Root Biomodification With Citric Acid and Tetracycline Improves the Outcomes of Root Coverage

October 5, 2014 updated by: Adriana Campos Passanezi SantAna, University of Sao Paulo

Conditioning of Root Surfaces With Citric Acid and Tetracycline for Different Application Times Improves the Outcomes of Root Coverage by Subepithelial Connective Tissue Graft: a Randomized Clinical Trial.

The aim of this study is to investigate the effects of the application of a citric acid + tetracycline gel solution during 90 or 180 seconds compared to no conditioning in the outcomes of treatment of Miller's class I or II recession defects by subepithelial connective tissue graft.

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

Adult patients showing Miller's class I or II recession defects requiring root coverage were recruited to participate in the study. All patients were submitted to non surgical periodontal therapy consisting of scaling and root planing, prophylaxis, and oral hygiene instruction in order to reduce/eliminate gingival inflammation. After that, patients were randomly allocated to three different treatment groups based on root conditioning: G0- no conditioning; G90- root conditioning for 90 seconds; G180- root conditioning for 180 seconds. Allocation was defined by a software. Root coverage was performed by subepithelial connective tissue graft (SCTG) in all treated sites by the same operator, who performed the indicated root treatment. Periodontal parameters were investigated at baseline and at 1, 3, 6 and 12 months post-operatively by a blinded trained expertise different from operator and included: pocket depth, recession height, clinical attachment level, width of keratinized gingiva, sulcular bleeding index and plaque index. Hypersensitivity at recession sites was also investigated at baseline and at 7 days, 14 days, 1, 3, 6 and 12 months after treatment according to visual analogic scale (VAS).

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.
36

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

  • Brazil
    • São Paulo
      • Bauru, São Paulo, Brazil, 17012-912
        • School of Dentistry at Bauru- University of São Paulo; Clinics of Periodontics

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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • presence of Miller's class I or II recession extending 2-5 mm apical to CEJ requiring root coverage for the following reasons: esthetics, progression of recession or hypersensitivity.

Exclusion Criteria:

  • smokers;
  • pregnants;
  • routine use of anti-convulsants, anti-hypertensive or cyclosporine;
  • uncontrolled systemic diseases (e.g.: diabetes mellitus);
  • systemic conditions that requires antibiotic prophylaxis (e.g.: history of bacterial endocarditis; rheumatoid arthritis; prosthetic valves);
  • antibiotics, steroidal or non-steroidal anti-inflammatory intake in the 6-month previous period.

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: Triple

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.
No Intervention: G0
Root decontamination performed by scaling and root planing followed by rinsing with saline solution during the treatment of recession defects by subepithelial connective tissue graft (SCTG). Control group.
Active Comparator: G90
Root conditioning with citric acid+tetracycline solution (1:1) for 90 seconds after scaling and root planing, followed by rinsing with saline solution for root decontamination during the treatment of recession defects by subepithelial connective tissue graft (SCTG).
Other: Root conditioning with citric acid+tetracycline solution
Application of a citric acid + tetracycline gel solution (1:1) for decontamination of root surfaces during the treatment of recession defects by subepithelial connective tissue graft
Active Comparator: G180
Root conditioning with citric acid+tetracycline solution (1:1) for 180 seconds after scaling and root planing, followed by rinsing with saline solution for root decontamination during the treatment of recession defects by subepithelial connective tissue graft (SCTG).
Other: Root conditioning with citric acid+tetracycline solution
Application of a citric acid + tetracycline gel solution (1:1) for decontamination of root surfaces during the treatment of recession defects by subepithelial connective tissue graft

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
percentage of root coverage (%REC)
Time Frame: one year
Percentage of root coverage obtained at 1 year after procedure. Represented by the difference of baseline recession height and final recession height divided by baseline recession height multiplied by 100 (in percentage).
one year

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
reduction in recession height
Time Frame: one year
Linear difference between final recession height and baseline recession height, measured by a millimeter periodontal probe as the distance from cementum-enamel junction and gingival margin at the center of recession defect (in mm).
one year
increase in the width of keratinized gingiva
Time Frame: one year
Linear difference between final and baseline width of keratinized gingiva. Measured with a millimeter periodontal problem as the distance from gingival margin to mucogingival junction (in mm).
one year
gain in clinical attachment level
Time Frame: one year
Linear difference between final and baseline clinical attachment level. Measured with a millimeter periodontal probe as the distance from cementum-enamel junction and the bottom of the sulcus or pocket (in mm).
one year

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
reduction in probing depth
Time Frame: one year
Linear difference of final and baseline probing pocket measurements. Measured with a millimeter periodontal probe as the distance between gingival margin and the bottom of the sulcus or pocket (in mm).
one year
reduction in bleeding index
Time Frame: one year
Difference in the presence (score 1) or absence (0) of bleeding on probing, up to 10 seconds after removal of the probe from the sulcus (index; percentage)
one year
reduction in plaque index
Time Frame: one year
Difference in the presence (score 1) or absence (score 0) of plaque accumulation, visually determined (index; percentage)
one year

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 Sao Paulo

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Fundação de Amparo à Pesquisa do Estado de São Paulo

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: João Paulo C Barros, Master, Graduation student

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

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.
August 1, 2011

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.
December 1, 2012

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.
March 1, 2013

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).
September 28, 2014

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.
October 5, 2014

First Posted (Estimate)

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.
October 8, 2014

Study Record Updates

Last Update Posted (Estimate)

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.
October 8, 2014

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.
October 5, 2014

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.
October 1, 2014

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.
  • 018/2010

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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