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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

March 7, 2011
March 14, 2011
May 2010
January 2011   (final data collection date for primary outcome measure)
  • 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
  • Measuring periodontal health with several indices [ 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
Complete list of historical versions of study NCT01314729 on ClinicalTrials.gov Archive Site
  • 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
Not Provided
Not Provided
Not Provided
 
Comparison of the Effect of Two Types of Fixed Retainers on the Health of the Gums
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Diagnostic
Health of Periodontium
  • 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
  • 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
  • Active Comparator: Fiber-reinforced-composite retainer
    Intervention: Device: Fiber-reinforced-composite retainer
  • Active Comparator: composite-wire retainer
    Intervention: Device: Composite-wire retainer
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
48
May 2011
January 2011   (final data collection date for primary outcome measure)

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)
Both
13 Years to 18 Years
Yes
Contact: Sepideh Torkan, resident 0098 913327 1281 sepideh.torkan@yahoo.com
Iran, Islamic Republic of
 
NCT01314729
8901372055shirazUMS
Yes
Orthodontic Research Cneter, Shiraz Dental School
Shiraz University of Medical Sciences
Shiraz Dental School, Orthodontic Research Center
Principal Investigator: Morteza Oshagh, Associate professor Shiraz Dental School
Principal Investigator: Sepideh Torkan, resident Shiraz Dental School
Shiraz University of Medical Sciences
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP