Injectable Platelet Rich Fibrin With Collagen Matrix in Treatment of Multiple Gingival Recession.

NCT ID: NCT05389059

Last Updated: 2022-05-24

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-25

Study Completion Date

2023-09-01

Brief Summary

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This study is proposing the use of i-PRF clot as a scaffold for the XCM in order to obtain a novel biomaterial, incorporating active growth factors and collagen matrix in a single framework, based on the potential effect of i-PRF to enhance fibroblast activity and angiogenesis stimulation for treatment of multiple gingival recession.

Detailed Description

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Conditions

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Gingival Diseases Traumatic Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Control arm

Patients with Gingival recessions are type 1 recession RT1 (cairo et al,2011) which correspond to Miller I\&II gingival recession.

Group Type OTHER

CAF+CM

Intervention Type PROCEDURE

Periodontal surgery including CAF+CM application

Experimental arm

Patients with Gingival recessions are type 1 recession RT1 (cairo et al,2011) which correspond to Miller I\&II gingival recession.

Group Type OTHER

CAF+CM

Intervention Type PROCEDURE

Periodontal surgery including CAF+CM application

I-PRF

Intervention Type PROCEDURE

Periodontal surgery including CAF+CM application with i-PRF

Interventions

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CAF+CM

Periodontal surgery including CAF+CM application

Intervention Type PROCEDURE

I-PRF

Periodontal surgery including CAF+CM application with i-PRF

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Presence of at least two localized gingival recessions on either sides of the maxilla and/or mandible excluding molar region.
* The cemento-enamel junction (CEJ) is visible in the teeth for root coverage procedures.
* All recessions are type 1recession RT1 (cairo et al,2011) which correspond to Miller I\&II gingival recession
* All patients must demonstrate adequate plaque control with a fullmouth plaque score less than 20% and with .
* All patients at least 18 years of age and of both genders.

Exclusion Criteria

* Smoker Patients .
* Patients with diabetes.
* Patients with a history of malignancy, radiotherapy, or chemotherapy for malignancy.
* pregnant or nursing women.
* Patients taking medications or having treatments with an effect on mucosal healing in general (e.g. steroids, large doses of antiinflammatory drugs).
* Patients with a disease affecting connective tissue metabolism.
* Patients allergic to collagen.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Baghdad

OTHER

Sponsor Role lead

Responsible Party

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Basima Ghaffoori Ali

PHD student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Basima Gh Ali, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Baghdad

Thair AL Hassan, PHD

Role: STUDY_DIRECTOR

University of Baghdad

Locations

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University of Baghdad / College of Dentistry

Baghdad, , Iraq

Site Status

Countries

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Iraq

Other Identifiers

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519622

Identifier Type: -

Identifier Source: org_study_id

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