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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Shiraz University of Medical Sciences.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Shiraz Dental School, Orthodontic Research Center
Information provided by:
Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01314729
First received: March 7, 2011
Last updated: March 14, 2011
Last verified: February 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Health of Periodontium
 Device: Fiber-reinforced-composite retainer
Device: Composite-wire retainer
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Clinical and Radiographic Comparison and Evaluation of Two Types of Lingual Fixed Retainers on the Health of Periodontium

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Shiraz University of Medical Sciences:

Primary Outcome Measures:
  • Measuring periodontal status through clinical examination [ Time Frame: approximately 20 months ] [ Designated as safety issue: Yes ]
    for each participant, the examination is carried out right after the completion of orthodontic treatment and after a 6-month-period

  • measuring PDL width in periapical radiographs [ Time Frame: approximately 20 months ] [ Designated as safety issue: Yes ]
    for each participant, the examination is carried out right after the completion of orthodontic treatment and after a 6-month-period


Secondary Outcome Measures:
  • Assessing periodontial status with Gingival Index [ Time Frame: approximately 20 months ] [ Designated as safety issue: Yes ]
    A gingival Index score will be assigned to each patient upon completion of orthodontic treatment and after a 6-month-period

  • assessing periodontal status using Plaque Index [ Time Frame: approximately 20 months ] [ Designated as safety issue: Yes ]
    A plaque Index score will be assigned to each patient upon completion of orthodontic treatment and after a 6-month-period

  • assessing periodontal status using Calculus Index [ Time Frame: approximately 20 months ] [ Designated as safety issue: Yes ]
    A Calculus Index score will be assigned to each patient upon completion of orthodontic treatment and after a 6-month-period

  • assessing periodontal status using Bleeding on probing [ Time Frame: approximately 20 months ] [ Designated as safety issue: Yes ]
    Each patient will be examined for bleeding on probing upon completion of orthodontic treatment and after a 6-month-period


Estimated Enrollment: 48
Study Start Date: May 2010
Estimated Study Completion Date: May 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   13 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01314729

Contacts
Contact: Sepideh Torkan, resident 0098 913327 1281 sepideh.torkan@yahoo.com

Locations
Iran, Islamic Republic of
Shiraz Dental School Recruiting
Shiraz, Fars, Iran, Islamic Republic of, 7195615878
Contact: Sepideh Torkan, resident     0098913 3271281     sepideh.torkan@yahoo.com    
Principal Investigator: Morteza Oshagh, Associate professor            
Principal Investigator: Sepideh Torkan, postgradute student            
Sponsors and Collaborators
Shiraz University of Medical Sciences
Shiraz Dental School, Orthodontic Research Center
Investigators
Principal Investigator: Morteza Oshagh, Associate professor Shiraz Dental School
Principal Investigator: Sepideh Torkan, resident Shiraz Dental School
  More Information

No publications provided

Responsible Party: Orthodontic Research Cneter, Shiraz Dental School
ClinicalTrials.gov Identifier: NCT01314729     History of Changes
Other Study ID Numbers: 8901372055shirazUMS
Study First Received: March 7, 2011
Last Updated: March 14, 2011
Health Authority: Iran: Shiraz University of Medical Sciences

Keywords provided by Shiraz University of Medical Sciences:
Orthodontic fixed retainer
fiber-reinforced-composite retainer
composite-wire retainer

ClinicalTrials.gov processed this record on May 19, 2013