An interventional study of Digital Vacuum-Formed Retainer and Conventional Vacuum-Formed Retainer in Periodontal Disease; Gingivitis; Dental Plaque; Malocclusion (Post-orthodontic Treatment), sponsored by Ziauddin University. Not yet recruiting. Open to participants aged 15 Years to 30 Years. Per ClinicalTrials.gov, last updated 2026-08-14.
Sponsored by Ziauddin University · Not applicable, Interventional, and Other
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.
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.
631 studies on the registry are indexed under Gingivitis; 107 are open to participants now.
This study's planned enrollment of 52 is below the median of 66 across 507 interventional studies indexed under Gingivitis.
Browse Gingivitis studies →Ziauddin University is the lead sponsor of 51 studies on the registry; 9 are open to participants now.
Compared within Gingivitis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Periodontal Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
EXCLUSION CRITERIA
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
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
PETG, 1.5 mm, fabricated via intraoral scan and 3D-printed model
PETG, 1.5 mm, fabricated via alginate impression and plaster model
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
Time frame: 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
Time frame: 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
Time frame: Baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3)
No study locations are listed for this record.
Plan to share: No
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This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Ziauddin University