An interventional study of Orthodontic miniscrew, 1.3-mm diameter and 8-mm length and Orthodontic miniscrew, 1.6-mm diameter and 8-mm length in Orthodontic Miniscrew Survival and Malocclusion, sponsored by National University of Malaysia. Enrolling by invitation at 1 site in Malaysia. Open to participants aged 13 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-09.
Sponsored by National University of Malaysia · Not applicable, Interventional, and Treatment
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:
469 studies on the registry are indexed under Malocclusion; 91 are open to participants now.
This study's planned enrollment of 38 is close to the median of 36 across 383 interventional studies indexed under Malocclusion.
Browse Malocclusion studies →National University of Malaysia is the lead sponsor of 124 studies on the registry; 45 are open to participants now.
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- 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.
Exclusion Criteria:
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
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.
Device: Orthodontic miniscrew, 1.3-mm diameter and 8-mm length
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.
Device: Orthodontic miniscrew, 1.6-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.
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.
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.
Time frame: From miniscrew placement to 6 months, with assessments immediately after placement and at months 1, 2, 3, 4, 5, and 6.
Gingival inflammation around the miniscrew
Gingival inflammation surrounding each orthodontic miniscrew will be assessed by visual inspection and probing using the protocol-specified gingival index. Scores range from 0 to 3: 0 indicates no inflammation; 1 indicates mild inflammation without bleeding on probing; 2 indicates moderate inflammation with bleeding on probing; and 3 indicates severe inflammation with a tendency towards spontaneous bleeding. Higher scores indicate more severe gingival inflammation.
Time frame: Immediately after miniscrew placement and at months 1, 2, 3, 4, 5, and 6.
Maxillary sinus perforation assessed using CBCT
Maxillary sinus perforation associated with orthodontic miniscrew placement will be assessed using cone-beam computed tomography (CBCT). Perforation will be recorded as present or absent for each miniscrew. The percentage of miniscrews showing maxillary sinus perforation will be evaluated separately for the 1.3-mm and 1.6-mm diameter groups at each assessment.
Time frame: Immediately after miniscrew placement (T0) and 6 months after placement (T6).
Patient-reported questionnaire
A modified questionnaire assessing pain, difficulty chewing, food impaction, and avoidance of smiling.
Time frame: immediately after placement and monthly through 6 months.
Plan to share: 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.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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