The Influence of Citric Acid Bone Surface Etching and Bone Defect Fill on GCF BMP-2 Release Profile

December 6, 2018 updated by: Moustafa Mukhtar, Ain Shams University

The Influence of Citric Acid Bone Surface Etching and Bone Substitute Intra-osseous Defect Fill on Crevicular Fluid BMP-2 Release Profile (Randomized Clinical Trial)

This study evaluates the effect of citric acid on bone surface of infrabony defects when used for 30 seconds at ph 1 and 50% concentration before the application of bovine derived xenograft to fill the defect, Bone Morphogenic protein 2 (BMP-2) marker was evaluated in 5 different days during the first month after surgery and clinical and radiographic parameters were reassessed after 6 months

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

Citric acid have been widely used to treat root surfaces of periodontally affected teeth in order to render it biologically suitable for fibroblast reattachment. however, systematic reviews showed no clinical significance when it was used as a root surface conditioner. Recently it was found in experimental studies that when citric acid was used on bone surface for a brief period, it increased bone formation and improved consolidation of grafted bone to bone bed. In this study infrabony defects were treated with citric acid PH 1 and 50% concentration for 30 seconds before washing it off and then application of bovine derived xenograft was done to fill the defect. BMP-2 marker was evaluated at days 1,3,7,14 and 30 by taking a sample using perio-paper from the gingival crevicular fluid (GCF) and clinical and radiographic parameters were taken after 6 months of follow-up

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.
  • Phase 4

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

20 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Both genders aged between 32-60 years.

  • Selected patient with a single site of:

    1. Two walled or three walled infra-bony defect.
    2. The bone defect should be at least 3 mm in depth from the crest of the alveolar bone to the base of the defect.
    3. Pocket depth of more than or equal to 5 mm.
    4. Clinical attachment loss equal or more than 3mm
  • Patients ready to comply with oral hygiene measures.

Exclusion Criteria:

  • Any systemic disease that contra-indicates periodontal surgery or may affect healing.
  • Smokers
  • Pregnant females
  • Drug abusers

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: 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: Citric acid
Citric acid PH1 and concentration 50% was used for 30 seconds on bone surface before washing it off and filling the defect with xenograft
Drug: Citric acid
Citric acid ph1, 50% concentration solution
PLACEBO_COMPARATOR: Control
Control test
Drug: Control Test
Control group, xenograft was used to fill infrabony defects without treating bone surface
Other Names:
  • Control

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
Bone Morphogenic protein 2
Time Frame: 1 day
The level of Bone morphogenic protein 2 was measured in the gingival crevicular fluid using a perio-paper then the marker level was determined using an Enzyme linked immunosorbent kit (ELISA kit)
1 day
Bone Morphogenic protein 2
Time Frame: 3 days
The level of Bone morphogenic protein 2 was measured in the gingival crevicular fluid using a perio-paper then the marker level was determined using an Enzyme linked immunosorbent kit (ELISA kit)
3 days
Bone Morphogenic protein 2
Time Frame: 7 days
The level of Bone morphogenic protein 2 was measured in the gingival crevicular fluid using a perio-paper then the marker level was determined using an Enzyme linked immunosorbent kit (ELISA kit)
7 days
Bone Morphogenic protein 2
Time Frame: 14 days
The level of Bone morphogenic protein 2 was measured in the gingival crevicular fluid using a perio-paper then the marker level was determined using an Enzyme linked immunosorbent kit (ELISA kit)
14 days
Bone Morphogenic protein 2
Time Frame: 30 days
The level of Bone morphogenic protein 2 was measured in the gingival crevicular fluid using a perio-paper then the marker level was determined using an Enzyme linked immunosorbent kit (ELISA kit)
30 days

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
Gingival Index
Time Frame: 6 months
Estimation of the degree of gingival inflammation was done according to Loe where scores were given between 0-3 (0=no inflammation and 3=severe inflammation)
6 months
Plaque index
Time Frame: 6 months
Estimation of the amount of dental plaque according to Silness & Loe where scores were given between 0-3 (0=no plaque and 3=presence of abundant plaque)
6 months
Probing depth
Time Frame: 6 months
Estimation was done by measuring the depth from the gingival margin to the base of the periodontal pocket using a UNC-15 periodontal probe
6 months
Clinical attachment level
Time Frame: 6 months
Estimation was done by measuring the distance from the cemento-enamel junction to the base of the pocket using a UNC-15 periodontal probe
6 months
Radiographic bone fill
Time Frame: 6 months
Estimation was done by taking a linear measurement using RVG system from the baseline defect till the alveolar bone crest
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.
Ain Shams 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.
January 1, 2016

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.
May 1, 2018

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.
November 1, 2018

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).
December 6, 2018

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.
December 6, 2018

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.
December 7, 2018

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.
December 7, 2018

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.
December 6, 2018

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.
December 1, 2018

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.
  • 52-376

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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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