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OpenTrials
Completed

NCT Number: NCT07526805

Digital Manufacturing and Periodontal Performance of CAD/CAM-Customized Orthodontic Molar Bands Compared With Standard Stainless-Steel Bands

his prospective randomized clinical trial aimed to compare periodontal outcomes associated with CAD/CAM-customized orthodontic molar bands and conventional preformed stainless-steel molar bands in adolescents undergoing fixed orthodontic treatment. A total of 180 participants were randomly allocated into two groups: customized CAD/CAM bands (n = 90) and standard stainless-steel bands (n = 90). Periodontal parameters, including Plaque Control Record (PCR), Bleeding on Probing (BOP), and Periodontal Probing Depth (PPD), were evaluated at baseline, 1 month, 3 months, and 6 months. The primary objective was to assess whether customized bands improve periodontal health by reducing plaque accumulation and gingival inflammation during orthodontic therapy.

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Key information

Age range

9 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sorana-Maria Bucur

Târgu Mureş, Romania, 540545

About this study

Orthodontic molar bands are commonly fabricated from stainless-steel alloys and are widely used in fixed orthodontic therapy to provide anchorage for auxiliary appliances. However, conventional prefabricated bands are manufactured in standardized sizes and may not precisely adapt to individual tooth morphology. Inadequate adaptation may create plaque-retentive areas at the band-tooth interface, increasing the risk of gingival inflammation and early periodontal changes during orthodontic treatment.

Advances in digital dentistry have enabled the fabrication of customized orthodontic components using computer-aided design and computer-aided manufacturing (CAD/CAM) technologies. Digitally manufactured molar bands can be designed based on intraoral scans to achieve precise anatomical adaptation, potentially reducing marginal discrepancies and improving periodontal compatibility.

This prospective randomized controlled clinical study enrolled 180 adolescents requiring fixed orthodontic therapy involving molar bands. Participants were randomly assigned to receive either CAD/CAM-customized molar bands or conventional preformed stainless-steel molar bands. Customized bands were designed using digital intraoral scans and CAD software, then manufactured from cobalt-chromium alloy using high-precision milling and thermal sintering. Standard bands were selected from conventional size kits and manually adapted.

All bands were cemented using the same glass ionomer cement, and identical orthodontic appliances were used in both groups. Periodontal outcomes were assessed by a blinded examiner using standardized indices: Plaque Control Record (PCR), Bleeding on Probing (BOP), and Periodontal Probing Depth (PPD). Measurements were recorded at baseline, 1 month, 3 months, and 6 months.

The primary objective of the study was to evaluate differences in periodontal health between customized and conventional molar bands. Secondary objectives included assessing changes in plaque accumulation, gingival bleeding, and probing depth over time.

The study hypothesis was that CAD/CAM-customized molar bands would provide superior periodontal performance compared with standard stainless-steel bands due to improved anatomical adaptation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adolescents requiring fixed orthodontic therapy involving molar bands Good general health with no systemic diseases affecting periodontal tissues Acceptable baseline oral hygiene Patient and guardian consent to participate Compliance with follow-up visits

Exclusion criteria

History of periodontal disease Current antibiotic or anti-inflammatory therapy Dental trauma affecting first molars Poor oral hygiene compliance during screening Systemic conditions affecting periodontal health

Treatment and study plan

Stainless-Steel Orthodontic Molar Bands

Device

Patient-specific orthodontic molar bands fabricated using digital intraoral scanning, CAD software design, and CAD/CAM manufacturing from cobalt-chromium alloy to achieve precise anatomical adaptation.

Primary outcomes

  1. Change in Plaque Control Record (PCR) between CAD/CAM-customized molar bands and standard stainless-steel molar bands

    Time frame: Baseline, 1 month, 3 months, and 6 months

    Plaque Control Record (PCR) assessed on molar surfaces to evaluate plaque accumulation during orthodontic treatment.

Sponsors and collaborators

Lead sponsor

Dimitrie Cantemir University

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 13, 2026
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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