Clinical trial NCT03588052: Evaluation of Esthetic Root Coverage Using Platelet-Rich Fibrin Versus Subepithelial Connective Tissue Graft With Vestibular Incision Subperiosteal Tunnel Access in Multiple Gingival Recessions
Official title: Evaluation of Esthetic Root Coverage Using Platelet-Rich Fibrin Versus Subepithelial Connective Tissue Graft With Vestibular Incision Subperiosteal Tunnel Access Technique in Patients With Multiple Gingival Recessions: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gingival Recession
Keywords: Vestibular incision subperiosteal tunnel access, Subepithelial connective tissue graft, Platelets rich fibrin, Multiple gingival recessions
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-07-17
Enrollment: 28
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with gingival recession, complain of excessive tooth length that affects their appearance during smiling or functioning. The main goal of plastic periodontal surgeries is to restore patient's esthetic demands with the regeneration of gingival and periodontal tissues.

Although SCTG is considered a gold standard, it has its own limitations like patient morbidity and graft availability. Consequently, PRF has been introduced in an attempt to overcome the drawbacks of SCTG and achieve optimum results in root coverage.

The minimally invasive VISTA technique allows better access with coronal positioning and stabilization of gingival margin to achieve complete root coverage. In addition to platelets-rich fibrin that gives a predictable and reproducible result in restoring the amount of keratinized tissue, root coverage and better esthetic outcome. The use Vestibular incision subperiosteal tunneling access (VISTA) with platelet-rich fibrin will be used to achieve complete root coverage.

Detailed description: Gingival recession is defined as apical displacement of gingival margin beyond the cementoenamel junction leading to the exposure of root surface. There are various etiologic factors for gingival recession like trauma, infection and other anatomical factors.

Nowadays, periodontal plastic surgeries for treatment of gingival recession have become an important array due to increase in patient's esthetic demands and other conditions such as dentin hypersensitivity, root caries or abrasion, keratinized tissue augmentation and gingival margin discrepancy.

Subepithelial connective tissue grafts (SCTG) are considered the gold standard to obtain maximum root coverage due to its characteristics of quick keratinization and periodontal connective tissue adherence, in addition to its good blood supply to the graft and high degree of gingival color match and esthetics. However, the application of this technique is limited by the thickness of the donor tissue, anatomical factors, limited quantity compromising their use in multiple recession, tissue morbidity, and technique sensitive with postoperative pain, bleeding and swelling.

Accordingly, alternative membranes and new biomaterials have been introduced to overcome the limitations of SCTG.

Platelet rich fibrin (PRF) was introduced; a second generation platelet concentrate. PRF contains growth factors that play an essential role in soft and hard tissue regeneration; they promote fibroblastic proliferation, increase tissue vascularization, enhance soft tissue healing potential and accelerate bone regeneration. These growth factors include (PDGFs), epidermal growth factor (EGF), transforming growth factor beta (TGF-β), vascular endothelial growth factor (VEGF).

Vestibular incision subperiosteal tunnel access (VISTA), a novel minimal invasive technique for achieving root coverage that overcome the limitation of the previous intrasulcular tunneling techniques.

Hence this study will performed to evaluate the use of PRF in conjunction with VISTA technique in management of patients with multiple gingival recessions

Eligibility criteria: Inclusion Criteria:

1. Multiple adjacent maxillary or mandibular gingival recessions Miller class І or II
2. Good oral hygiene with full mouth plaque score (FMPS) ≤ 20% (O'Leary et al. 1972)

Exclusion Criteria:

1. Any systemic condition that may contraindicate periodontal surgery
2. Individuals taking medications that interfere with periodontal tissue health or healing
3. Previous periodontal plastic surgery in the selected sites for at least 6 months before the study
4. Pregnancy or lactating women
5. Former or current smokers
6. Active periodontal disease
7. Non-compliant patients.
8. Any restorations found in the selected sites

Primary outcomes:
measure: Amount of root coverage
timeFrame: 6 months
Secondary outcomes:
measure: Root Coverage Esthetic score a numbering score
timeFrame: 6 months
measure: Post-Operative Pain a numerical rating scale
timeFrame: 14 days
measure: Post-Operative Swelling verbal rating scale
timeFrame: 7 days
measure: Post-Surgical Patient Satisfaction numerical rating scale
timeFrame: 14 days
measure: Clinical Attachment level gain in millimeters
timeFrame: 6 months
measure: Probing depth in millimeters
timeFrame: 6 months
measure: Keratinized Tissue Width in millimeters
timeFrame: 6 months
measure: Gingival Thickness in millimeters
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Mona Darhous, Phd
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Ahmed El-Barbary, Phd
role: STUDY_CHAIR
affiliation: Cairo University
name: Marwa Hegab, Phd
role: STUDY_CHAIR
affiliation: Cairo University
name: Yasmin Sery, Bachelor
role: PRINCIPAL_INVESTIGATOR
References: