Clinical trial NCT05389059: Injectable Platelet Rich Fibrin With Collagen Matrix in Treatment of Multiple Gingival Recession.
Official title: The Value of Injectable Platelet Rich Fibrin With Volume Stable Collagen Matrix in Treatment of Multiple Gingival Recession; a Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gingival Diseases
Traumatic Injury
Keywords: Gingival Recession
Collagen Matrix
Plasma rich proten
Lead sponsor: University of Baghdad
Sponsor class: OTHER
First posted: 2022-05-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Reduction in gingival recession depth on the buccal sides of type one gingival recessionRT1
timeFrame: Between the baseline preoperative measurement and follow-up at 3 months and 6 months
Secondary outcomes:
measure: Improvement in Gingival Thickness (GT)
timeFrame: Between the baseline preoperative measurement and follow-up at 3 months and 6 months
measure: Improvement in the Keratinized Tissue Height (KTH)
timeFrame: Between the baseline preoperative measurement and follow-up at 3 months and 6 months
measure: Reduction in the Recession Width (RW)
timeFrame: Between the baseline preoperative measurement and follow-up at 3 months and 6 months
measure: Reduction in Probing Pocket Depth (PPD)
timeFrame: Between the baseline preoperative measurement and follow-up at 3 months and 6 months
measure: Reduction Clinical Attachment Level (CAL)
timeFrame: Between the baseline preoperative measurement and follow-up at 3 months and 6 months
measure: Measuring Plaque-Index (PI)
timeFrame: Between the baseline preoperative measurement and follow-up at 3 months and 6 months
measure: Measuring Bleeding On Probing (BOP)
timeFrame: Between the baseline preoperative measurement and follow-up at 3 months and 6 months
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: University of Baghdad / College of Dentistry
Study officials:
affiliation: University of Baghdad
name: Basima Gh Ali, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Baghdad
name: Thair AL Hassan, PHD
role: STUDY_DIRECTOR
References: