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

NCT ID: NCT03588052

Last Updated: 2018-07-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-01
• Study Completion Date: 2019-02-20

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

Conditions

Gingival Recession

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

VISTA using PRF

Vestibular incision subperiosteal tunnel access combined with Platelets-Rich Fibrin

An intravenous blood will be drawn from the patient in a glass-coated plastic tubes, centrifuged at 3000 rpm for 10-12 min. A Platelets rich fibrin membrane will then be obtained

Group Type: EXPERIMENTAL

VISTA using PRF

Intervention Type: PROCEDURE

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

vestibular incision subperiosteal tunnel access combined with subepithelial connective tissue graft

Subepithelial connective tissue graft will be harvested from the palate, secured in the tunnel to cover the root dehiscence then sutured

Group Type: ACTIVE_COMPARATOR

VISTA using SCTG

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: PROCEDURE

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

Intervention Type: PROCEDURE

Other Intervention Names

Vestibular incision subperiosteal tunnel access technique with Platelet-rich fibrin; Vestibular incision subperiosteal tunnel access technique with Subepithelial connective tissue graft

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Yasmin Medhat Sery

B.Sc. in Oral and Dental Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mona Darhous, Phd

Role: STUDY_DIRECTOR

Cairo University

Ahmed El-Barbary, Phd

Role: STUDY_CHAIR

Cairo University

Marwa Hegab, Phd

Role: STUDY_CHAIR

Cairo University

Yasmin Sery, Bachelor

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Central Contacts

Yasmin Medhat Sery, Bachelor

Role: CONTACT

Yasmin.sery@gmail.com

(+2) 01060122275

Ahmed El-Barbary, Phd

Role: CONTACT

ahmedelbarbary102@hotmail.com

01223153678

Other Identifiers

4061989

Identifier Type: -

Identifier Source: org_study_id