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New treatment option for Malocclusion
Official title A Prospective Multicenter Clinical Investigation Evaluating the Accuracy of the Trimline Design When Treated With SureSmile® Aligners.
ClinicalTrials.gov ID: NCT07290790
What this study is testing
- What it's testing
- This is a three-armed, multicenter clinical study evaluating the SureSmile clear aligner medical device. The primary objective is to confirm the safety and assess the accuracy of different tooth movements.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Subject willing to participate in the clinical investigation, able to understand the intent risks and benefits of the clinical investigation as well...
- Subject has signed and dated the informed consent form (ICF) .
- Subject aged 18 years or above at time of informed consent.
- Subject has permanent dentition (i.e., all 2nd molars).
- Subject with a dental malocclusion, consistent with Levels 1 and 2 case complexity and within the clinical references as defined in the SureSmile...
You likely can't join if
- . Exclusion Criteria:
- people unlikely to comply with investigational procedures, or unlikely to come back for follow-up visits, as judged by the Investigator.
- Subject that presents a dental malocclusion classified as level 3 case complexity, as defined in the SureSmile Case Selection Guide.
- people who have completed aligner therapy within the last 12 months or who are in active orthodontic treatment.
- people with active periodontal disease or other unresolved dental conditions such as active cavities, active periodontal disease.
- people with treatment plans requiring transverse correction requiring expansion greater than 4 mm per arch or 2 mm per quadrant, or any skeletal...
See the full eligibility criteria
- Subject willing to participate in the clinical investigation, able to understand the intent risks and benefits of the clinical investigation as well as associated time commitment and follow-ups visits.
- Subject has signed and dated the informed consent form (ICF) .
- Subject aged 18 years or above at time of informed consent.
- Subject has permanent dentition (i.e., all 2nd molars).
- Subject with a dental malocclusion, consistent with Levels 1 and 2 case complexity and within the clinical references as defined in the SureSmile Case Selection Guide.
- Crowding or spacing must be ≤6mm present in one or both arches consistent with level 1 and 2 of case complexity.
- Midline deviation must be ≤3 mm consistent with level 1 and 2 of case complexity.
- Overjet must be ≤4 mm consistent with level 1 and 2 case complexity.
- Overbite must be ≤3 mm consistent with level 1 and 2 case complexity.
- Anterior open bite must be ≤1 mm, consistent with level 1 and 2 case complexity.
- Intermaxillary elastics may be included within the treatment plan to support sagittal, vertical, or transverse correction within the limits defined under
- . Exclusion Criteria:
- people unlikely to comply with investigational procedures, or unlikely to come back for follow-up visits, as judged by the Investigator.
- Subject that presents a dental malocclusion classified as level 3 case complexity, as defined in the SureSmile Case Selection Guide.
- people who have completed aligner therapy within the last 12 months or who are in active orthodontic treatment.
- people with active periodontal disease or other unresolved dental conditions such as active cavities, active periodontal disease.
- people with treatment plans requiring transverse correction requiring expansion greater than 4 mm per arch or 2 mm per quadrant, or any skeletal transverse correction.
- Treatment plans requiring sagittal correction exceeding a half-cusp discrepancy (i.e., \>½ unit) in molar or canine relationships.
- people with treatment plans require vertical correction beyond Level 1 and 2 thresholds (i.e., overbite \>3 mm or anterior/posterior open bite \>1 mm), or vertical elastics exceeding 3 mm.
- TMJ (Temporo-Mandibular Join) disorders or history of headaches or migraines.
- Participants with known history of plastic allergies.
- people with presence of skeletal discrepancies necessitating orthognathic surgery, rapid palatal expansion, other orthopedic intervention, unilateral or bilateral cross-bites, mandibular deviations in association with...
- The use of TADs (Temporary Anchor Devices), plates, other fixed anchorage ancillaries or the use of functional appliances (distalizers, growth modification devices), any approach involving orthopedic or skeletal...
- Uncontrolled para-functional habits, e.g., bruxism.
- Any other condition that would make the subject unsuitable for participation, including but not limited to:
- Unstable psychiatric illness.
- Recent myocardial infarction (\< 3 months\ ).
- Recent cerebrovascular accident (\< 3 months\ ).
- Recent cardiac-valvular prosthesis placement (\< 3 months\ ).
- Hemorrhagic diathesis.
- Severe liver dysfunction.
- Known or suspected current malignancy.
- Known pregnancy at the time of enrolment.
- Previous enrolment in the present clinical investigation.
- Involvement in the planning and conduct of the clinical investigation (applies to both Dentsply Sirona personnel and the clinical investigation site).
- Participation in another clinical investigation that may interfere with the present clinical investigation.
The study team makes the final eligibility decision.
Where it's taking place
- Fresno, California, United States
- Princeton Junction, New Jersey, United States
- Huntersville, North Carolina, United States
- Frisco, Texas, United States
- Barcelona, Spain
- Bexleyheath, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fresno, California, United States; Princeton Junction, New Jersey, United States; Huntersville, North Carolina, United States; Frisco, Texas, United States; Barcelona, Spain; Bexleyheath, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.