Root ResorptionCBCTNCT05606185
Amount of Root Resorption of Maxillary Anteriors After en Masse Versus Two Step Space Closure
A study testing retraction method in people with Root Resorption, run by Dow University of Health Sciences at 1 site in Pakistan.
Trial summary
The goal of this study is to compare the three dimensional root resorption after extraction space closure in two groups: two step retraction and en masse retraction. Th main aim of this study is to conclude which method is less damaging to the roots. Participants will be divided into two groups: 1. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Root Resorption
- What is being tested?
- retraction method
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 9 Dec 2019to Nov 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients who signed the informed consent to be part of this study.
- Patients with Class I or Class II malocclusion.
- Patients requiring extractions of maxillary first premolars with absolute anchorage.
- Good periodontal status.
Who cannot join
- Patients who are syndromic or have cleft lip and/or palate.
- Patients with severe root dilacerations or root canal treated incisors.
- Patients receiving drugs that alter tooth movement.
- Patients with systemic disease like endocrinological disorders, vit D excess or deficiency, thyroid or parathyroid problems.
- Patients with history of trauma to dentition or impacted teeth in anterior maxilla.
- Patients who have undergone previous orthodontic treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Amount of Root Resorption of Maxillary Anteriors After en Masse Versus Two Step Space Closure Using Cone Beam Computed Tomography
The goal of this study is to compare the three dimensional root resorption after extraction space closure in two groups: two step retraction and en masse retraction. Th main aim of this study is to conclude which method is less damaging to the roots.
Participants will be divided into two groups:
- En masse retraction (experimental)
- Two step retraction (control) Pre retraction and post retraction CBCT scans will be compared for both groups.
- Conditions
- Root Resorption
- Being tested
- retraction method
- Keywords
- Two step retraction, En masse retraction, Cone Beam Computed Tomography
- Medical subject headings
- Root Resorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
retraction methodProcedure or surgery
Three dimensional evaluation of root resorption using cone beam computed tomography
| Study group | Role | What they receive |
|---|---|---|
| Two step retraction | Active comparator | teeth will be retracted in two stages Receives: Procedure: retraction method |
| En masse retraction | Experimental | teeth will be retracted in one stage Receives: Procedure: retraction method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Root resorption
Amount of root resorption in three dimensions
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2022
- Study start9 Dec 2019
- Primary completionNov 2022 (estimated)
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hiba Tabassum, Dow University of Health Sciences
- Investigators
- HIBA Tabassum, MDS, Principal investigator, Dow University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05606185
- Sponsor's protocol ID
- DUHS/BASR/2019/-509
- Acronym
- CBCT
- Status last verified
- Oct 2022
- First submitted
- 31 Oct 2022
- Last updated
- 4 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tabassum H, Ahmed I, Arshad S, Khan EB, Rizwan S, Hussain S. Comparison of external apical root resorption in maxillary anterior teeth following en-masse versus two-step retraction: a 3D volumetric CBCT-based randomized controlled trial. Clin Oral Investig. 2026 Aug 29;30(9):424. doi: 10.1007/s00784-026-07089-y.
PubMed 42667330
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amount of Root Resorption of Maxillary Anteriors After en Masse Versus Two Step Space Closure Using Cone Beam Computed Tomography
- ClinicalTrials.gov ID
- NCT05606185
- Acronym / sponsor ID
- CBCT / DUHS/BASR/2019/-509
- Conditions
- Root Resorption
- Keywords
- Two step retraction, En masse retraction, Cone Beam Computed Tomography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 9 Dec 2019 (actual)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 4 Nov 2022 (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 goal of this study is to compare the three dimensional root resorption after extraction space closure in two groups: two step retraction and en masse retraction. Th main aim of this study is to conclude which method is less damaging to the roots.
Participants will be divided into two groups:
- En masse retraction (experimental)
- Two step retraction (control) Pre retraction and post retraction CBCT scans will be compared for both groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Two step retraction | Active comparator | Procedure: retraction methodteeth will be retracted in two stages |
| En masse retraction | Experimental | Procedure: retraction methodteeth will be retracted in one stage |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who signed the informed consent to be part of this study.
- Patients with Class I or Class II malocclusion.
- Patients requiring extractions of maxillary first premolars with absolute anchorage.
- Good periodontal status.
Key exclusion criteria (6 listed)
- Patients who are syndromic or have cleft lip and/or palate.
- Patients with severe root dilacerations or root canal treated incisors.
- Patients receiving drugs that alter tooth movement.
- Patients with systemic disease like endocrinological disorders, vit D excess or deficiency, thyroid or parathyroid problems.
- Patients with history of trauma to dentition or impacted teeth in anterior maxilla.
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 |
|---|---|---|
| retraction methodThree dimensional evaluation of root resorption using cone beam computed tomography | Procedure or surgery | En masse retraction, Two step retraction |
Primary outcome
Root resorption
Time frame: 8 months
Amount of root resorption in three dimensions
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2022.
- Derived from this study: PubMed 42667330Tabassum H, Ahmed I, Arshad S, Khan EB, Rizwan S, Hussain S. Comparison of external apical root resorption in maxillary anterior teeth following en-masse versus two-step retraction: a 3D volumetric CBCT-based randomized controlled trial. Clin Oral Investig. 2026 Aug 29;30(9):424. doi: 10.1007/s00784-026-07089-y.
- 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. This study is not recruiting at the moment.
HIBA Tabassum, MDS 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 retraction method in people with Root Resorption, 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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 4 Nov 2022. 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?
Results are not available in the source record.
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?
Root resorption (time frame: 8 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 NCT05606185, which also lists 1 linked publication.
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 4 Nov 2022.