Periodontal Disease; Gingivitis; Dental Plaque; Malocclusion (Post-orthodontic Treatment)NCT07760935
Digital vs Conventional VFR in Post-Orthodontic Retention
A study testing Digital Vacuum-Formed Retainer and Conventional Vacuum-Formed Retainer in people with Periodontal Disease; Gingivitis; Dental Plaque; Malocclusion (Post-orthodontic Treatment), run by Ziauddin University.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 30 years
- Conditions the study is for
- Periodontal Disease; Gingivitis; Dental Plaque; Malocclusion (Post-orthodontic Treatment)
- What is being tested?
- Digital Vacuum-Formed Retainer and Conventional Vacuum-Formed Retainer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read more
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.
Read the detailed description
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.
- Being tested
- Digital Vacuum-Formed Retainer, Conventional Vacuum-Formed Retainer
- Keywords
- Orthodontic retention; vacuum-formed retainer; digital dentistry; intraoral scanning; periodontal health; plaque index; gingival index; periodontal pocket depth
- Medical subject headings
- Periodontal Diseases, Gingivitis, Dental Plaque, Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Vacuum-Formed RetainerDevice
PETG, 1.5 mm, fabricated via intraoral scan and 3D-printed model
Conventional Vacuum-Formed RetainerDevice
PETG, 1.5 mm, fabricated via alginate impression and plaster model
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Conventional Vacuum-Formed Retainer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: Baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal Disease; Gingivitis; Dental Plaque; Malocclusion (Post-orthodontic Treatment)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ziauddin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Syed Riaz Hashim, Ziauddin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07760935
- Sponsor's protocol ID
- ZU-ORTHO-VFR-2026-001
- Status last verified
- Aug 2026
- First submitted
- 7 Aug 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Periodontal Health Parameters Using Conventional Versus Digital Vacuum Formed Retainer (VFR).
- ClinicalTrials.gov ID
- NCT07760935
- Acronym / sponsor ID
- ZU-ORTHO-VFR-2026-001
- Keywords
- Orthodontic retention; vacuum-formed retainer; digital dentistry; intraoral scanning; periodontal health; plaque index; gingival index; periodontal pocket depth
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Ziauddin UniversityUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 12 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A - Digital VFR | Experimental | Device: Digital Vacuum-Formed RetainerParticipants receive a vacuum-formed retainer thermoformed over a 3D-printed model generated from intraoral scanning, worn 22 hours/day for 6 months. |
| Group B - Conventional VFR | Active comparator | Device: Conventional Vacuum-Formed RetainerParticipants receive a vacuum-formed retainer thermoformed over a plaster model generated from alginate impressions, worn 22 hours/day for 6 months. |
Who may qualify
- Ages
- 15 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital Vacuum-Formed RetainerPETG, 1.5 mm, fabricated via intraoral scan and 3D-printed model | Device | Group A - Digital VFR |
| Conventional Vacuum-Formed RetainerPETG, 1.5 mm, fabricated via alginate impression and plaster model | Device | Group B - Conventional VFR |
Primary outcome
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Vacuum-Formed Retainer and Conventional Vacuum-Formed Retainer in people with Periodontal Disease; Gingivitis; Dental Plaque; Malocclusion (Post-orthodontic Treatment), run by Ziauddin University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr Syed Riaz Hashim Principal Investigator (+92 3312763463, syed.hashim@zu.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plaque Index (time frame: Baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.