Orthodontic Appliances, Adverse Effects,Gingivitis, Dental Plaque, Periodontal Diseases
Conditions
Keywords
CAD/CAM manufacturing; orthodontic bands; periodontal health; digital dentistry; stainless steel biomaterials; orthodontic appliances
Brief summary
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.
Detailed description
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.
Interventions
DEVICEStainless-Steel Orthodontic Molar Bands
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.
Sponsors
Dimitrie Cantemir University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The orthodontist placing the molar bands was not blinded due to the nature of the interventions. However, periodontal measurements were performed by a calibrated examiner who was blinded to group allocation to reduce measurement bias.
Intervention model description
Participants were randomly assigned to receive either CAD/CAM-customized orthodontic molar bands or conventional preformed stainless-steel molar bands. Both groups underwent fixed orthodontic treatment, and periodontal outcomes were evaluated over a six-month follow-up period.
Eligibility
Sex/Gender
ALL
Age
9 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Plaque Control Record (PCR) between CAD/CAM-customized molar bands and standard stainless-steel molar bands | Baseline, 1 month, 3 months, and 6 months | Plaque Control Record (PCR) assessed on molar surfaces to evaluate plaque accumulation during orthodontic treatment. |
Countries
Romania
Outcome results
None listed