This RCT Compares the Clinical Performance, Stability, and Patient Perception of Different Diameters Orthodontic Miniscrews in the Posterior Maxilla Buccal Side.

NCT07868705 | Enrolling By Invitation DMC

• 1 other identifier: JEP20251230
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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.

  From miniscrew placement to 6 months, with assessments immediately after placement and at months 1, 2, 3, 4, 5, and 6.

Other Outcomes (3)

• Gingival inflammation around the miniscrew

  Immediately after miniscrew placement and at months 1, 2, 3, 4, 5, and 6.

• Maxillary sinus perforation assessed using CBCT

  Immediately after miniscrew placement (T0) and 6 months after placement (T6).

• Patient-reported questionnaire

  immediately after placement and monthly through 6 months.

Study Arms (2)

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.

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.

Device: Orthodontic miniscrew, 1.6-mm diameter and 8-mm length

Interventions

Orthodontic miniscrew, 1.3-mm diameter and 8-mm length DEVICE

-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, 1.3-mm diameter and 8-mm length

Orthodontic miniscrew, 1.6-mm diameter and 8-mm length DEVICE

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, 1.6-mm diameter and 8-mm length

Eligibility Criteria

• Age: 13 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \- 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National University of Malaysia: lead

Study Sites (1)

Universiti Kebangsaan Malaysia, Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur, Malaysia

Kuala Lumpur, 53000, Malaysia

Location

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The treating clinician will not be blinded to treatment allocation. The clinician responsible for orthodontic miniscrew placement will be aware of whether each participant receives a miniscrew measuring 1.3 mm or 1.6 mm in diameter.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2026
• First Posted: October 9, 2026
• Study Start: April 15, 2026
• Primary Completion: September 30, 2026
• Study Completion (Estimated): January 31, 2028
• Last Updated: October 9, 2026

Record last verified: 2026-10

Locations

MY (1)