Clinical Effectiveness of the Calcium Chloride (CaCl2) Surface- Treated Orthodontic Mini Implant (OMI)

NCT06607536 | Completed

• 1 other identifier: REC/09/2021 (FB/56)
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this split mouth, randomised control study was to compare the clinical effectiveness of surface treated Calcium Chloride orthodontic mini implant in orthodontic patients. The main question\[s\] it aimed to answer were: Does the clinical effectiveness based on overall stability in maximum insertion torque and maximum removal torque measurement vary between untreated surface OMI, treated surface OMI with acid etching only and treated surface OMI with acid etching and calcium chloride immersion?, Does the surface roughness of OMI surface post removal vary between untreated surface OMI, treated surface OMI with acid etching only and treated-surface MI with acid etching and calcium chloride immersion? Does the success rate vary between untreated surface OMI, treated surface OMI with acid etching only and treated surface OMI with acid etching and calcium chloride immersion?Does the oral health quality of life and pain vary between untreated surface OMI, treated surface OMI with acid etching only and treated surface OMI with acid etching and calcium chloride immersion? Participants who is eligible for the study , orthodontic patient requiring moderate to high anchorage will be allocated to 2 groups (Group 1 : calcium chloride and control, Group 2 : acid etch, and control) to be used during the orthodontic treatment. The intervention is calcium chloride; the Calcium Chloride, positive control is the acid-etched and control is the machined group OMI. Comparison of the maximum insertion and removal torque, oral health quality of life, success rate and the surface roughness between the different groups of OMI.

Conditions

Basic Science; Orthodontic Appliance Complication; Malocclusion

Keywords

orthodontic mini implant; surface treated; anchorage; orthodontics

Outcome Measures

Primary Outcomes (1)

• Maximum insertion torque and removal torque

  Measurement of torque during insertion and removal of the mini implant. The higher the Ncm value, the higher is the stability of the mini implant. The values are directly proportionate to the stability.

  During procedure

Secondary Outcomes (3)

• Oral Health Quality of Life

  During procedure

• The surface roughness characteristics of the mini implant

  at the end of the study at 12 months

• Success rate of mini implant

  From enrolment to 6 months

Study Arms (3)

Calcium Chloride

EXPERIMENTAL

Mini implant immersed in the calcium chloride 0.1M solution

Other: calcium chloride surface treatment in mini implant

Acid Etch

ACTIVE COMPARATOR

mini implant etched with hydrochloric acid

Other: Acid Etched

machined mini implant

NO INTERVENTION

non surface treated mini implant

Interventions

calcium chloride surface treatment in mini implant OTHER

0.1M of Calcium Chloride were used to immersed the orthodontic mini implant

Calcium Chloride

Acid Etched OTHER

Mini implant etched in Hydrochloric acid

Acid Etch

Eligibility Criteria

• Age: 18 Years - 40 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age range between 18 and 40 years
• Good oral hygiene1
• Patients prescribed with fixed appliance who require extraction of at least one premolar at each quadrant.
• Moderate anchorage demand criteria
• Class II/1 incisor relationship

You may not qualify if:

• History of previous orthodontic treatment
• Patient who requires combination of orthodontic and orthognathic surgery
• Medically compromised2 or patients who is taking any medication that interferes with bone metabolism.
• Presence of craniofacial syndromes or clefts
• Active periodontal disease
• Poor oral hygiene prior to orthodontic treatment
• Smoking3

Sponsors & Collaborators

• Universiti Teknologi Mara: lead
• Ministry of Health, Malaysia: collaborator

Study Sites (1)

University Technology Mara Malaysia

Sungai Buloh, Selangor, 47000, Malaysia

Location

MeSH Terms

Conditions

Malocclusion

Interventions

Denture, Partial, Fixed, Resin-Bonded

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Denture, Partial, Fixed; Denture, Partial; Dentures; Dental Prosthesis; Prosthodontics; Dentistry; Prostheses and Implants; Equipment and Supplies

Study Officials

• MARYATI MD DASOR

  UNIVERSITY TECHNOLOGY MARA MALAYSIA

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: sealed envelop
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: 3 arm parallel, split mouth

Study Record Dates

• First Submitted: September 17, 2024
• First Posted: September 23, 2024
• Study Start: January 9, 2023
• Primary Completion: March 29, 2024
• Study Completion: March 29, 2024
• Last Updated: September 23, 2024

Record last verified: 2024-09

Locations

MY (1)