Comparison of the Effect of Two Types of Fixed Retainers on the Health of the Gums

March 14, 2011 updated by: Shiraz University of Medical Sciences

Clinical and Radiographic Comparison and Evaluation of Two Types of Lingual Fixed Retainers on the Health of Periodontium

Different types of retainers have been used to assure the stability of orthodontic treatment. The aim of this study is clinical and radiographic comparison and evaluation of two common types of lingual fixed retainers on the health of periodontium.

The participants in this study will be examined both clinically and radiographically just after the completion of orthodontic treatment and after a 6-month-period.

The results of the study will be analyzed with Mann-whitney and independent t-test.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

48

Phase

  • Phase 3

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

  • Iran, Islamic Republic of
    • Fars
      • Shiraz, Fars, Iran, Islamic Republic of, 7195615878
        • Recruiting
        • Shiraz Dental School
        • Contact:
        • Principal Investigator:
          • Morteza Oshagh, Associate professor
        • Principal Investigator:
          • Sepideh Torkan, postgradute student

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

Ages Eligible for Study

13 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. The patient who have completed orthodontic treatment
  2. The patients should be healthy with no systemic disease at the time
  3. In clinical examination no apparent periodontal disease or inflammation should be present
  4. Patients who have complete permanent dentition (3rd molar eruption is not required)

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: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Fiber-reinforced-composite retainer
Device: Fiber-reinforced-composite retainer
this type of retainer is placed on the lingual surface of teeth from canine to canine just before the completion of orthodontic treatment
ACTIVE_COMPARATOR: composite-wire retainer
Device: Composite-wire retainer
this type of retainer is placed on the lingual surface of teeth from canine to canine just before the completion of orthodontic treatment to prevent treatment relapse

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measuring periodontal status through clinical examination
Time Frame: approximately 20 months
for each participant, the examination is carried out right after the completion of orthodontic treatment and after a 6-month-period
approximately 20 months
measuring PDL width in periapical radiographs
Time Frame: approximately 20 months
for each participant, the examination is carried out right after the completion of orthodontic treatment and after a 6-month-period
approximately 20 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessing periodontial status with Gingival Index
Time Frame: approximately 20 months
A gingival Index score will be assigned to each patient upon completion of orthodontic treatment and after a 6-month-period
approximately 20 months
assessing periodontal status using Plaque Index
Time Frame: approximately 20 months
A plaque Index score will be assigned to each patient upon completion of orthodontic treatment and after a 6-month-period
approximately 20 months
assessing periodontal status using Calculus Index
Time Frame: approximately 20 months
A Calculus Index score will be assigned to each patient upon completion of orthodontic treatment and after a 6-month-period
approximately 20 months
assessing periodontal status using Bleeding on probing
Time Frame: approximately 20 months
Each patient will be examined for bleeding on probing upon completion of orthodontic treatment and after a 6-month-period
approximately 20 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shiraz University of Medical Sciences

Collaborators

Shiraz Dental School, Orthodontic Research Center

Investigators

  • Principal Investigator: Morteza Oshagh, Associate professor, Shiraz Dental School
  • Principal Investigator: Sepideh Torkan, resident, Shiraz Dental School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

May 1, 2010

Primary Completion (ACTUAL)

January 1, 2011

Study Completion (ANTICIPATED)

May 1, 2011

Study Registration Dates

First Submitted

March 7, 2011

First Submitted That Met QC Criteria

March 11, 2011

First Posted (ESTIMATE)

March 14, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

March 15, 2011

Last Update Submitted That Met QC Criteria

March 14, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 8901372055shirazUMS

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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