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The Effect of (L-PRF) Membrane in The Treatment of Gingival Recession

NCT ID: NCT04224935

Last Updated: 2020-11-05

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

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-01

Study Completion Date

2020-01-01

Brief Summary

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evaluation of the use of L-PRF membrane with coronally repositioned flap in treatment of localized gingival recession (Class I \& II) in comparison with the use of connective tissue graft

Detailed Description

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Twenty patients, who are candidates for gingival recession coverage, will participate in this prospective clinical trial.

Group 1(10 patients) :

Coronally repositioned flap will be done and L PRF membrane will be placed into the tissues

Group 2 (Control group)(10 patients) :

Coronally repositioned flap will be done with sub epithelial connective tissue Parameters

* Clinical evaluation of percentage of root coverage and keratinized tissue width
* Esthetic outcome evaluation Will be done using the root coverage esthetic score (Cairo et al. 2009) that include

Both evaluations will be done at 3, 6 and 9 months

Conditions

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Localized Gingival Recession

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Leukocyte Platelet Rich Fibrin

Leukocyte Platelet Rich Fibrin will be used

Group Type ACTIVE_COMPARATOR

Leukocyte Platelet rich fibrin membrane

Intervention Type PROCEDURE

the use of Leukocyte Platelet rich fibrin as grafting materials for treatment of recession

connective tissue

connective tissue will be used

Group Type ACTIVE_COMPARATOR

Leukocyte Platelet rich fibrin membrane

Intervention Type PROCEDURE

the use of Leukocyte Platelet rich fibrin as grafting materials for treatment of recession

Interventions

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Leukocyte Platelet rich fibrin membrane

the use of Leukocyte Platelet rich fibrin as grafting materials for treatment of recession

Intervention Type PROCEDURE

Other Intervention Names

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sub epithelial connective tissue

Eligibility Criteria

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Inclusion Criteria

* Systemically free patients (American Society of Anesthesiologists I; ASA I).
* Age range (20 -40) years.
* Good compliance with the plaque control instructions following initial therapy.
* Patients diagnosed with Miller class I or II in anterior and premolar teeth
* Availability for follow up and maintenance program.

Exclusion Criteria

* Patient suffering from periodontitis
* Presence of smoking habit.
* Presence of occlusion interference.
* Pregnant and lactating females.
* Vulnerable group of patients (handicapped, mentally retarded and prisoners).
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Zainab Hafez Abdel Rahman

teaching assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ahmed abdel aziz, co professor

Role: STUDY_CHAIR

faculty of dentistry ain shams university

Locations

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Faculty of Dentistry Ain Shams University

Cairo, , Egypt

Site Status

Countries

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Egypt

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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453

Identifier Type: -

Identifier Source: org_study_id