About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Digital Vacuum-Formed Retainer
DevicePETG, 1.5 mm, fabricated via intraoral scan and 3D-printed model
Conventional Vacuum-Formed Retainer
DevicePETG, 1.5 mm, fabricated via alginate impression and plaster model
Treatment groups
Trial outcomes
Primary outcomes
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
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
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
Locations
Sponsors and contacts
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