NCT Number: NCT06567730
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).
Trial opening soon.
Get Notified13 year–40 year
All sexes
Interventional
Not applicable
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, 0.018" 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
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Ni-Ti closed-coil spring is a passive compressed spring made up of super elastic Nickel-titanium. Two eyelets are attached to each side of the coil to facilitate its application. The eyelets will be engaged in the hooks of the second premolar and canine brackets and will apply a force of 150 gm.
Other names: closing coil, closing coil spring
Elastomeric power chains are resilient and latex-free orthodontic materials. They are made up of elastic material and consist of many connected rings. Each ring is engaged in a bracket to apply a force of 175-300 gm.
Other names: Power chain
Time frame: 3 months
The retraction rate of canine will be the distance travelled divided by the time interval needed for closure of spaces. It will be noted at four-time intervals i.e at the start of the canine retraction (T0), after first month (T1), second month (T2) and third month follow-up (T3).
Time frame: 3 months
Root resorption is a decrease in root length and width due to an inflammatory process. In orthodontics, during tooth movement, areas of necrosis develop called hyalinized areas, which result in root resorption. Periapical radiographs will be taken to assess the amount of root resorption by determining the length of the tooth from the cusp tip to the root apex
Time frame: 3 months
Gingival index is a grading system that is used to assess the health of the gingiva. It consists of four grades including, Grade 0, 1, 2 and 3. The increase in grade indicates the compromised gingival health of the teeth.
Time frame: 3 months
Plaque index is a grading system used to assess the amount of plaque present at the gingival margins and helps in assessing oral health. It consists of four grades including, Grade 0, 1, 2 and 3. The increase in grade indicates the increased amount of plaque along the gingiva.
Contact information is provided by the study sponsor or research team.
Mubassar Fida, BDS,FCPS
CONTACT
Munnal Gulzar, BDS
CONTACT
Munnal Gulzar
Other
Comprehensive Comparison of Canine Retraction Using Nickel-titanium Closed-coil Springs Versus Elastomeric Power Chains During Orthodontic Treatment - A Split-mouth Randomized Controlled
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06847880
Biomarkers, Pain Perception
Baghdad, Baghdad Governorate, Iraq
View Trial DetailsNCT06199674
Orthodontics, Root Resorption
Hong Kong
View Trial DetailsNCT07566676
Deep Bite Malocclusion, Intrusion of Tooth
Cairo, Nasr City, Egypt
View Trial DetailsNCT07276984
Agnosia, Nervous System Diseases
Ho Chi Minh City, Vietnam
View Trial Details