Orthodontic Miniscrew SurvivalRCTNCT07868705
This RCT Compares the Clinical Performance, Stability, and Patient Perception of Different Diameters Orthodontic Miniscrews in the Posterior Maxilla Buccal Side.
A study testing Orthodontic miniscrew, 1.3-mm diameter and 8-mm length and Orthodontic miniscrew, 1.6-mm diameter and 8-mm length in people with Orthodontic Miniscrew Survival and Malocclusion, run by National University of Malaysia at 1 site in Malaysia.
Trial summary
Researchers will compare miniscrews with diameters of 1.3 millimeters and 1.6 millimeters. Both sizes are 8 millimeters long and will be placed between the roots of the first and second molar teeth at the back of the upper jaw. Participants will be assigned by chance to one of the two groups. Read more about this study
- Who is it for?
- Ages 13 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Miniscrew Survival, Malocclusion
- What is being tested?
- Orthodontic miniscrew, 1.3-mm diameter and 8-mm length and Orthodontic miniscrew, 1.6-mm diameter and 8-mm length
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteMalaysia
- Study dates
- 15 Apr 2026to 31 Jan 2028
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Non-smoker Age 13 to 50 years old Good oral hygiene
- Class II Division 1 Malocclusion patients who:
- Need moderate to high anchorage cases Half-unit to full-unit class II molar relationship Quarter or half-unit class II canine relationship Overjet of more than 6mm Patients who have extraction of maxillary first premolars Patients who are willing to participate in this study.
Who cannot join
- Pre-existing pathology in the maxillary buccal alveolar process where OMs are to be placed.
- Pre-existing chronic sinusitis Pre-existing pulpal or periodontal pathology in the maxillary posterior region. Systemic diseases which can affect maxillary and mandibular bone quality such as osteoporosis.
- Patients who require orthognathic surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Malaysia1 site
Universiti Kebangsaan Malaysia, Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur, Malaysia
Kuala Lumpur, 53000
About this study
Official title: Clinical Performance and Patient's Perception of Different Diameters Orthodontic Miniscrews Inserted at Posterior Maxillary Buccal Region: A Randomized Controlled Trial
Researchers will compare miniscrews with diameters of 1.3 millimeters and 1.6 millimeters. Both sizes are 8 millimeters long and will be placed between the roots of the first and second molar teeth at the back of the upper jaw. Participants will be assigned by chance to one of the two groups.
Participants will:
- Have miniscrews of their assigned size placed as part of their treatment with braces.
- Have the miniscrews and surrounding gums checked after placement and at monthly orthodontic appointments for six months.
- Complete questionnaires immediately after placement and at monthly appointments for six months to report pain, chewing difficulties, food getting trapped around the miniscrews, and avoidance of smiling.
- Conditions
- Orthodontic Miniscrew Survival, Malocclusion
- Being tested
- Orthodontic miniscrew, 1.3-mm diameter and 8-mm length, Orthodontic miniscrew, 1.6-mm diameter and 8-mm length
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orthodontic miniscrew, 1.3-mm diameter and 8-mm lengthDevice
-AbsoAnchor® power-head orthodontic miniscrews (Dentos, Daegu, South Korea), measuring 1.3 mm in diameter and 8 mm in length, will be inserted into the interradicular area between the maxillary first and second molars. The miniscrews will be used as part of fixed appliance orthodontic treatment in participants assigned to Group I.
Orthodontic miniscrew, 1.6-mm diameter and 8-mm lengthDevice
AbsoAnchor® power-head orthodontic miniscrews (Dentos, Daegu, South Korea), measuring 1.6 mm in diameter and 8 mm in length, will be inserted into the interradicular area between the maxillary first and second molars. The miniscrews will be used as part of fixed appliance orthodontic treatment in participants assigned to Group II.
| Study group | Role | What they receive |
|---|---|---|
| Orthodontic miniscrew, 1.3-mm diameter and 8-mm length | Experimental | Participants randomly assigned to Group I will receive AbsoAnchor® power-head orthodontic miniscrews (Dentos, Daegu, South Korea), measuring 1.3 mm in diameter and 8 mm in length. The miniscrews will be inserted into the interradicular area between the maxillary first and second molars as part of fixed appliance orthodontic treatment. Receives: Device: Orthodontic miniscrew, 1.3-mm diameter and 8-mm length |
| Orthodontic miniscrew, 1.6-mm diameter and 8-mm length | Active comparator | Participants randomly assigned to Group II will receive AbsoAnchor® power-head orthodontic miniscrews (Dentos, Daegu, South Korea), measuring 1.6 mm in diameter and 8 mm in length. The miniscrews will be inserted into the interradicular area between the maxillary first and second molars as part of fixed appliance orthodontic treatment. Receives: Device: Orthodontic miniscrew, 1.6-mm diameter and 8-mm length |
What is being measured
The primary outcome is the main question the study is designed to answer.
Orthodontic miniscrew survival at 6 months
Each miniscrew will be examined immediately after placement and at monthly orthodontic review appointments. A miniscrew that becomes loose, mobile, or fractured will be classified as a failure. Survival will be evaluated separately for the 1.3-mm and 1.6-mm diameter groups.
Measured: From miniscrew placement to 6 months, with assessments immediately after placement and at months 1, 2, 3, 4, 5, and 6.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start15 Apr 2026
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthodontic Miniscrew SurvivalStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07868705
- Sponsor's protocol ID
- JEP20251230
- Acronym
- RCT
- Status last verified
- Oct 2026
- First submitted
- 5 Oct 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: A decision on sharing de-identified individual participant data has not yet been made. Any future sharing would need to comply with participant consent, ethical approval, and institutional requirements.
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance and Patient's Perception of Different Diameters Orthodontic Miniscrews Inserted at Posterior Maxillary Buccal Region: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07868705
- Acronym / sponsor ID
- RCT / JEP20251230
- Conditions
- Orthodontic Miniscrew Survival, Malocclusion
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- National University of MalaysiaUniversity, hospital or other
- Study start
- 15 Apr 2026 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 9 Oct 2026 (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.
Researchers will compare miniscrews with diameters of 1.3 millimeters and 1.6 millimeters. Both sizes are 8 millimeters long and will be placed between the roots of the first and second molar teeth at the back of the upper jaw. Participants will be assigned by chance to one of the two groups.
Participants will:
- Have miniscrews of their assigned size placed as part of their treatment with braces.
- Have the miniscrews and surrounding gums checked after placement and at monthly orthodontic appointments for six months.
- Complete questionnaires immediately after placement and at monthly appointments for six months to report pain, chewing difficulties, food getting trapped around the miniscrews, and avoidance of smiling.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Orthodontic miniscrew, 1.3-mm diameter and 8-mm length | Experimental | Device: Orthodontic miniscrew, 1.3-mm diameter and 8-mm lengthParticipants randomly assigned to Group I will receive AbsoAnchor® power-head orthodontic miniscrews (Dentos, Daegu, South Korea), measuring 1.3 mm in diameter and 8 mm in length. The miniscrews will be inserted into the interradicular area between the maxillary first and second molars as part of fixed appliance orthodontic treatment. |
| Orthodontic miniscrew, 1.6-mm diameter and 8-mm length | Active comparator | Device: Orthodontic miniscrew, 1.6-mm diameter and 8-mm lengthParticipants randomly assigned to Group II will receive AbsoAnchor® power-head orthodontic miniscrews (Dentos, Daegu, South Korea), measuring 1.6 mm in diameter and 8 mm in length. The miniscrews will be inserted into the interradicular area between the maxillary first and second molars as part of fixed appliance orthodontic treatment. |
Who may qualify
- Ages
- 13 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Non-smoker Age 13 to 50 years old Good oral hygiene
- Need moderate to high anchorage cases Half-unit to full-unit class II molar relationship Quarter or half-unit class II canine relationship Overjet of more than 6mm Patients who have extraction of maxillary first premolars Patients who are willing to participate in this study.
Key exclusion criteria (3 listed)
- Pre-existing pathology in the maxillary buccal alveolar process where OMs are to be placed.
- Pre-existing chronic sinusitis Pre-existing pulpal or periodontal pathology in the maxillary posterior region. Systemic diseases which can affect maxillary and mandibular bone quality such as osteoporosis.
- Patients who require orthognathic surgery
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 |
|---|---|---|
| Orthodontic miniscrew, 1.3-mm diameter and 8-mm length-AbsoAnchor® power-head orthodontic miniscrews (Dentos, Daegu, South Korea), measuring 1.3 mm in diameter and 8 mm in length, will be inserted into the interradicular area between the maxillary first and second molars. The miniscrews will be used as part of fixed appliance orthodontic treatment in participants assigned to Group I. | Device | Orthodontic miniscrew, 1.3-mm diameter and 8-mm length |
| Orthodontic miniscrew, 1.6-mm diameter and 8-mm lengthAbsoAnchor® power-head orthodontic miniscrews (Dentos, Daegu, South Korea), measuring 1.6 mm in diameter and 8 mm in length, will be inserted into the interradicular area between the maxillary first and second molars. The miniscrews will be used as part of fixed appliance orthodontic treatment in participants assigned to Group II. | Device | Orthodontic miniscrew, 1.6-mm diameter and 8-mm length |
Primary outcome
Orthodontic miniscrew survival at 6 months
Time frame: From miniscrew placement to 6 months, with assessments immediately after placement and at months 1, 2, 3, 4, 5, and 6.
Each miniscrew will be examined immediately after placement and at monthly orthodontic review appointments. A miniscrew that becomes loose, mobile, or fractured will be classified as a failure. Survival will be evaluated separately for the 1.3-mm and 1.6-mm diameter groups.
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 9 Oct 2026.
- Individual participant dataSharing planned: Undecided. A decision on sharing de-identified individual participant data has not yet been made. Any future sharing would need to comply with participant consent, ethical approval, and institutional requirements.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orthodontic miniscrew, 1.3-mm diameter and 8-mm length and Orthodontic miniscrew, 1.6-mm diameter and 8-mm length in people with Orthodontic Miniscrew Survival and Malocclusion, run by National University of Malaysia at 1 site in Malaysia.
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: enrolling by invitation, as of the sponsor's last update on 9 Oct 2026. 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 Malaysia. 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?
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?
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?
Orthodontic miniscrew survival at 6 months (time frame: From miniscrew placement to 6 months, with assessments immediately after placement and at months 1, 2, 3, 4, 5, and 6.). 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 9 Oct 2026.