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

April 29, 2026 updated by: Sorana-Maria Bucur, Dimitrie Cantemir University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Romania
    • Romania
      • Târgu Mureş, Romania, Romania, 540545
        • Sorana-Maria Bucur

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CAD/CAM-Customized Molar Bands

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
Device: Stainless-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.
Active Comparator: Standard Stainless-Steel Molar Bands

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
Device: Stainless-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 1 month, 3 months, and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dimitrie Cantemir University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2024

Primary Completion (Actual)

February 16, 2026

Study Completion (Actual)

February 26, 2026

Study Registration Dates

First Submitted

April 7, 2026

First Submitted That Met QC Criteria

April 7, 2026

First Posted (Actual)

April 13, 2026

Study Record Updates

Last Update Posted (Actual)

April 30, 2026

Last Update Submitted That Met QC Criteria

April 29, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Orthodontic Molar Bands
  • Approval No. 2709/27.12.2023 (Registry Identifier: Dimitrie Cantemir Registry)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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