NCT07726485

Brief Summary

The goal of clinical trial is to know the role clear aligner seater. The main question it aims to answer is to evaluate the use of clear aligner seater on the effectiveness of clear aligner therapy by questioning the predictability of proposed treatment plan.

  • Group A (Regular-use group): Use chewy with the 1st insertion of each aligner sets for a day or a couple of days until the aligner seated well with no gap with the teeth. The patients will be instructed to bite on the chewy while the aligners are in position for few seconds.
  • Group B (customized-use group): In addition to the regular use of the chewy, the participants will be instructed to bite for few seconds while the aligners are in their mouth at bedtime on a daily bases.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
13mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress30%
Feb 2026Sep 2027

Study Start

First participant enrolled

February 16, 2026

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 22, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 24, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

July 24, 2026

Status Verified

July 1, 2026

Enrollment Period

1.5 years

First QC Date

June 22, 2026

Last Update Submit

July 22, 2026

Conditions

Clear Aligner TherapyMalocclusions

Keywords

Clear aligner therapyClear Aligner Seater

Outcome Measures

Primary Outcomes (1)

  • Primary outcome measure

    Tooth movement predictability will be assessed as the absolute difference between the prescribed and achieved tooth movement in linear (mm) and angular (degrees) measurements using three-dimensional digital model superimposition. Digital models will be analyzed using Geomagic Control X software.

    Four months

Secondary Outcomes (2)

  • Pain during clear aligner therapy

    1 hour, 6 hours, 2 days, 5 days, and 7 days after insertion of first aligner.

  • Periodontal health

    Baseline and every monthly follow-up visit throughout the 4-month study period

Study Arms (2)

Regular-use of chewy group

ACTIVE COMPARATOR

Use chewy with the 1st insertion of each aligner sets for a day or a couple of days until the aligner seated well with no gap with the teeth. The patients will be instructed to bite on the chewy while the aligners are in position for few seconds

Device: Aligner seater

Customized-use of chewy group

EXPERIMENTAL

In addition to the regular use of the chewy, the participants will be instructed to bite for few seconds while the aligners are in their mouth at bedtime on a daily bases.

Device: Aligner seater

Interventions

Aligner seaterDEVICE

Participants use silicone aligner seaters during clear aligner therapy. The study compares two different protocols of aligner seater use: regular use and customize use.

Customized-use of chewy groupRegular-use of chewy group

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Male and female participants.
  • Age between 18 and 45 years.
  • Mild to moderate crowding or spacing.
  • ANB angle between 1° and 5°.
  • Planned for non-extraction clear aligner treatment.
  • Willing and able to provide written informed consent and comply with the study protocol.

You may not qualify if:

  • Craniofacial syndromes (e.g., cleft lip and/or palate) or other congenital craniofacial anomalies.
  • Severe crowding.
  • Signs and/or symptoms of temporomandibular disorders (TMD).
  • Previous orthodontic treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Baghdad/ collage of Dentistry

Baghdad, 10047, Iraq

Location

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Officials

  • Farah Alaa Hussein, B.D.S.

    University of Baghdad/ collage of Dentistry

    PRINCIPAL INVESTIGATOR

  • Hadeel Adel Al-lami, Ph.D orthodontics

    University of Baghdad/ collage of Dentistry

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
master student of orthodontics

Study Record Dates

First Submitted

June 22, 2026

First Posted

July 24, 2026

Study Start

February 16, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

July 24, 2026

Record last verified: 2026-07

Locations

IR(1)