Hydroxyapetite Nanoparticles, Tricalcium Phosphate Nanoparticles, and PRF for Treatment of Gingival Recession

August 24, 2023 updated by: Enas Elgendy, October 6 University

Comparative Study Between Hydroxyapetite Nanoparticles and Tricalcium Phosphate Nanoparticles Loaded on Platelet Rich Fibrin Membranes for Treatment of Gingival Recession

The aim of the present study was to compare between nanocrystalline hydroxyapatite and tricalcium phosphate carried on PRP membrane in treatment of Miller's class 1 gingival recession in human.

Study Overview

Status

Status

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

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.

Detailed Description

gingival recession (GR) is apical movement of the gingival margin beyond the cement-enamel junction. The use of free gingival grafts, sliding pedicle grafts, subepithelial connective tissue grafts, envelope or tunnelling techniques, the use of acellular dermal, connective tissue allografts, guided tissue regeneration, Platelet rich fibrin (PRF), and coronally advanced flap (CAF) are the surgical methods that have been developed to treat gingival recession. For treatments of intrabony defects, a synthetic nanocrystalline hydroxyapatite (NcHA) bone graft has been introduced. Osteoconductivity, bioresorbability, and close contact are benefits of NcHA material. Critical size defects showed quick healing when the NcHA was utilised as a bone graft alternative. NcHA binds to bone and increases osteoblast activity to promote bone regeneration. A promising bone replacement material, tricalcium phosphate (TCP) is known for its strong bioactivity and resorbable qualities. Tricalcium phosphate (TCP) is one of the most popular and effective artificial bone substitutes. It is osteoinductive as well as osteoconductive. These characteristics enable full bone defects regeneration together with its cell-mediated resorption. In this study, we compared between nanocrystalline hydroxyapatite and tricalcium phosphate carried on PRP membrane in treatment of Miller's class 1 gingival recession in human.

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 (Actual)

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

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

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients with good systemic health and no contraindication for periodontal surgery.
  • Patients who are able to maintain good oral hygiene.
  • Gingival thickness for the site selected should be ≥1mm.
  • The height of keratinized gingiva (HKG) for the site selected should be ≥1 mm (HKG is the distance between the most apical point of the gingival margin and the mucogingival junction).

Exclusion Criteria:

  • Active infectious diseases (hepatitis, tuberculosis, HIV, etc….).
  • Medically compromised patients.
  • Patients taking medications known to cause gingival enlargement.
  • Pregnant patients and smokers.
  • Previous mucogingival surgery at the defect.
  • Restorations or caries in the area to be treated and non vital tooth.
  • Teeth which are tilted or rotated.

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: Single

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.
Active Comparator: Nanocrystalline hydroxyapatite
Nanocrystalline hydroxyapatite loaded in PRF+ coronally advanced flap
Procedure: coronally advanced flap
coronally advanced flap operation
Other: Nanocrystalline hydroxyapatite loaded in PRF
Nanocrystalline hydroxyapatite loaded in PRF
Active Comparator: Nanocrystalline tricalcium phosphate (NcTCP)
Nanocrystalline tricalcium phosphate (NcTCP) loaded in PRF+ coronally advanced flap
Procedure: coronally advanced flap
coronally advanced flap operation
Other: Nanocrystalline tricalcium phosphate loaded in PRF
Nanocrystalline tricalcium phosphate (NcTCP) loaded in 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
Recession height
Time Frame: 6 months
measurement recession height
6 months
Recession width
Time Frame: 6 months
measurement of Recession width
6 months
Height of the keratinized tissue
Time Frame: 6 months
measurement of Height of the keratinized tissue
6 months
Percentage of root coverage
Time Frame: 6 months
It is calculated after 1, 3, 6 months as [RH preoperative - RH postoperative]/RH preoperative) x 100%.
6 months
Radiographic assessment
Time Frame: 6 months
measurement of buccal bone gain
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
Probing pocket depth
Time Frame: 6 months
measurement of Probing pocket depth
6 months
Clinical attachment level
Time Frame: 6 months
measurement of Clinical attachment level
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.
October 6 University

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.
September 1, 2000

Primary Completion (Actual)

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.
September 20, 2022

Study Completion (Actual)

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.
April 22, 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).
August 24, 2023

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.
August 24, 2023

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.
August 30, 2023

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.
August 30, 2023

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.
August 24, 2023

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.
August 1, 2023

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.
  • khafrelsheikh university

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

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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