Al-mustansiriyah university
Baghdad, Alresafa, 10011, Iraq
NCT Number: NCT07682259
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.
Trial opening soon.
Get Notified20 year–40 year
All sexes
Interventional
Not applicable
Baghdad, Alresafa, 10011, Iraq
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: baseline - 6 months follow up
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).
Contact information is provided by the study sponsor or research team.
Sajjad Ahmed Shakir
Other
Gingival Phenotype Modification Using Super-putty C-PRF/Hyaluronic Acid Combination Versus C-PRF Alone in Subjects With Thin Gingival Phenotype: Randomized Clinical Trials
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