Evaluation of Advanced PRF Combined With Nano-crystalline Hydroxyapatite for Management of Grade II Furcation Defects

January 15, 2019 updated by: Hadeer Ashraf Hassan Roushdy

Clinical and Radiographic Evaluation of Advanced Platelet Rich Fibrin Combined With Nano-crystalline Hydroxyapatite Bone Substitute for Management of Mandibular Molar Grade II Furcation Defects

this study is to evaluate the use of advanced platelet rich fibrin (A-PRF) + nano-crystalline hydroxyapatite bone substitute combined with open flap debridement (OPD) versus open flap debridement alone in the management of mandibular molar grade II defects.

In the management of mandibular molar grade II furcation defects, no difference exists in gain of horizontal clinical attachment level between the use of advanced platelet rich fibrin (A-PRF) + with nano-crystalline hydroxyapatite bone substitute combined with open flap debridement (OPD) and open flap debridement (OPD) alone .

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

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.
28

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

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patient-related criteria:

  • Systemically healthy patients.
  • Compliance with oral hygiene instructions and the maintenance program provided.
  • Accepts the 6 months follow-up period.
  • Provide informed consent.

Teeth related criteria:

  • Mature permanent tooth.
  • Asymptomatic mandibular molar with buccal Glickman class II furcation involvement.
  • Probing depth (PD) ≥ 5 mm and vertical PD ≥ 3 mm after Phase I therapy (scaling and root planing).
  • Presence of radiolucency in the furcation area on an intra-oral periapical radiograph

Exclusion Criteria:

Patient-related criteria:

  • Patients taking drugs known to interfere with periodontal wound healing in the last six months.
  • Pregnant or nursing women.
  • Smokers.
  • Uncooperative patients.

Teeth related criteria:

  • Teeth with interproximal supra-bony or intrabony defects.
  • Teeth with gingival recession.
  • Teeth with grade II or III mobility.

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
  • Masking: NONE

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.
EXPERIMENTAL: Test Group
Advanced PRF (A-PRF) + nano-crystalline hydroxyapatite bone substitute combined with open flap debridement (OFD).
Procedure: Advanced PRF (A-PRF) + nano-crystalline hydroxyapatite bone substitute combined with open flap debridement

will treated with OFD +A- PRF+ nano-crystalline hydroxyapatite bone substitute,10 mL of blood will be drawn from only patient assigned to the intervention group by vein puncture of the antecubital vein and is collected in sterile glass test tube, without any anticoagulant.

  • The blood will be quickly collected, and the tube will immediately centrifuge at 1500 rpm for14 min at room temperature.
  • After centrifugation, the A-PRF clot will be removed from the tube using sterile tweezers and placed on sterile woven gauze. Membrane will prepared by compressing clots between two pieces of woven gauze.
ACTIVE_COMPARATOR: Control Group
Open flap debridement alone.
Procedure: Open flap debridement
a periodontal access flap will be initiated by intrasulcular incisions on the buccal and lingual aspects. The incisions will be carried as far interproximally as possible to preserve the entire Interdental papillae and to achieve primary wound closure.

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
Relative Vertical Clinical Attachment Level (RVCAL)
Time Frame: 6 months
relative vertical clinical attachment level (RVCAL) along with gingival marginal level (GML) will be measured from the apical level of customized acrylic stents with grooves to ensure a reproducible placement of a periodontal probe
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
Relative Horizontal Clinical Attachment Level (PHCAL)
Time Frame: 6 months
relative vertical clinical attachment level (RVCAL) along with gingival marginal level (GML) will be measured from the apical level of customized acrylic stents with grooves to ensure a reproducible placement of a periodontal probe
6 months
Probing Depth (PD)
Time Frame: 6 months
Probing depth measured from the gingival margin to the base of the pocket.
6 months
Gingival margin Level (GML)
Time Frame: 6 months
• Williams graduated probe will be used for vertical measurement and gingival margin level and Nabers probe for horizontal measurements.
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.
Hadeer Ashraf Hassan Roushdy

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 (ANTICIPATED)

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.
February 1, 2019

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.
November 1, 2019

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.
February 1, 2020

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).
January 11, 2019

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.
January 11, 2019

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.
January 15, 2019

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.
January 17, 2019

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.
January 15, 2019

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.
January 1, 2019

More Information

Terms related to this study

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.
  • perio2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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