Gingival Diseases, Traumatic Injury
Conditions
Keywords
Gingival Recession, Collagen Matrix, Plasma rich proten
Brief summary
This study is proposing the use of i-PRF clot as a scaffold for the XCM in order to obtain a novel biomaterial, incorporating active growth factors and collagen matrix in a single framework, based on the potential effect of i-PRF to enhance fibroblast activity and angiogenesis stimulation for treatment of multiple gingival recession.
Interventions
PROCEDURECAF+CM
Periodontal surgery including CAF+CM application
PROCEDUREI-PRF
Periodontal surgery including CAF+CM application with i-PRF
Sponsors
University of Baghdad
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Presence of at least two localized gingival recessions on either sides of the maxilla and/or mandible excluding molar region. * The cemento-enamel junction (CEJ) is visible in the teeth for root coverage procedures. * All recessions are type 1recession RT1 (cairo et al,2011) which correspond to Miller I&II gingival recession * All patients must demonstrate adequate plaque control with a fullmouth plaque score less than 20% and with . * All patients at least 18 years of age and of both genders.
Exclusion criteria
* Smoker Patients . * Patients with diabetes. * Patients with a history of malignancy, radiotherapy, or chemotherapy for malignancy. * pregnant or nursing women. * Patients taking medications or having treatments with an effect on mucosal healing in general (e.g. steroids, large doses of antiinflammatory drugs). * Patients with a disease affecting connective tissue metabolism. * Patients allergic to collagen.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in gingival recession depth on the buccal sides of type one gingival recessionRT1 | Between the baseline preoperative measurement and follow-up at 3 months and 6 months | The primary outcome of the study is the reduction in gingival recession depth on the buccal sides of RT1 gingival recession, between the baseline preoperative measurement and follow-up at 3 months and 6 months. The Recession Depth (RD) is Measured in millimeter (mm) from CEJ (Cemento-Enamel-Junction) to the gingival margin using UNC-15 probe. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measuring Bleeding On Probing (BOP) | Between the baseline preoperative measurement and follow-up at 3 months and 6 months | Bleeding On Probing (BOP) is measured as a percentage of sites with bleeding on probing using a manual periodontal probe. |
| Improvement in Gingival Thickness (GT) | Between the baseline preoperative measurement and follow-up at 3 months and 6 months | Gingival Thickness (GT) is determined at 1.5 mm apical to the gingival margin using a caliper (endodontic reamer#20) rounded to the nearest 0.1mm. |
| Improvement in the Keratinized Tissue Height (KTH) | Between the baseline preoperative measurement and follow-up at 3 months and 6 months | Keratinized Tissue Height (KTH) is measured in millimeters (mm) taken at the mid buccal aspect of the involved teeth from the gingival margin to the muco-gingival junction, by a manual periodontal probe (UNC-15 probe,Hu-Friedy,Chicago,USA). |
| Measuring Plaque-Index (PI) | Between the baseline preoperative measurement and follow-up at 3 months and 6 months | Plaque-Index (PI) is measured as a percentage of the presence of Plaque on four surfaces of the teeth using a manual periodontal probe. |
| Reduction in Probing Pocket Depth (PPD) | Between the baseline preoperative measurement and follow-up at 3 months and 6 months | Probing Pocket Depth (PPD) is measured in millimeter (mm) from the gingival margin to the apical extend of the probe. |
| Reduction Clinical Attachment Level (CAL) | Between the baseline preoperative measurement and follow-up at 3 months and 6 months | Clinical Attachment Level (CAL) is measured in millimeter (mm) from the CEJ to the apical extend of the probe. |
| Reduction in the Recession Width (RW) | Between the baseline preoperative measurement and follow-up at 3 months and 6 months | Recession Width (RW) is measured in millimeter (mm) at the Cement-Enamel Junction (CEJ) using UNC-15 probe. |
Countries
Iraq
Outcome results
None listed