Clinical Evaluation of Platelet Rich Fibrin Versus Subepithelial Connective Tissue Graft for Soft Tissue Augmentation

Clinical Evaluation of Platelet Rich Fibrin Versus Subepithelial Connective Tissue Graft for Soft Tissue Augmentation Around Implant in the Aesthetic Zone: A Randomized Control Clinical Trial

Soft tissue biotype is a critical factor for success of implant in the esthetic zone . Different soft tissue augmentation techniques have been employed to increase soft tissue thickness such as: autogenous grafts, allografts, xenografts and living cellular construct (LCC). Studies showed that, allografts and xenografts were inferior when compared with autogenous graft . However, few studies were conducted to evaluate the efficacy of soft tissue augmentation with platelet rich fibrin in order to overcome the patient morbidity with SCTG.

Study Overview

• Status: Unknown
• Conditions: Thin Gingival Biotype; Patients With at Least Single Missing Anterior Tooth
• Intervention / Treatment: Procedure: Platelet Rich Fibrin; Procedure: sub epithelial connective tissue graft

• Study Type: Interventional
• Enrollment (Anticipated): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Elmaniel
    • Cairo, Elmaniel, Egypt, 11311
      • Maymohamedkamal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients with missing maxillary anterior toot teeth.
2. Thin gingival biotype.
3. Adequate inter-arch space for placement of the implant prosthetic part.
4. Good oral hygiene where gingival index is (0, 1) (Loe and Silness 1963).

Exclusion Criteria:

1. Patient with medical condition that is contraindicated with the surgical procedure
2. Patients receiving treatment that affect the healing ability.
3. Patients with local pathological defects related to the area of interest.
4. Smokers or pregnant women.
5. Patients with parafunctional habits that may jeopardize the implant longevity and affect the results of the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Platelet Rich Fibrin for soft tissue augmentation; blood will be drawn from the patient vein for PRF. The blood sample will be centrifuged for 10-12 min. PRF membrane is obtained	Procedure: Platelet Rich Fibrin; : Platelet Rich Fibrin for soft tissue augmentation around implant in the aesthetic zone
Active Comparator: sub epithelial connective tissue graft; The connective tissue graft will be harvested from the palate. Then the SCTG will be placed over the recipient site extending palataly and sutured.	Procedure: sub epithelial connective tissue graft; sub epithelial connective tissue graft for soft tissue augmentation around implant in the aesthetic zone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Crestal bone resorption	measured mesially and distally using periapical xray in mm	6 months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): August 15, 2017
• Primary Completion (Anticipated): January 1, 2018
• Study Completion (Anticipated): January 1, 2018

Study Registration Dates

• First Submitted: July 10, 2017
• First Submitted That Met QC Criteria: July 14, 2017
• First Posted (Actual): July 18, 2017

Study Record Updates

• Last Update Posted (Actual): July 19, 2017
• Last Update Submitted That Met QC Criteria: July 17, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: PERIODONTOLOGYcairo university

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No