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NCT Number: NCT07760935

Digital vs Conventional VFR in Post-Orthodontic Retention

This study is comparing two ways of making a retainer, the clear, removable kind worn after braces to see whether the way it's made affects gum health. One type is made using a digital scan of the teeth, and the other is made the traditional way, using a plaster mold. The study will look at how each type affects plaque buildup, gum swelling, and the depth of the space between the tooth and gum over a six-month period.

About 52 people who have just finished braces on both their upper and lower teeth will take part. Participants will be assigned to one of two groups: one group will receive a digitally made retainer, and the other will receive a traditionally made retainer.

Retainer Fitting Before the study begins, each participant's retainer is custom-made for their teeth, either from a digital scan or a plaster mold, depending on which group they're in. Participants will wear their retainer for 22 hours a day, taking it out only to eat and brush their teeth.

Daily Care Throughout the study, participants will follow the same tooth-brushing and gum-care routine, so that any differences seen between the two groups can be linked to the retainer itself rather than to differences in oral hygiene. Participants will be asked to avoid using mouthwash while wearing the retainer.

Check-Up Visits

Participants will attend four check-ups over six months:

Before the retainer is placed (baseline) One month after placement Three months after placement Six months after placement

At each visit, a dentist will check the teeth and gums for plaque buildup, gum swelling or bleeding, and pocket depth (the space between the tooth and gum) using a small measuring tool called a probe.

Follow-Up The final check-up at six months marks the end of the study for each participant. Participants can leave the study at any time if they choose.

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Key information

Conditions

Periodontal Disease; Gingivitis; Dental Plaque; Malocclusion (Post-orthodontic Treatment) Dental Deposits Dental Plaque Gingival Diseases Gingivitis Infections Malocclusion Mouth Diseases Periodontal Diseases Stomatognathic Diseases Tooth Diseases

Age range

15 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Orthodontic retention is essential to prevent relapse following active orthodontic treatment, and vacuum-formed retainers (VFRs) are widely used due to their aesthetics and ease of fabrication.

Conventional VFRs are fabricated over a plaster model derived from alginate impressions, while digital VFRs are fabricated over a 3D-printed model generated from an intraoral scan.

This randomized clinical trial compares periodontal health outcomes; Plaque Index, Gingival Index, and Periodontal Pocket Depth, between the two fabrication methods.

Fifty-two participants (26 per arm) aged 15-30 years who have completed non-extraction fixed orthodontic treatment on both arches within the last month will be enrolled via non-probability consecutive sampling. Group A will receive digitally fabricated VFRs; Group B will receive conventionally fabricated VFRs, both made of 1.5 mm PETG material. Participants will wear retainers 22 hours daily and follow standardized oral hygiene instructions.

Periodontal parameters will be assessed on index teeth 16, 21, 31, and 46 at baseline (T0) and at 1, 3, and 6 months (T1-T3) post-placement. Gingival Index will follow the Loe and Silness method; Plaque Index will follow the Silness and Loe method; pocket depth will be measured with a UNC-15 probe at six sites per tooth.

Data will be analyzed in SPSS v27 using independent-sample t-tests/Mann-Whitney U tests for between-group comparisons and paired t-tests for within-group change from baseline, with stratification for age and gender as effect modifiers.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients aged 15-30 years
  • Patients with good oral and general health
  • Patients in which both the arches were treated with fixed orthodontic treatment on a non-extraction basis completed within the last 1 month
  • Patients with minimum 24 permanent teeth present EXCLUSION CRITERIA
  • Patients that are medically compromised due to a systemic disease
  • Patients having periodontal disease before debonding
  • Patients with severe and uncontrolled caries
  • Patients having cleft palate or any other severe facial deformity
  • Patients using drugs that have direct or indirect effect on the periodontal health such as phenytoin, cyclosporine etc.
  • Patients that have a habit of chronic smoking
  • Pregnant patients

Treatment and study plan

Digital Vacuum-Formed Retainer

Device

PETG, 1.5 mm, fabricated via intraoral scan and 3D-printed model

Conventional Vacuum-Formed Retainer

Device

PETG, 1.5 mm, fabricated via alginate impression and plaster model

Primary outcomes

  1. Plaque Index

    Time frame: Baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3).

    (Silness and Loe method) 4-point scale (0-3) scored on four surfaces (facial, lingual, mesial, distal) of index teeth 16, 21, 31, 46

  2. Gingival Index

    Time frame: Baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3).

    (Loe and Silness method) 4-point scale (0-3) assessing inflammation and bleeding on four surfaces of index teeth 16, 21, 31, 46

  3. Periodontal Pocket Depth

    Time frame: Baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3)

    measured in mm with a UNC-15 probe at six sites per index tooth (mesiofacial, midfacial, distofacial, mesiolingual, midlingual, distolingual); deepest site recorded

Study contacts

Contact information is provided by the study sponsor or research team.

Dr Syed Riaz Hashim Principal Investigator

CONTACT

[email protected]

+92 3312763463

Sponsors and collaborators

Lead sponsor

Ziauddin University

Other

Registry information

Official study title

Comparison of Periodontal Health Parameters Using Conventional Versus Digital Vacuum Formed Retainer (VFR).

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 12, 2026
Registry last updated
Aug 12, 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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