness & Keratinized Tissue Width at baseline and at 6 months after the injection of C-PRF/ Hyaluronic acid | Using Trans-ginval probing method to measure the gingival thickness and using Periodontal probe with 1 mm markings to measure the keratinzed tissue width, we measure the difference between the baseline and 6 month after the injection of C-PRF/ Hyaluronic acid and compare the readings with the other side that would be injected with C-PRF alone. (To make the assessments repeatable, we will fabricated a stent for each participant. Each stent has a specific hole to measure the gingival thickness through it in order to make the readings as accurate as possible and all the measurements will be in mm scale). | baseline - 6 months follow up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sajjad Ahmed Shakir, M.Sc. | Contact | 07730642935 | +964 | sajjad.shakir1959@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Sajjad Ahmed Shakir, M.Sc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Al-mustansiriyah university | Baghdad | Alresafa | 10011 | Iraq |
the study will be published and shared for other researchers in medical journals.
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| ID | Term |
|---|---|
| D006820 | Hyaluronic Acid |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| C-PRF | Other | 1 mL of Concentrated Platelet-Rich Fibrin (C-PRF) is administered via direct subepithelial injection at the mucogingival junction of the target teeth using a 30-gauge needle. 3 injections sessions with 10 days intervals and baseline, 3 months and 6 months follow up visits. |
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