Evaluation of Esthetic Root Coverage Using Platelet-Rich Fibrin Versus Subepithelial Connective Tissue Graft With Vestibular Incision Subperiosteal Tunnel Access in Multiple Gingival Recessions

Gingival Recession Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03588052
• Other study ID #: 4061989
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: February 20, 2019

Study information

• Verified date: July 2018
• Source: Cairo University
• Contact: Yasmin Medhat Sery, Bachelor
• Phone: (+2) 01060122275
• Email: Yasmin.sery[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 28
• Est. completion date: February 20, 2019
• Est. primary completion date: February 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

Inclusion Criteria:

1. Multiple adjacent maxillary or mandibular gingival recessions Miller class ? 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

Related Conditions & MeSH terms

• Gingival Recession
• Surgical Wound

Intervention

Procedure:
• VISTA using PRF
Vertical vestibular access incision will be done through the periosteum to elevate a subperiosteal tunnel, exposing the facial osseous plate. The tunnel will be extended beyond mucogingival junction and at least one or two teeth beyond the teeth indicated for root coverage to mobilize gingival margins and allow for low-tension coronal repositioning of the gingiva. Freshly prepared platelet-rich fibrin will be secured in the tunnel to cover the root dehiscence, coronal advancement of gingival margin and suturing to the facial aspect of each tooth to avoid apical relapse of the gingival margin during the initial phase of healing. The vertical incision will be then approximated and sutured
• VISTA using SCTG
Vertical vestibular access incision will be done through the periosteum to elevate a subperiosteal tunnel, exposing the facial osseous plate. The tunnel will be extended beyond mucogingival junction and at least one or two teeth beyond the teeth indicated for root coverage to mobilize gingival margins and allow for low-tension coronal repositioning of the gingiva. Subepithelial connective tissue graft will be secured in the tunnel to cover the root dehiscence, coronal advancement of gingival margin and suturing to the facial aspect of each tooth to avoid apical relapse of the gingival margin during the initial phase of healing. The vertical incision will be then approximated and sutured

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of root coverage	complete root coverage after surgical correction measured in millimeters by using periodontal probe	6 months
Secondary	Root Coverage Esthetic score a numbering score	A scoring system to evaluate esthetics after surgical root coverage giving a numbering score by a periodontal probe	6 months
Secondary	Post-Operative Pain a numerical rating scale	Numerical Rating Scale (NRS) with numbers from 0 to 10 ('no pain' to 'worst pain imaginable')for the first 2 weeks postoperatively.	14 days
Secondary	Post-Operative Swelling verbal rating scale	Verbal Rating Scale (VRS); absent(no swelling), slight (intraoral swelling at the operated area), moderate (moderate intraoral swelling at the operated area) and intense (intensive extraoral swelling extending beyond the operated area)	7 days
Secondary	Post-Surgical Patient Satisfaction numerical rating scale	A numerical rating scale will be used. A 3-item questionnaire is asked and the patients shall use a 7 point answer scale.	14 days
Secondary	Clinical Attachment level gain in millimeters	the clinical attachment level is the measurement of the position of the soft tissue in relation to the cemento-enamel junction (CEJ). Two measurements are used to calculate the CAL: the probing depth and the distance from the gingival margin to the CEJ. measured using a periodontal probe in millimeters.	6 months
Secondary	Probing depth in millimeters	It is measuring the distance from the gingival margin to the base of the pocket using periodontal probe. The probe will be inserted parallel to the long axis of the tooth using light force.	6 months
Secondary	Keratinized Tissue Width in millimeters	It is measured from the free gingival margin to the mucogingival junction (MGJ). By using the periodontal probe, MGJ will be identified using the roll technique	6 months
Secondary	Gingival Thickness in millimeters	It is measured by penetrating the gingiva mid-buccally in the attached gingiva, half way between mucogingival junction and free gingival groove to measure the gingival thickness	6 months