NCT07150572

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

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2025

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

August 25, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 2, 2025

Completed
Last Updated

September 2, 2025

Status Verified

August 1, 2025

Enrollment Period

2 years

First QC Date

August 25, 2025

Last Update Submit

August 25, 2025

Conditions

Keywords

maxillary transverse deficiencysurgery asssisted rapid maxillary expansiontooth color

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

EXPERIMENTAL

Under general anesthesia, the patients underwent a maxillary expansion procedure, during which the maxillary resistance sites were surgically released

Procedure: surgery assisted rapid maxillary expansion

control group

NO INTERVENTION

no intervention

Interventions

Under general anesthesia, the patients underwent a maxillary expansion procedure, during which the maxillary resistance sites were surgically released

Study Group

Eligibility Criteria

Age16 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

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)

Location

Study Officials

  • Ezgi Sunal Akturk, Assistant Professor

    Saglik Bilimleri Universitesi

    STUDY CHAIR
  • Gokmen Kurt, Professor

    Bezmialem Vakif University

    STUDY CHAIR
  • Fatma Derin Alpaydin, Research Assistant

    Bezmialem Vakif University

    PRINCIPAL INVESTIGATOR

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

Locations