Amnion Membrane Versus DFGG Using the Tunneling Technique in Management of Gingival Recession Defects.

Study Overview
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Brief Summary
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Treatment of gingival recession is indicated mainly for esthetic reasons and keratinized tissue augmentation (Zucchelli and Mounssif, 2015). An array of surgical techniques has been proposed by the literature to cover gingival recession defects with well-documented successful outcomes. The selection of one technique over the other depends on many factors. Some of these factors are related to the gingival recession defect itself, others are related to the anatomy of the palatal fibromucosa, or related to the patient variabilities (Zucchelli and De Sanctis, 2000). Controversy exists in the literature regarding the patient morbidity after connective tissue graft harvesting. Inconclusive postulations have been made about the post-operative patient morbidity outcomes and root coverage outcomes when comparing connective tissue graft harvesting in comparison to allograft membranes used for root coverage. The use of connective tissue graft in combination with root coverage techniques remain the gold standard for root coverage procedures. The problem with the connective tissue graft is that harvesting a graft from the palate increases morbidity, needs an extra surgical site which is more traumatic for the patient, depends on the donor tissue which could be limited, increases surgical chair-time and needs increased surgical skills (Cortellini & Pini Prato 2012). The rationale behind the use of amnion membrane is to avoid the morbidity inherent with connective tissue graft harvesting.

Official Title
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Amnion Membrane as a Soft Tissue Substitute Versus De- Epithelialized Free Gingival Graft Using the Tunneling Technique in Management of Gingival Recession Defects: A Randomized Controlled Clinical Trial.

Conditions
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Gingival Recession

Intervention / Treatment
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* Procedure: Tunneling procedure with Amnion Membrane
* Procedure: Tunneling procedure with De-epithelialized Free Gingival Graft


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18 and 60 years. Periodontally and systemically healthy. Presence of RT1 or RT2 buccal gingival recession defects ≥2 mm in depth. Full-mouth plaque and bleeding score of <15% and no probing depths >3 mm. Absence of non-carious cervical lesions (NCCLs) and non-detectable cemento-enamel junction (CEJ) at the defect sites. Exclusion Criteria: RT3 recession defects. Smokers as smoking is a contraindication for any plastic periodontal surgery (Khuller, 2009). Presence of caries lesions or restorations in the cervical area. Intake of medications which impede periodontal tissue health and healing. Medical contraindications for periodontal surgical procedures. Uncooperative patients not willing to complete the follow up period. Pregnancy and lactation.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tunneling with amnion membrane<br> | Procedure: Tunneling procedure with Amnion Membrane<br>* Root Coverage by tunneling procedure with the addition of Amnion Membrane as a soft tissue substitute<br>|
| Active Comparator: Tunneling with De-epithelialized Free Gingival Graft<br> | Procedure: Tunneling procedure with De-epithelialized Free Gingival Graft<br>* Root Coverage by tunneling procedure with the addition of De-epithelialized Free Gingival Graft<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recession depth | Measured from the CEJ to the most apical extension of the gingival margin. | 3-6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recession width | Measured horizontally between the borders of the recession. | 3-6 month | 
| Percentage of root coverage | (Preoperative vertical recession - Postoperative vertical recession/preoperative vertical recession) x 100. | 6 months | 
| Root coverage esthetic score | Based on Cairo et al., (2009) the root coverage esthetic score (RES) system evaluated five variables 6 months following surgery: gingival margin (GM), marginal tissue contour (MTC), soft tissue texture (STT), MGJ alignment, and gingival color (GC). | 6 months | 
| Gingival Thickness | Determined 2 mm apical to the gingival margin with a short needle for anesthesia and a 3 mm diameter silicon disk stop. The needle is inserted perpendicular to the mucosal surface, through the soft tissues with light pressure until a hard surface is felt. The silicon disk stop is then placed in tight contact with the soft tissue surface with the coronal border overlapping the soft tissue margin. As the needle is located in the center of the silicon disk, measurement of GT is performed 2 mm apical from the gingival margin. After careful removal of the needle, the penetration depth is measured with a caliper accurate to the nearest 0.1 mm (Paolantonio et al., 2002; da Silva et al., 2004; Joly et al., 2007). | 3-6 months | 
| Keratinized tissue width | Measured as the distance between the gingival margin and the mucogingival junction (MGJ). | 3-6 months | 
| Post-Operative Pain | Visual Analogue Scale (VAS) with numbers from 0 to 10 ('no pain' to 'worst pain imaginable') measured daily for the first week postoperatively. | 1 week | 
| Post-Surgical Patient Satisfaction | A 3-item questionnaire is asked and the patients shall use a 7- point answer scale. (Kiyak et al., 1984) | 1 week | 
| Surgical time | Total time of the surgical procedure measured using a stopwatch. | intraoperative |