Digital vs Conventional VFR in Post-Orthodontic Retention

NCT07760935 | Not Yet Recruiting

• 1 other identifier: ZU-ORTHO-VFR-2026-001
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Periodontal Disease; Gingivitis; Dental Plaque; Malocclusion (Post-orthodontic Treatment)

Keywords

Orthodontic retention; vacuum-formed retainer; digital dentistry; intraoral scanning; periodontal health; plaque index; gingival index; periodontal pocket depth

Outcome Measures

Primary Outcomes (3)

• Plaque Index

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

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

• Gingival Index

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

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

• Periodontal Pocket Depth

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

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

Study Arms (2)

Group A - Digital VFR

EXPERIMENTAL

Participants receive a vacuum-formed retainer thermoformed over a 3D-printed model generated from intraoral scanning, worn 22 hours/day for 6 months.

Device: Digital Vacuum-Formed Retainer

Group B - Conventional VFR

ACTIVE COMPARATOR

Participants receive a vacuum-formed retainer thermoformed over a plaster model generated from alginate impressions, worn 22 hours/day for 6 months.

Device: Conventional Vacuum-Formed Retainer

Interventions

Digital Vacuum-Formed Retainer DEVICE

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

Group A - Digital VFR

Conventional Vacuum-Formed Retainer DEVICE

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

Group B - Conventional VFR

Eligibility Criteria

• Age: 15 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ziauddin University: lead

MeSH Terms

Conditions

Periodontal Diseases; Gingivitis; Dental Plaque; Malocclusion

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases; Dental Deposits; Tooth Diseases

Central Study Contacts

Dr Syed Riaz Hashim Principal Investigator

CONTACT

+92 3312763463; syed.hashim@zu.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postgraduate Student, FCPS Orthodontics

Study Record Dates

• First Submitted: August 7, 2026
• First Posted: August 12, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 14, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share