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| ID | Type | Description | Link |
|---|---|---|---|
| Approval No. 2709/27.12.2023 | Registry Identifier | Dimitrie Cantemir Registry |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CAD/CAM-Customized Molar Bands | Experimental | ARM 1 Arm Description: Participants received CAD/CAM-customized orthodontic molar bands designed using digital intraoral scans and computer-aided design software. Bands were manufactured from cobalt-chromium alloy using high-precision milling and thermal sintering and cemented as part of fixed orthodontic treatment. Intervention: CAD/CAM-Customized Orthodontic Molar Bands |
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| Standard Stainless-Steel Molar Bands | Active Comparator | Participants received conventional preformed stainless-steel orthodontic molar bands selected from standard size kits and manually adapted before cementation as part of fixed orthodontic treatment. Intervention: Standard Stainless-Steel Orthodontic Molar Bands |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Plaque Control Record (PCR) between CAD/CAM-customized molar bands and standard stainless-steel molar bands | Plaque Control Record (PCR) assessed on molar surfaces to evaluate plaque accumulation during orthodontic treatment. | Baseline, 1 month, 3 months, and 6 months |
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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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sorana-Maria Bucur | Târgu Mureş | Romania | 540545 | Romania |
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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.
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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.
| ID | Term |
|---|---|
| D005891 | Gingivitis |
| D003773 | Dental Plaque |
| D010510 | Periodontal Diseases |
| ID | Term |
|---|---|
| D007239 | Infections |
| D005882 | Gingival Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D003741 | Dental Deposits |
| D014076 | Tooth Diseases |
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