Orthodontic Appliances, Adverse Effects,Gingivitis, Dental Plaque, Periodontal DiseasesNCT07526805
Digital Manufacturing and Periodontal Performance of CAD/CAM-Customized Orthodontic Molar Bands Compared With Standard Stainless-Steel Bands
A study testing Stainless-Steel Orthodontic Molar Bands in people with Orthodontic Appliances, Adverse Effects,Gingivitis, Dental Plaque, Periodontal Diseases, run by Dimitrie Cantemir University at 1 site in Romania.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 17 years
- Conditions the study is for
- Orthodontic Appliances, Adverse Effects,Gingivitis, Dental Plaque, Periodontal Diseases
- What is being tested?
- Stainless-Steel Orthodontic Molar Bands
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteRomania
- Study dates
- 15 May 2024to 26 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Stainless-Steel Orthodontic Molar Bands
- Keywords
- CAD/CAM manufacturing; orthodontic bands; periodontal health; digital dentistry; stainless steel biomaterials; orthodontic appliances
- Medical subject headings
- Gingivitis, Dental Plaque, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stainless-Steel Orthodontic Molar BandsDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Stainless-Steel Orthodontic Molar Bands |
| 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 Receives: Device: Stainless-Steel Orthodontic Molar Bands |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 1 month, 3 months, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start15 May 2024
- Primary completion16 Feb 2026
- Study completion26 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthodontic Appliances, Adverse Effects,Gingivitis, Dental Plaque, Periodontal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dimitrie Cantemir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sorana-Maria Bucur, Dimitrie Cantemir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07526805
- Sponsor's protocol ID
- Orthodontic Molar Bands
- Other IDs
- Approval No. 2709/27.12.2023
- Status last verified
- Apr 2026
- First submitted
- 7 Apr 2026
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Manufacturing and Periodontal Performance of CAD/CAM-Customized Orthodontic Molar Bands Compared With Standard Stainless-Steel Bands
- ClinicalTrials.gov ID
- NCT07526805
- Acronym / sponsor ID
- Orthodontic Molar Bands
- Keywords
- CAD/CAM manufacturing; orthodontic bands; periodontal health; digital dentistry; stainless steel biomaterials; orthodontic appliances
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Dimitrie Cantemir UniversityUniversity, hospital or other
- Study start
- 15 May 2024 (actual)
- Primary completion
- 16 Feb 2026 (actual)
- Study completion
- 26 Feb 2026 (actual)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| CAD/CAM-Customized Molar Bands | Experimental | Device: Stainless-Steel Orthodontic Molar BandsARM 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 |
| Standard Stainless-Steel Molar Bands | Active comparator | Device: Stainless-Steel Orthodontic Molar BandsParticipants 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 |
Who may qualify
- Ages
- 9 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stainless-Steel Orthodontic Molar BandsPatient-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. | Device | CAD/CAM-Customized Molar Bands, Standard Stainless-Steel Molar Bands |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stainless-Steel Orthodontic Molar Bands in people with Orthodontic Appliances, Adverse Effects,Gingivitis, Dental Plaque, Periodontal Diseases, run by Dimitrie Cantemir University at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.