Periodontal Pockets Clinical Trial
Official title:
Clinical Effectiveness of a Topical Subgingival Application of Injectable Platelet-rich Fibrin as Adjunctive Therapy to Scaling and Root Planing. A Double-blind Split Mouth Randomized Prospective Comparative Controlled Trial
| Verified date | April 2024 |
| Source | Syrian Private University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Clinical evaluation of local administration of injectable PRF (injectable platelet-rich fibrin) in periodontal pockets as adjunctive therapy to scaling and root planing. 15 periodontal patients will receive a through traditional mechanical treatment (scaling and root planing). Each patient will receive subgingival i-PRF injected in half mouth and the opposite side will be injected with saline, immediately after the deep scaling session.
| Status | Completed |
| Enrollment | 15 |
| Est. completion date | December 30, 2019 |
| Est. primary completion date | September 30, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 70 Years |
| Eligibility | Inclusion Criteria: - Patients are in general good health. - Patients are from both gender and are adult. - A sign informed consent from participation and permission to use obtained data for research purposes. - They have not taken medication known to interfere with periodontal tissue health or healing in the preceding 6 months. - Presence of bilateral periodontal pockets (=5 mm) on the minimum of 2 teeth in each side. Exclusion Criteria: - Patients less than 18 years' old - Immunosuppressive systemic diseases (like cancer, AIDS, diabetes…) - clotting and Hematological disorders - Medications influence on the gingival and periodontal tissues (like calcium channel blockers, or Long-term steroid use - The teeth with poor bad filling and poorly fitted restorations |
| Country | Name | City | State |
|---|---|---|---|
| Syrian Arab Republic | Syrian Private University | Damascus |
| Lead Sponsor | Collaborator |
|---|---|
| Syrian Private University |
Syrian Arab Republic,
Kour P, Pudakalkatti PS, Vas AM, Das S, Padmanabhan S. Comparative Evaluation of Antimicrobial Efficacy of Platelet-rich Plasma, Platelet-rich Fibrin, and Injectable Platelet-rich Fibrin on the Standard Strains of Porphyromonas gingivalis and Aggregatibacter actinomycetemcomitans. Contemp Clin Dent. 2018 Sep;9(Suppl 2):S325-S330. doi: 10.4103/ccd.ccd_367_18. — View Citation
Miron RJ, Fujioka-Kobayashi M, Hernandez M, Kandalam U, Zhang Y, Ghanaati S, Choukroun J. Injectable platelet rich fibrin (i-PRF): opportunities in regenerative dentistry? Clin Oral Investig. 2017 Nov;21(8):2619-2627. doi: 10.1007/s00784-017-2063-9. Epub 2017 Feb 2. — View Citation
Varela HA, Souza JCM, Nascimento RM, Araujo RF Jr, Vasconcelos RC, Cavalcante RS, Guedes PM, Araujo AA. Injectable platelet rich fibrin: cell content, morphological, and protein characterization. Clin Oral Investig. 2019 Mar;23(3):1309-1318. doi: 10.1007/s00784-018-2555-2. Epub 2018 Jul 12. — View Citation
Wang X, Zhang Y, Choukroun J, Ghanaati S, Miron RJ. Behavior of Gingival Fibroblasts on Titanium Implant Surfaces in Combination with either Injectable-PRF or PRP. Int J Mol Sci. 2017 Feb 4;18(2):331. doi: 10.3390/ijms18020331. — View Citation
Wang X, Zhang Y, Choukroun J, Ghanaati S, Miron RJ. Effects of an injectable platelet-rich fibrin on osteoblast behavior and bone tissue formation in comparison to platelet-rich plasma. Platelets. 2018 Jan;29(1):48-55. doi: 10.1080/09537104.2017.1293807. Epub 2017 Mar 29. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Clinical attachment level (CAL) | measure as the change in distance from the cementoenamel junction to the bottom of the gingival sulcus by using a periodontal probe (UNC 15 "University of North Carolina") | baseline, 2 months | |
| Primary | Probing pocket depth (PD) | measure as the change in distance from the gingival margin GM to the bottom of the gingival sulcus by using a periodontal probe (UNC 15 "University of North Carolina") | baseline, 2 months | |
| Secondary | full mouth Plaque Index Quigely Hein Index (modified by Turesky et al, 1970) | 0 No plaque
Separate flecks of plaque at the cervical margin of the tooth A thin continuos band of plaque (up to one mm) at the cervical margin of the tooth A band of plaque wider than one mm but covering less than one-third of the crown of the tooth Plaque covering at least one-third but less than two-thirds of the crown of the tooth Plaque covering two-thirds or more of the crown of the tooth labial/ buccal and lingual surfaces are assessed after using disclosing solution. An index for the entire mouth is determined by dividing the total score by the number surfaces examined. |
baseline, 2 months | |
| Secondary | Modified Gingival Index (Trombelli et al. 2004) | 0 = Normal gingiva;
= Mild inflammation - slight change in color and slight edema; = Moderate inflammation - redness, edema and glazing; = Severe inflammation - marked redness and edema, ulceration with tendency to spontaneous bleeding. will be evaluated visually |
baseline, 2 months | |
| Secondary | Bleeding on probing (BOP) | All six sites of all teeth are assessed with regard to whether probing elicits bleeding (+) or not (-). The severity of gingivitis is expressed as a percentage.
- no bleeding upon probing (not recorded) + bleeding upon probing Calculation: BOP= Number of bleeding sites x100/ Number of sites evaluated will be evaluated visually and used a UNC-15 mm "University of North Carolina" periodontal probe |
baseline, 2 months |