Comparative evaluation of moisture insensitive and conventional based orthodontic adhesive systems: A Randomised Control trial.
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 616
- Locations
- 1
- Primary Endpoint
- BOND FAILURE RATE
Study Overview
Brief Summary
**Orthodontic treatment with brackets generall****y takes 1-2 years of time.**Most of the current orthodontic bonding materials are composite resins based on the bis-GMA formula. Although the use of these materials is well accepted, one major problem is the need for obtaining and maintaining a completely dry operating field throughout the bonding procedure .This is important because moisture contamination of the enamel surface is regarded as the commonest reason of bond failure. Bond failure of bracket retards treatment and is costly in terms of time, material and patient inconvenience. Hence, there was introduction of moisture resistant composite materials. The present study is designed to evaluate and compare the bond failure rate of Transbond MIP and Transbond XT as moisture insensitive and conventional materials respectively when used for direct bonding of orthodontic brackets.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 13.00 Year(s) to 45.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Permanent Dentition 2.Type of malocclusion including Class I, Class II & Class III 3.Adolescent or Adult Patients 4.Both Extraction and Non-Extraction Cases.
Exclusion Criteria
- •1.Teeth with facial/buccal restorations or Congenital defects 2.Teeth which are not fully erupted.
- •3.Dentition with occlusal interferences and deep bite hindering proper bracket Positioning.
- •4.Bracket failure caused by known operator error.
- •5.Patient with previous orthodontic treatment.
Outcomes
Primary Outcomes
BOND FAILURE RATE
Time Frame: 6 months
Secondary Outcomes
- Adhesive Remnant Index(6 months)
Investigators
Dr Radheya P Agrawal
Government Dental College and Hospital ,Cuddalore(erstwhile Rajah Muthiah Dental College)