En-masse Retraction to Two- Steps RetractionNCT05963438
Comparison Of En-Masse Retraction With Two-Step Retraction Using Mini-Implant As Anchorage
A study testing anterior retraction in people with En-masse Retraction to Two- Steps Retraction, run by Dow University of Health Sciences at 1 site in Pakistan.
Trial summary
This Randomized Control Trial will be conducted to compare the effects of en-masse retraction to two- steps retraction on sagittal, vertical and dental dimensions using mini-implant as anchorage. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- En-masse Retraction to Two- Steps Retraction
- What is being tested?
- anterior retraction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Oct 2022to 4 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1. Both male and female patients with age of 18- 25 years. 2. Cases treated with upper first premolars extractions. 3. Cases having class II molar relation which is mesiobuccal cusp of maxillary first permanent molar occludes anterior to the buccal groove of mandibular first molar on both sides as assessed clinically.
- 4. Overjet > 5mm and < 12mm as assessed clinically. 5. Cases with no remaining growth as assessed by cervical vertebrae maturation stages (cvm) ≥4 on lateral cephalometric radiograph .
- 6. Cases with no congenitally missing teeth (excluding third molars).
Who cannot join
- 1. Long term use of systemic corticosteroids, calcium channel blockers \& anti-inflammatory drugs.
- 2. Cases with syndromes like cleft lip and palate as assessed clinically. 3. Cases in which active growth is still taking place as assessed by cervical vertebrae maturation stages (cvm) ≤ 3 on lateral cephalometric radiograph.
- 4. Radiographic evidence of bone loss. 5. Periodontal disease as assessed clinically.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Of En-Masse Retraction With Two-Step Retraction Using Mini-Implant As Anchorage - A Randomized Controlled Trial
This Randomized Control Trial will be conducted to compare the effects of en-masse retraction to two- steps retraction on sagittal, vertical and dental dimensions using mini-implant as anchorage.
Read the detailed description
Extractions of teeth are the commonest approach in treating orthodontic problems. There is several extraction protocol commonly employed in the orthodontic correction of class II malocclusion ranging from the extraction of two premolars (20.2%) to four premolars (42.9%).
Retraction of anterior teeth followed by the extraction of premolars requires anchorage to restrict the mesial movement of posterior teeth. Anchorage control is a major factor in achieving successful orthodontic treatment and it can be achieved by variety of appliances, of which titanium screws have been considered as an absolute source of anchorage in orthodontics treatment. The anchorage reinforced from mini-implant is helpful in minimizing anchorage loss and accepted heavy traction forces.
Retraction of anterior teeth can be achieved either by en-masse retraction, moving all the six anterior teeth together in a single step or by two-step retraction, separately retract canines in first step followed by retracting the four anteriors in the second step.
This Randomized Control Trial will be conducted to compare the effects of en-masse retraction to two- steps retraction on sagittal, vertical and dental dimensions using mini-implant as anchorage. 80 patients will be included in this study after meeting the eligibility criteria. Each group will contain 40 patients.
The patients will be divided in two groups i.e. two-step retraction group (control group) and en-masse group (experimental group), through software generated randomization table.
Two-step retraction group (control group) In this group, immediately after placement of mini-implant and extractions of upper first premolars, heavy ligation will be done from mini-implant to maxillary second premolar and first molar. Canine will be retracted by sliding mechanics and the four anterior teeth will be retracted by loop mechanics. Loops will be activated every three weeks by 1 mm.
Retraction will be stopped when canines establish class I relationship and a good incisor relationship will be obtained in both the groups
En-masse retraction group(experimental group) After placement of mini-implants and extraction of maxillary first premolar, rectangular stainless steel arch wire with anterior 8mm height crimpable hooks distal to the lateral incisors will be inserted and force will be applied using elastic chains attached between the mini-implant and the hooks for conducting en-masse retraction. Elastic chains will replace after every three weeks.
Pretreatment lateral cepalogram will be taken at time of enrolment (T1) and post-treatment lateral cephalogram taken after 12 months of orthodontic treatment (T2). All cephalometric radiograph will be traced on acetate tracing sheets 0.5 μm in thickness using a sharp 4H pencil on a view box using transilluminated light in a dark room.
The analysis will be done on pretreatment cephalogram (T1) and post treatment lateral cephalogram (T2) and then their measurements will be compared to find out changes in the sagittal, vertical and dental dimensions.
- Being tested
- anterior retraction
- Keywords
- En-masse retraction, Two step retraction, mini-implant, anchorage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anterior retractionProcedure or surgery
After placement of mini-implants and extraction of maxillary first premolar, retraction of anterior either simultaneously or separately depending on the allocated group will be done
| Study group | Role | What they receive |
|---|---|---|
| Two-step retraction group (control group) | Other | In this group, immediately after placement of mini-implant and extractions of upper first premolars, heavy ligation will be done from mini-implant to maxillary second premolar and first molar. Canine will be retracted by sliding mechanics and the four anterior teeth will be retracted by loop mechanics. Loops will be activated every three weeks by 1 mm. Receives: Procedure: anterior retraction |
| En-masse retraction group(experimental group) | Experimental | After placement of mini-implants and extraction of maxillary first premolar, rectangular stainless steel arch wire with anterior 8mm height crimpable hooks distal to the lateral incisors will be inserted and force will be applied using elastic chains attached between the mini-implant and the hooks for conducting en-masse retraction. Elastic chains will replace after every three weeks Receives: Procedure: anterior retraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare sagittal, vertical and dental dimensions following en-masse retraction with two-step retraction using mini-implants as anchorage.
Measured: Pretreatment lateral cepalogram will be taken at time of enrolment (T1) and post-treatment lateral cephalogram taken after 12 months of orthodontic treatment (T2).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start10 Oct 2022
- Primary completion4 Jun 2024
- Study completion4 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for En-masse Retraction to Two- Steps RetractionStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anam Sattar, Dow University of Health Sciences
- Investigators
- Anam Sattar, FCPS, Principal investigator, Dow University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05963438
- Sponsor's protocol ID
- 2681
- Status last verified
- Feb 2024
- First submitted
- 19 Jul 2023
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: sagittal, vertical and dental dimensions following en-masse retraction with two-step retraction will be compared using mini-implants as anchorage
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of En-Masse Retraction With Two-Step Retraction Using Mini-Implant As Anchorage - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05963438
- Acronym / sponsor ID
- 2681
- Keywords
- En-masse retraction, Two step retraction, mini-implant, anchorage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 10 Oct 2022 (actual)
- Primary completion
- 4 Jun 2024 (actual)
- Study completion
- 4 Jun 2024 (actual)
- First posted
- 27 Jul 2023 (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.
This Randomized Control Trial will be conducted to compare the effects of en-masse retraction to two- steps retraction on sagittal, vertical and dental dimensions using mini-implant as anchorage.
Detailed description
Extractions of teeth are the commonest approach in treating orthodontic problems. There is several extraction protocol commonly employed in the orthodontic correction of class II malocclusion ranging from the extraction of two premolars (20.2%) to four premolars (42.9%).
Retraction of anterior teeth followed by the extraction of premolars requires anchorage to restrict the mesial movement of posterior teeth. Anchorage control is a major factor in achieving successful orthodontic treatment and it can be achieved by variety of appliances, of which titanium screws have been considered as an absolute source of anchorage in orthodontics treatment. The anchorage reinforced from mini-implant is helpful in minimizing anchorage loss and accepted heavy traction forces.
Retraction of anterior teeth can be achieved either by en-masse retraction, moving all the six anterior teeth together in a single step or by two-step retraction, separately retract canines in first step followed by retracting the four anteriors in the second step.
This Randomized Control Trial will be conducted to compare the effects of en-masse retraction to two- steps retraction on sagittal, vertical and dental dimensions using mini-implant as anchorage. 80 patients will be included in this study after meeting the eligibility criteria. Each group will contain 40 patients.
The patients will be divided in two groups i.e. two-step retraction group (control group) and en-masse group (experimental group), through software generated randomization table.
Two-step retraction group (control group) In this group, immediately after placement of mini-implant and extractions of upper first premolars, heavy ligation will be done from mini-implant to maxillary second premolar and first molar. Canine will be retracted by sliding mechanics and the four anterior teeth will be retracted by loop mechanics. Loops will be activated every three weeks by 1 mm.
Retraction will be stopped when canines establish class I relationship and a good incisor relationship will be obtained in both the groups
En-masse retraction group(experimental group) After placement of mini-implants and extraction of maxillary first premolar, rectangular stainless steel arch wire with anterior 8mm height crimpable hooks distal to the lateral incisors will be inserted and force will be applied using elastic chains attached between the mini-implant and the hooks for conducting en-masse retraction. Elastic chains will replace after every three weeks.
Pretreatment lateral cepalogram will be taken at time of enrolment (T1) and post-treatment lateral cephalogram taken after 12 months of orthodontic treatment (T2). All cephalometric radiograph will be traced on acetate tracing sheets 0.5 μm in thickness using a sharp 4H pencil on a view box using transilluminated light in a dark room.
The analysis will be done on pretreatment cephalogram (T1) and post treatment lateral cephalogram (T2) and then their measurements will be compared to find out changes in the sagittal, vertical and dental dimensions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Two-step retraction group (control group) | Other | Procedure: anterior retractionIn this group, immediately after placement of mini-implant and extractions of upper first premolars, heavy ligation will be done from mini-implant to maxillary second premolar and first molar. Canine will be retracted by sliding mechanics and the four anterior teeth will be retracted by loop mechanics. Loops will be activated every three weeks by 1 mm. |
| En-masse retraction group(experimental group) | Experimental | Procedure: anterior retractionAfter placement of mini-implants and extraction of maxillary first premolar, rectangular stainless steel arch wire with anterior 8mm height crimpable hooks distal to the lateral incisors will be inserted and force will be applied using elastic chains attached between the mini-implant and the hooks for conducting en-masse retraction. Elastic chains will replace after every three weeks |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 1. Both male and female patients with age of 18- 25 years. 2. Cases treated with upper first premolars extractions. 3. Cases having class II molar relation which is mesiobuccal cusp of maxillary first permanent molar occludes anterior to the buccal groove of mandibular first molar on both sides as assessed clinically.
- 4. Overjet > 5mm and < 12mm as assessed clinically. 5. Cases with no remaining growth as assessed by cervical vertebrae maturation stages (cvm) ≥4 on lateral cephalometric radiograph .
- 6. Cases with no congenitally missing teeth (excluding third molars).
Key exclusion criteria (3 listed)
- 1. Long term use of systemic corticosteroids, calcium channel blockers \& anti-inflammatory drugs.
- 2. Cases with syndromes like cleft lip and palate as assessed clinically. 3. Cases in which active growth is still taking place as assessed by cervical vertebrae maturation stages (cvm) ≤ 3 on lateral cephalometric radiograph.
- 4. Radiographic evidence of bone loss. 5. Periodontal disease as assessed clinically.
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 |
|---|---|---|
| anterior retractionAfter placement of mini-implants and extraction of maxillary first premolar, retraction of anterior either simultaneously or separately depending on the allocated group will be done | Procedure or surgery | En-masse retraction group(experimental group), Two-step retraction group (control group) |
Primary outcome
To compare sagittal, vertical and dental dimensions following en-masse retraction with two-step retraction using mini-implants as anchorage.
Time frame: Pretreatment lateral cepalogram will be taken at time of enrolment (T1) and post-treatment lateral cephalogram taken after 12 months of orthodontic treatment (T2).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Individual participant dataSharing planned: Yes. sagittal, vertical and dental dimensions following en-masse retraction with two-step retraction will be compared using mini-implants as anchorage
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. This study is not recruiting at the moment.
Anam Sattar, FCPS principal investigator
Dow University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing anterior retraction in people with En-masse Retraction to Two- Steps Retraction, run by Dow University of Health Sciences at 1 site in Pakistan.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare sagittal, vertical and dental dimensions following en-masse retraction with two-step retraction using mini-implants as anchorage. (time frame: Pretreatment lateral cepalogram will be taken at time of enrolment (T1) and post-treatment lateral cephalogram taken after 12 months of orthodontic treatment (T2).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Sep 2025.