Evaluation of the Effect of Surgically Assisted Rapid Maxillary Expansion on Tooth Color
1 other identifier
interventional
30
1 country
1
Brief Summary
This prospective study aimed to evaluate effects of surgically assisted rapid maxillary expansion (SARME) on the color, maxillary anterior teeth by comparing them with untreated control group.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2023
Typical duration for not_applicable
1 active site
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 Start
First participant enrolled
August 10, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 25, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2025
CompletedFirst Submitted
Initial submission to the registry
August 25, 2025
CompletedFirst Posted
Study publicly available on registry
September 2, 2025
CompletedSeptember 2, 2025
August 1, 2025
2 years
August 25, 2025
August 25, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Tooth color parameters
In this study patient who underwent SARME and untreated control groups teeth color were measured with spectrophotometer.
17 months
Study Arms (2)
Study Group
EXPERIMENTALUnder general anesthesia, the patients underwent a maxillary expansion procedure, during which the maxillary resistance sites were surgically released
control group
NO INTERVENTIONno intervention
Interventions
Under general anesthesia, the patients underwent a maxillary expansion procedure, during which the maxillary resistance sites were surgically released
Eligibility Criteria
You may qualify if:
- Young adult patients with completed growth and development,
- Presence of maxillary transverse deficiency greater than 5 mm,
- Patients with bilateral or unilateral posterior crossbite,
- Absence of congenital tooth loss, fractures, restorative procedures, or root canal treatment in the maxillary arch,
- Good patient cooperation.
- Young adult patients with no history of orthodontic treatment,
- Absence of congenital tooth loss, fractures, restorative procedures, or root canal treatment in the maxillary anterior teeth.
You may not qualify if:
- Patients consuming more than two cups of coffee or tea per day,
- Patients who smoke,
- Presence of systemic disorders that interfere with surgical procedures or bone metabolism,
- Patients with craniofacial deformities or syndromic conditions,
- Patients with poor cooperation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bezmialem Vakif University
Istanbul, Fatih, 34093, Turkey (Türkiye)
Study Officials
- STUDY CHAIR
Ezgi Sunal Akturk, Assistant Professor
Saglik Bilimleri Universitesi
- STUDY CHAIR
Gokmen Kurt, Professor
Bezmialem Vakif University
- PRINCIPAL INVESTIGATOR
Fatma Derin Alpaydin, Research Assistant
Bezmialem Vakif University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 25, 2025
First Posted
September 2, 2025
Study Start
August 10, 2023
Primary Completion
July 25, 2025
Study Completion
August 1, 2025
Last Updated
September 2, 2025
Record last verified: 2025-08