Root ResorptionNCT06567730
Comparison of Canine Retraction Using Ni-ti Closed-coil Springs Vs Elastomeric Power Chains During Orthodontic Treatment
A study testing Ni-ti Closed-coil Spring and Elastomeric Power chain in people with Root Resorption and Plaque Accumulation, run by Munnal Gulzar.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Root Resorption, Plaque Accumulation, Gingivitis
- What is being tested?
- Ni-ti Closed-coil Spring and Elastomeric Power chain
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- Mar 2025to Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients aged between 13 - 40 years
- Patients undergoing fixed orthodontic treatment
- Patients requiring all first premolars extraction as part of orthodontic treatment
- Patients with all permanent teeth present and erupted (except for second and third molars)
- All patients who will sign the informed consent/assent form
Who cannot join
- • Patients with systemic diseases that can affect tooth movements
- Patients with uncontrolled periodontal disease
- Patients with craniofacial syndromes
- Pregnant or lactating mothers
- Patients with bracket failures greater than three times per bracket during the study
- Patients on medications that can affect tooth movements
- Patients with Nickel allergy
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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).
Read the 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, 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
- Conditions
- Root Resorption, Plaque Accumulation, Gingivitis
- Being tested
- Ni-ti Closed-coil Spring, Elastomeric Power chain
- Keywords
- canine retraction rate
- Medical subject headings
- Root Resorption, Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ni-ti Closed-coil SpringOther
Also called closing coil, closing coil spring
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.
Elastomeric Power chainOther
Also called Power chain
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.
| Study group | Role | What they receive |
|---|---|---|
| Ni-ti closed Coil spring | Experimental | For canine retraction, Ni-Ti closed-coil springs will be randomly allocated to the right and left quadrants of both arches Receives: Other: Ni-ti Closed-coil Spring |
| Elastomeric power chain | Active comparator | For canine retraction, elastomeric power chains will be randomly allocated to the right and left quadrants of both arches Receives: Other: Elastomeric Power chain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Canine retraction rate
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).
Measured: 3 months
Secondary outcomes (3)
Root resorption
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
Measured: 3 months
Gingival health
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.
Measured: 3 months
Plaque index
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2024
- Study startMar 2025 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Root ResorptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Munnal Gulzar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Munnal Gulzar, Aga Khan University Hospital, Pakistan
- Investigators
- Mubassar Fida, BDS,FCPS, Principal investigator, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06567730
- Sponsor's protocol ID
- 2024-9110-28139
- Status last verified
- Jan 2025
- First submitted
- 16 Aug 2024
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wazwaz F, Seehra J, Carpenter GH, Papageorgiou SN, Cobourne MT. Duration of canine retraction with fixed appliances: A systematic review and meta-analysis. Am J Orthod Dentofacial Orthop. 2023 Feb;163(2):154-172. doi: 10.1016/j.ajodo.2022.08.009. Epub 2022 Dec 1.
PubMed 36464569Kulshrestha RS, Tandon R, Chandra P. Canine retraction: A systematic review of different methods used. J Orthod Sci. 2015 Jan-Mar;4(1):1-8. doi: 10.4103/2278-0203.149608.
PubMed 25657985Makhlouf M, Aboul-Ezz A, Fayed MS, Hafez H. Evaluating the Amount of Tooth Movement and Root Resorption during Canine Retraction with Friction versus Frictionless Mechanics Using Cone Beam Computed Tomography. Open Access Maced J Med Sci. 2018 Feb 5;6(2):384-388. doi: 10.3889/oamjms.2018.066. eCollection 2018 Feb 15.
PubMed 29531610Gulzar M, Amin L, Ilyas R, Fida M, Sukhia RH. Comprehensive comparison of extraction space closure during canine retraction using nickel-titanium closed-coil springs versus elastomeric power chains during orthodontic treatment - a split-mouth randomized controlled trial. BMC Oral Health. 2026 Jun 22. doi: 10.1186/s12903-026-08932-0. Online ahead of print.
PubMed 42332649
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06567730
- Acronym / sponsor ID
- 2024-9110-28139
- Conditions
- Root Resorption, Plaque Accumulation, Gingivitis
- Keywords
- canine retraction rate
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Munnal GulzarUniversity, hospital or other
- Study start
- Mar 2025 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 23 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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, 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ni-ti closed Coil spring | Experimental | Other: Ni-ti Closed-coil SpringFor canine retraction, Ni-Ti closed-coil springs will be randomly allocated to the right and left quadrants of both arches |
| Elastomeric power chain | Active comparator | Other: Elastomeric Power chainFor canine retraction, elastomeric power chains will be randomly allocated to the right and left quadrants of both arches |
Who may qualify
- Ages
- 13 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Patients aged between 13 - 40 years
- Patients undergoing fixed orthodontic treatment
- Patients requiring all first premolars extraction as part of orthodontic treatment
- Patients with all permanent teeth present and erupted (except for second and third molars)
- All patients who will sign the informed consent/assent form
Key exclusion criteria (7 listed)
- • Patients with systemic diseases that can affect tooth movements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ni-ti Closed-coil SpringAlso: closing coil, closing coil springNi-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 | Ni-ti closed Coil spring |
| Elastomeric Power chainAlso: Power chainElastomeric 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 | Elastomeric power chain |
Primary outcome
Canine retraction rate
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).
3 secondary outcomes
Root resorption
Time frame: 3 months
Gingival health
Time frame: 3 months
Plaque index
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
- Background: PubMed 36464569Wazwaz F, Seehra J, Carpenter GH, Papageorgiou SN, Cobourne MT. Duration of canine retraction with fixed appliances: A systematic review and meta-analysis. Am J Orthod Dentofacial Orthop. 2023 Feb;163(2):154-172. doi: 10.1016/j.ajodo.2022.08.009. Epub 2022 Dec 1.
- Background: PubMed 25657985Kulshrestha RS, Tandon R, Chandra P. Canine retraction: A systematic review of different methods used. J Orthod Sci. 2015 Jan-Mar;4(1):1-8. doi: 10.4103/2278-0203.149608.
- Background: PubMed 29531610Makhlouf M, Aboul-Ezz A, Fayed MS, Hafez H. Evaluating the Amount of Tooth Movement and Root Resorption during Canine Retraction with Friction versus Frictionless Mechanics Using Cone Beam Computed Tomography. Open Access Maced J Med Sci. 2018 Feb 5;6(2):384-388. doi: 10.3889/oamjms.2018.066. eCollection 2018 Feb 15.
- Derived from this study: PubMed 42332649Gulzar M, Amin L, Ilyas R, Fida M, Sukhia RH. Comprehensive comparison of extraction space closure during canine retraction using nickel-titanium closed-coil springs versus elastomeric power chains during orthodontic treatment - a split-mouth randomized controlled trial. BMC Oral Health. 2026 Jun 22. doi: 10.1186/s12903-026-08932-0. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mubassar Fida, BDS,FCPS principal investigator
Aga Khan University
Questions about this trial
What is this clinical trial studying?
A study testing Ni-ti Closed-coil Spring and Elastomeric Power chain in people with Root Resorption and Plaque Accumulation, run by Munnal Gulzar.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Munnal Gulzar, BDS (03343536106, munnal.gulzar@aku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Canine retraction rate (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06567730, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2025.