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

Thin Gingival Biotype Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03219944
• Other study ID #: PERIODONTOLOGYcairo university
• Status: Not yet recruiting
• Phase: N/A
• First received: July 10, 2017
• Last updated: July 17, 2017
• Start date: August 15, 2017
• Est. completion date: January 1, 2018

Study information

• Verified date: July 2017
• Source: Cairo University
• Contact: may mo kamal
• Phone: 01063392983
• Email: maykamalmo[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 16
• Est. completion date: January 1, 2018
• Est. primary completion date: January 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Patients With at Least Single Missing Anterior Tooth
• Thin Gingival Biotype

Intervention

Procedure:
• Platelet Rich Fibrin
: Platelet Rich Fibrin for soft tissue augmentation around implant in the aesthetic zone
• sub epithelial connective tissue graft
sub epithelial connective tissue graft for soft tissue augmentation around implant in the aesthetic zone

Locations

Country	Name	City	State
Egypt	Maymohamedkamal	Cairo	Elmaniel

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Crestal bone resorption	measured mesially and distally using periapical xray in mm	6 months