Evaluation of Two Mini-Implant Lengths in the Infra-Zygomatic Crest Region

NCT06293872 | Completed DMC

• 1 other identifier: IZC miniscrew
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluation of two different lengths of mini-implants in the infrazygomatic area regarding primary stability, pain perception, sinus penetration, secondary stability and failure rate.

Conditions

Orthodontic Appliance Complication

Keywords

mini-screws, infrazygomatic crest zone, IZC, orthodontics implant.

Outcome Measures

Primary Outcomes (1)

• failure rate

  the miniscrew regarded as failed if it is mobile and can not fulfill it is anchorage function, covered by soft tissue.

  6 months

Secondary Outcomes (3)

• primary stability

  immediately after placement

• secondary stability

  after 6months

• pain perception

  after 1st day and after 1st week

Study Arms (2)

12*2 mm length miniscrew

EXPERIMENTAL

The self-drilling screw is directed at 90° to the occlusal plane at this point. After the initial notch in the bone is created after couple of turns to the driver, the bone screw driver direction is changed by 55°-70° toward the tooth, downward, which aid in bypassing the roots of the teeth and directing the screw to the infra-zygomatic area of the maxilla. The bone screw is screwed until only the head of the screw is visible outside the alveolar mucosa. Follow-up: C.B.C.T will be performed after surgery to verify the implant position relative to the adjacent roots.

Device: 12*2 mm length miniscrew

14*2 mm length miniscrew

ACTIVE COMPARATOR

The self-drilling screw is directed at 90° to the occlusal plane at this point. After the initial notch in the bone is created after couple of turns to the driver, the bone screw driver direction is changed by 55°-70° toward the tooth, downward, which aid in bypassing the roots of the teeth and directing the screw to the infra-zygomatic area of the maxilla. The bone screw is screwed until only the head of the screw is visible outside the alveolar mucosa. Follow-up: C.B.C.T will be performed after surgery to verify the implant position relative to the adjacent roots.

Device: 12*2 mm length miniscrew

Interventions

12*2 mm length miniscrew DEVICE

Prior to mini-inplant insertion the patient will instructed to rinse mouth with chlorhexidine mouthwash, then local anesthesia will be applied. The clinical implication for miniscrew insertion in the IZ crest of adults is 14 to 16 mm above the maxillary occlusal plane and the maxillary first molar. The self-drilling screw is directed at 90° to the occlusal plane at this point. After the initial notch in the bone is created after couple of turns to the driver, the bone screw driver direction is changed by 55°-70° toward the tooth, downward, which aid in bypassing the roots of the teeth and directing the screw to the infra-zygomatic area of the maxilla. The bone screw is screwed until only the head of the screw is visible outside the alveolar mucosa. Follow-up: C.B.C.T will be performed after surgery to verify the implant position relative to the adjacent roots

Also known as: 14*2 mm length miniscrew

12*2 mm length miniscrew; 14*2 mm length miniscrew

Eligibility Criteria

• Age: 15 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \- a. Patients (age of patients is 15-50 y.) need metal fixed orthodontic treatment including placement of miniscrews.
• b. The position of mini-implant in upper buccal posterior area (infrazygomatic area).

You may not qualify if:

• If c.b.c.t show that the screw placed intraradicular will be excluded.
• Images suggesting sinus inflammation or pathology before mini-implant insertin.

Sponsors & Collaborators

• University of Baghdad: lead

Study Sites (1)

University of Baghdad College of Dentistry

Baghdad, 10011, Iraq

Location

Related Publications (1)

• Alsaeedi AF, Alrubayee MA, Sivamurthy G. Evaluation of Two Mini-implant Lengths in the Infrazygomatic Crest Region: A Randomized Clinical Trial. Eur J Dent. 2025 May;19(2):399-408. doi: 10.1055/s-0044-1789015. Epub 2024 Nov 7.

  PMID: 39510519 DERIVED

Study Officials

• Mehdi abd Alrubayee, B.D.S; M.Sc; PhD

  Assistant Professor, Department of Orthodontics, College of Dentistry, University of Baghdad, Iraq.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Bachelor's dental Surgery ( B. D. S)

Study Record Dates

• First Submitted: February 27, 2024
• First Posted: March 5, 2024
• Study Start: February 25, 2023
• Primary Completion: July 10, 2023
• Study Completion: December 28, 2023
• Last Updated: March 5, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 10/10/2024 for 3 months
• Access Criteria: I can provide data as word

Locations

IR (1)