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

NCT ID: NCT03219944

Last Updated: 2017-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-15

Study Completion Date

2018-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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Patients With at Least Single Missing Anterior Tooth Thin Gingival Biotype

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Platelet Rich Fibrin

Intervention Type PROCEDURE

: Platelet Rich Fibrin for soft tissue augmentation around implant in the aesthetic zone

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.

Group Type ACTIVE_COMPARATOR

sub epithelial connective tissue graft

Intervention Type PROCEDURE

sub epithelial connective tissue graft for soft tissue augmentation around implant in the aesthetic zone

Interventions

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Platelet Rich Fibrin

: Platelet Rich Fibrin for soft tissue augmentation around implant in the aesthetic zone

Intervention Type PROCEDURE

sub epithelial connective tissue graft

sub epithelial connective tissue graft for soft tissue augmentation around implant in the aesthetic zone

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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may mohamed kamal

master student

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Maymohamedkamal

Cairo, Elmaniel, Egypt

Site Status

Countries

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Egypt

Central Contacts

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may mo kamal

Role: CONTACT

01063392983

Facility Contacts

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may mo kamal

Role: primary

01063392983

Other Identifiers

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PERIODONTOLOGYcairo university

Identifier Type: -

Identifier Source: org_study_id

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