Digital vs Conventional VFR in Post-Orthodontic Retention
Comparison of Periodontal Health Parameters Using Conventional Versus Digital Vacuum Formed Retainer (VFR).
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.
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Dr Syed Riaz Hashim Principal Investigator
- Telefoonnummer: +92 3312763463
- E-mail: syed.hashim@zu.edu.pk
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
Accepteert gezonde vrijwilligers
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Group A - Digital VFR
Participants receive a vacuum-formed retainer thermoformed over a 3D-printed model generated from intraoral scanning, worn 22 hours/day for 6 months.
|
PETG, 1.5 mm, fabricated via intraoral scan and 3D-printed model
|
|
Actieve vergelijker: Group B - Conventional VFR
Participants receive a vacuum-formed retainer thermoformed over a plaster model generated from alginate impressions, worn 22 hours/day for 6 months.
|
PETG, 1.5 mm, fabricated via alginate impression and plaster model
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Plaque Index
Tijdsspanne: 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
|
Baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3).
|
|
Gingival Index
Tijdsspanne: 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
|
Baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3).
|
|
Periodontal Pocket Depth
Tijdsspanne: 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
|
Baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3)
|
Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- ZU-ORTHO-VFR-2026-001
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .