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

• ClinicalTrials.gov Identifier: NCT03588052
• Recruitment Status: Unknown
• First Posted: July 17, 2018
• Last Update Posted: July 17, 2018
• Sponsor: Cairo University
• Information provided by (Responsible Party): Yasmin Medhat Sery, Cairo University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Gingival Recession	Procedure: VISTA using PRF; Procedure: VISTA using SCTG	Not Applicable

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 28 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Estimated Study Start Date: August 1, 2018
• Estimated Primary Completion Date: February 1, 2019
• Estimated Study Completion Date: February 20, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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	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; Other Name: Vestibular incision subperiosteal tunnel access technique with Platelet-rich fibrin
Active Comparator: 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	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; Other Name: Vestibular incision subperiosteal tunnel access technique with Subepithelial connective tissue graft

Outcome Measures

Primary Outcome Measures :

1. Amount of root coverage [ Time Frame: 6 months ]
   complete root coverage after surgical correction measured in millimeters by using periodontal probe

Secondary Outcome Measures :

1. Root Coverage Esthetic score a numbering score [ Time Frame: 6 months ]
   A scoring system to evaluate esthetics after surgical root coverage giving a numbering score by a periodontal probe
2. Post-Operative Pain a numerical rating scale [ Time Frame: 14 days ]
   Numerical Rating Scale (NRS) with numbers from 0 to 10 ('no pain' to 'worst pain imaginable')for the first 2 weeks postoperatively.
3. Post-Operative Swelling verbal rating scale [ Time Frame: 7 days ]
   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)
4. Post-Surgical Patient Satisfaction numerical rating scale [ Time Frame: 14 days ]
   A numerical rating scale will be used. A 3-item questionnaire is asked and the patients shall use a 7 point answer scale.
5. Clinical Attachment level gain in millimeters [ Time Frame: 6 months ]
   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. Probing depth in millimeters [ Time Frame: 6 months ]
   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.
7. Keratinized Tissue Width in millimeters [ Time Frame: 6 months ]
   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
8. Gingival Thickness in millimeters [ Time Frame: 6 months ]
   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

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 50 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Contacts

Contact: Yasmin Medhat Sery, Bachelor; (+2) 01060122275; Yasmin.sery@gmail.com

Contact: Ahmed El-Barbary, Phd; 01223153678; ahmedelbarbary102@hotmail.com

Sponsors and Collaborators

Cairo University

Investigators

• Study Director: Mona Darhous, Phd; Cairo University
• Study Chair: Ahmed El-Barbary, Phd; Cairo University
• Study Chair: Marwa Hegab, Phd; Cairo University
• Principal Investigator: Yasmin Sery, Bachelor; Cairo University

More Information

• Responsible Party: Yasmin Medhat Sery, B.Sc. in Oral and Dental Medicine, Cairo University
• ClinicalTrials.gov Identifier: NCT03588052
• Other Study ID Numbers: 4061989
• First Posted: July 17, 2018
• Last Update Posted: July 17, 2018
• Last Verified: July 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yasmin Medhat Sery, Cairo University:

Vestibular incision subperiosteal tunnel access, Subepithelial connective tissue graft, Platelets rich fibrin, Multiple gingival recessions

Additional relevant MeSH terms:

Gingival Recession; Surgical Wound; Wounds and Injuries; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy