Microsurgical Instruments and Magnification May Enhance Treatment Outcomes Of Laterally Moved, Coronally Advanced Flap in Miller Class III Isolated Recession Defects

October 31, 2014 updated by: Onur Ozcelik, Cukurova University

The benefits of microsurgical approaches in periodontal therapy have been described. The main focus of this study is to determine if using microsurgical LMCAF technique would improve the outcomes of the therapy for the Miller Class III isolated recession-type defects.

Six months results of this study showed that LMCAF with microsurgical approach offered better complete and mean root coverage results over macrosurgical LMCAF technique. The superior effect of microsurgical approach on post-operative morbidity can make this technique more preferable for the patients who expected comfortable postoperative period.

This study supports that using the microsurgical aproach with LMCAF procedure significantly affects the clinical and patient-centered success of treating Miller Class III isolated typed defects.

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.

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.
50

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

  • Turkey
      • Adana, Turkey, 01330
        • Cukurova University

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

22 years to 39 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Presence of Miller Class III isolated gingival recessions located at upper and lower incisors and canines (Miller 1985)
  • Presence of identifiable cementoenamel junction (CEJ)
  • Presence of a step ≤ 2mm at CEJ level and/or the presence of a root abrasion, but with an identifiable CEJ
  • Lateral keratinized tissue width at least 6 mm greater than the width of the recession measured at the level of the cemento-enamel junction (CEJ)
  • Lateral keratinized tissue height at least 2 mm greater than the buccal probing depth of the adjacent tooth/teeth
  • Full-mouth plaque score and full-mouth bleeding score of < 15% (four sites/tooth) -No occlusal interferences; all patients were nonsmokers

Exclusion Criteria:

  • Tooth with a prosthetic crown or restoration involving CEJ
  • Patients with a history of destructive periodontal disease (o zaman class 3 nasıl oluştu demiş adam) or repeated abscess formation
  • Presence of systemic disease or taking medications known to interfere with periodontal tissue health or healing (patients with insulin-dependent diabetes
  • History of malignancy, radiotherapy, or chemotherapy for malignancy
  • Disease affecting connective tissue metabolism)
  • Patient pregnant or nursing during the past 5 months
  • Patients who participated in a clinical trial within the past 6 months

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.
Experimental: laterally moved coronally advanced flap microsurgical
For the test group (LMCAF-M), the surgical procedures were performed with the aid of a galilean loupe, under 2.5x magnification vision, microsurgical instruments and microsurgical suture material .
Procedure: laterally moved coronally advanced flap with microsurgical instruments and x2.5 loupe
The recipient area for the laterally moved flap was prepared. When the flap was moved in the distal-mesial direction another short horizontal incision was performed at the most apical extension of this vertical incision. Once the mucogingival line was reached, flap elevation was continued split-thickness. Flap elevation was terminated when it was possible to passively move the flap laterally above the exposed root. Flap was sutured.
Active Comparator: laterally moved coronally advanced flap macrosurgical
For the control group (LMCAF), LMCAF was performed with conventional instruments (detaylı) and materials (stur). Loupe magnification, microsurgical instruments and suture material were not used in the control group.
Procedure: laterally moved coronally advanced flap with microsurgical instruments and x2.5 loupe
The recipient area for the laterally moved flap was prepared. When the flap was moved in the distal-mesial direction another short horizontal incision was performed at the most apical extension of this vertical incision. Once the mucogingival line was reached, flap elevation was continued split-thickness. Flap elevation was terminated when it was possible to passively move the flap laterally above the exposed root. Flap was sutured.

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
Time Frame
the percentage of root coverage
Time Frame: at 6 months
at 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.
Cukurova 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

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, 2012

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.
March 1, 2013

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.
October 1, 2014

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).
October 30, 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 31, 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.
November 2, 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.
November 2, 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 31, 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

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.
  • CukurovaU2

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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