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

May 20, 2022 updated by: Basima Ghaffoori Ali, University of Baghdad

The Value of Injectable Platelet Rich Fibrin With Volume Stable Collagen Matrix in Treatment of Multiple Gingival Recession; a Randomized Clinical Trial.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iraq
      • Baghdad, Iraq, 10047
        • University of Baghdad / College of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Control arm
Patients with Gingival recessions are type 1 recession RT1 (cairo et al,2011) which correspond to Miller I&II gingival recession.
Procedure: CAF+CM
Periodontal surgery including CAF+CM application
Other: Experimental arm
Patients with Gingival recessions are type 1 recession RT1 (cairo et al,2011) which correspond to Miller I&II gingival recession.
Procedure: CAF+CM
Periodontal surgery including CAF+CM application
Procedure: I-PRF
Periodontal surgery including CAF+CM application with i-PRF

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Reduction in gingival recession depth on the buccal sides of type one gingival recessionRT1
Time Frame: Between the baseline preoperative measurement and follow-up at 3 months and 6 months
The primary outcome of the study is the reduction in gingival recession depth on the buccal sides of RT1 gingival recession, between the baseline preoperative measurement and follow-up at 3 months and 6 months. The Recession Depth (RD) is Measured in millimeter (mm) from CEJ (Cemento-Enamel-Junction) to the gingival margin using UNC-15 probe.
Between the baseline preoperative measurement and follow-up at 3 months and 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Improvement in Gingival Thickness (GT)
Time Frame: Between the baseline preoperative measurement and follow-up at 3 months and 6 months
Gingival Thickness (GT) is determined at 1.5 mm apical to the gingival margin using a caliper (endodontic reamer#20) rounded to the nearest 0.1mm.
Between the baseline preoperative measurement and follow-up at 3 months and 6 months
Improvement in the Keratinized Tissue Height (KTH)
Time Frame: Between the baseline preoperative measurement and follow-up at 3 months and 6 months
Keratinized Tissue Height (KTH) is measured in millimeters (mm) taken at the mid buccal aspect of the involved teeth from the gingival margin to the muco-gingival junction, by a manual periodontal probe (UNC-15 probe,Hu-Friedy,Chicago,USA).
Between the baseline preoperative measurement and follow-up at 3 months and 6 months
Reduction in the Recession Width (RW)
Time Frame: Between the baseline preoperative measurement and follow-up at 3 months and 6 months
Recession Width (RW) is measured in millimeter (mm) at the Cement-Enamel Junction (CEJ) using UNC-15 probe.
Between the baseline preoperative measurement and follow-up at 3 months and 6 months
Reduction in Probing Pocket Depth (PPD)
Time Frame: Between the baseline preoperative measurement and follow-up at 3 months and 6 months
Probing Pocket Depth (PPD) is measured in millimeter (mm) from the gingival margin to the apical extend of the probe.
Between the baseline preoperative measurement and follow-up at 3 months and 6 months
Reduction Clinical Attachment Level (CAL)
Time Frame: Between the baseline preoperative measurement and follow-up at 3 months and 6 months
Clinical Attachment Level (CAL) is measured in millimeter (mm) from the CEJ to the apical extend of the probe.
Between the baseline preoperative measurement and follow-up at 3 months and 6 months
Measuring Plaque-Index (PI)
Time Frame: Between the baseline preoperative measurement and follow-up at 3 months and 6 months
Plaque-Index (PI) is measured as a percentage of the presence of Plaque on four surfaces of the teeth using a manual periodontal probe.
Between the baseline preoperative measurement and follow-up at 3 months and 6 months
Measuring Bleeding On Probing (BOP)
Time Frame: Between the baseline preoperative measurement and follow-up at 3 months and 6 months
Bleeding On Probing (BOP) is measured as a percentage of sites with bleeding on probing using a manual periodontal probe.
Between the baseline preoperative measurement and follow-up at 3 months and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Baghdad

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Basima Gh Ali, MSc, university of Baghdad, college of dentistry
  • Study Director: Thair AL Hassan, PHD, university of Baghdad, college of dentistry

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 25, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 30, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 24, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 24, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 24, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 519622

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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