Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06567730
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-16
Brief Title:
Comparison of Canine Retraction Using Ni-ti Closed-coil Springs Vs Elastomeric Power Chains During Orthodontic Treatment
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comprehensive Comparison of Canine Retraction Using Nickel-titanium Closed-coil Springs Versus Elastomeric Power Chains During Orthodontic Treatment - A Split-mouth Randomized Controlled
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this study is to compare the canine retraction rate in mm with a 100 mm marked scale using Ni-Ti closed-coil springs versus elastomeric power chains during canine retraction in subjects with first premolar extractions over a period of three months
After the extraction of all first premolars under local anesthesia For canine retraction Ni-Ti closed-coil springs and elastomeric power chains will be randomly allocated to the right and left quadrants of both arches
Radiographic measurement root resorption and clinical measurements canine retraction plaque accumulation and gingival health will be recorded at four points in time First at the start of the canine retraction T0 after first month T1 second month T2 and third month follow-up T3
After the extraction of all first premolars under local anesthesia For canine retraction Ni-Ti closed-coil springs and elastomeric power chains will be randomly allocated to the right and left quadrants of both arches
Radiographic measurement root resorption and clinical measurements canine retraction plaque accumulation and gingival health will be recorded at four points in time First at the start of the canine retraction T0 after first month T1 second month T2 and third month follow-up T3
Detailed Description:
RATIONALE
Premolar extraction followed by canine retraction is one of the common practices in orthodontics to treat malocclusion such as severe crowding and proclination of anterior teeth It is essential to know methods and techniques that result in minimum or no adverse effects on roots of teeth and periodontal health This will help the clinicians to choose the best method that will result in a faster and more physiological closure of extraction spaces Moreover to the best of our knowledge limited studies have compared the effects of Ni-Ti closed-coil springs and elastomeric power chains on canine root resorption gingival health and plaque accumulation It is necessary to establish a comparison between these methods as it can help clinicians to provide better care and enhance the overall effectiveness of orthodontic treatment
OBJECTIVE
Primary Objective The objective of this study is to compare the canine retraction rate in mm with a 100 mm marked scale using Ni-Ti closed-coil springs versus elastomeric power chains during canine retraction in subjects with first premolar extractions over a period of three months
Secondary Objective This study will also include an assessment of canine root resorption in mm using periapical radiograph dental plaque accumulation and gingival health according to indices mentioned below with CPI-TN probe using Ni-Ti closed-coil springs versus elastomeric power chains during canine retraction in subjects with first premolar extractions over a period of three months
HYPOTHESIS
Null Hypothesis There is no significant difference between Ni-Ti closed-coil spring and elastomeric power chain on the canine root resorption retraction rate dental plaque accumulation and gingival health in subjects with first premolar extractions
Alternate Hypothesis There is a significant difference between Ni-Ti closed-coil spring and elastomeric power chain on the canine root resorption retraction rate dental plaque accumulation and gingival health in subjects with first premolar extractions
DATA COLLECTION PROCEDURE
After obtaining an approval from the Ethical Review Committee and taking informed consent and informed assent from the parents and child respectively these patients will be recruited in the study as participants Patients visiting the orthodontic clinic at the Aga Khan University Hospital Karachi will be included in this study Detailed information regarding the study will be provided to the participants and they will be given the choice to either accept or refuse their inclusion in the study After the extraction of all first premolars under local anesthesia 0018 stainless steel archwires will be inserted in the maxillary and mandibular arches For canine retraction Ni-Ti closed-coil springs and elastomeric power chains will be randomly allocated to the right and left quadrants of both arches Radiographic measurement root resorption and clinical measurements canine retraction plaque accumulation and gingival health will be recorded at four points in time First at the start of the canine retraction T0 after first month T1 second month T2 and third month follow-up T3 Canine retraction rate will be recorded by using a 100 mm marked scale Data will be collected on an organized study proforma
Premolar extraction followed by canine retraction is one of the common practices in orthodontics to treat malocclusion such as severe crowding and proclination of anterior teeth It is essential to know methods and techniques that result in minimum or no adverse effects on roots of teeth and periodontal health This will help the clinicians to choose the best method that will result in a faster and more physiological closure of extraction spaces Moreover to the best of our knowledge limited studies have compared the effects of Ni-Ti closed-coil springs and elastomeric power chains on canine root resorption gingival health and plaque accumulation It is necessary to establish a comparison between these methods as it can help clinicians to provide better care and enhance the overall effectiveness of orthodontic treatment
OBJECTIVE
Primary Objective The objective of this study is to compare the canine retraction rate in mm with a 100 mm marked scale using Ni-Ti closed-coil springs versus elastomeric power chains during canine retraction in subjects with first premolar extractions over a period of three months
Secondary Objective This study will also include an assessment of canine root resorption in mm using periapical radiograph dental plaque accumulation and gingival health according to indices mentioned below with CPI-TN probe using Ni-Ti closed-coil springs versus elastomeric power chains during canine retraction in subjects with first premolar extractions over a period of three months
HYPOTHESIS
Null Hypothesis There is no significant difference between Ni-Ti closed-coil spring and elastomeric power chain on the canine root resorption retraction rate dental plaque accumulation and gingival health in subjects with first premolar extractions
Alternate Hypothesis There is a significant difference between Ni-Ti closed-coil spring and elastomeric power chain on the canine root resorption retraction rate dental plaque accumulation and gingival health in subjects with first premolar extractions
DATA COLLECTION PROCEDURE
After obtaining an approval from the Ethical Review Committee and taking informed consent and informed assent from the parents and child respectively these patients will be recruited in the study as participants Patients visiting the orthodontic clinic at the Aga Khan University Hospital Karachi will be included in this study Detailed information regarding the study will be provided to the participants and they will be given the choice to either accept or refuse their inclusion in the study After the extraction of all first premolars under local anesthesia 0018 stainless steel archwires will be inserted in the maxillary and mandibular arches For canine retraction Ni-Ti closed-coil springs and elastomeric power chains will be randomly allocated to the right and left quadrants of both arches Radiographic measurement root resorption and clinical measurements canine retraction plaque accumulation and gingival health will be recorded at four points in time First at the start of the canine retraction T0 after first month T1 second month T2 and third month follow-up T3 Canine retraction rate will be recorded by using a 100 mm marked scale Data will be collected on an organized study proforma
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None