RhEGF Incorporated in An Absorbable Collagen Membrane for The Management Of Gingival Recession Defects

Study Overview
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Brief Summary
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A sulcular incision will be made through each recession area and the tissues will be gradually undermined including the base of the interdental papilla. At the recession sites rhEGF incorporated absorbable collagen membrane will be gradually manipulated into the pouch through the tunnel till it covers the recession sites and will be stabilized with sutures.

Detailed Description
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IN TEST SITE : Local anesthesia will be administered and Vertical incisions will be given at interdental papillae away from recession defect site and a pouch will be created. A sulcular incision will be made through each recession area and the tissues will be gradually undermined including the base of the interdental papilla. At the recession sites rhEGF incorporated absorbable collagen membrane will be gradually manipulated into the pouch through the tunnel till it covers the recession sites and will be stabilized with sutures. IN CONTROL SITE: Same procedure will be done as the test site but plain collagen membrane will be gradually manipulated into the pouch through the tunnel till it covers the recession sites and will be stabilized with sutures.

Official Title
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Efficacy of Recombinant Human Epidermal Growth Factor (RhEGF) Incorporated in An Absorbable Collagen Membrane for The Management of Gingival Recession Defects

Conditions
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Periodontitis

Intervention / Treatment
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* Drug: RhEGF
* Drug: Plain Collagen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Systemically healthy male and female patients of age 20-55 yrs with Millers class I or class II gingival recession are included in the study. Exclusion Criteria: Patients who are medically compromised and Subjects who underwent radiotherapy or chemotherapy and who are Smokers are excluded from the study

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EGF impregnated in collagen membrane<br>EGF impregnated in collagen membrane is placed in gingival recession defects | Drug: RhEGF<br>* The EGF impregnated membrane will be placed upon the recession site and will be stabilized by suturing it to the lingual papillae using 4-0 absorbable sutures. The flap will be coronally advanced as far as possible to cover the membrane and will be sutured to the buccal interdental papillae with 4-0 absorbable sutures (Trulenetm, Healthium Medtech Pvt Ltd, Bangalore, India). Standard recall and maintenance regimen will be followed and subjects will be encouraged to report to the department on a monthly basis.<br>* Other names: EGF+Collagen;|
| Active Comparator: plain collagen membrane<br>plain collagen membrane is placed in gingival recession defects | Drug: Plain Collagen<br>* A collagen membrane without FGF-2 will be used.<br>* Other names: Control group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recession depth (RD) | Recession depth (RD) - measured from cementoenamel junction to most apical extension of gingival margin. | Base line to 6months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Width of keratinized gingiva (KGW) | Width of keratinized gingiva (KGW) - distance between gingival margin and mucogingival junction will be evaluated. | Base line to 6months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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epidermal growth factor, gingival recession