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

Phase 3

• Conditions: Health of Periodontium
• Interventions: Device: Composite-wire retainer; Device: Fiber-reinforced-composite retainer

• Registration Number: NCT01314729
• Lead Sponsor: Shiraz University of Medical Sciences

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Primary Completion: 2011-01
• Status Verified: 2011-02
• Study First Submitted: 2011-03-07
• Study First Submitted QC: 2011-03-11
• Study First Posted: 2011-03-14
• Last Update Submitted: 2011-03-14
• Last Update Posted: 2011-03-15
• Study Completion: 2011-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 48

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)

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
composite-wire retainer	Composite-wire retainer	-
Fiber-reinforced-composite retainer	Fiber-reinforced-composite retainer	-

Primary Outcome Measures

Name	Time	Method
Measuring periodontal status through clinical examination	approximately 20 months	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	approximately 20 months	for each participant, the examination is carried out right after the completion of orthodontic treatment and after a 6-month-period

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Shiraz Dental School; 🇮🇷 Shiraz, Fars, Iran, Islamic Republic of