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Completed

NCT Number: NCT07150572

Evaluation of the Effect of Surgically Assisted Rapid Maxillary Expansion on Tooth Color

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.

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Key information

Age range

16 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bezmialem Vakif University

Istanbul, Fatih, 34093, Turkey (Türkiye)

About this study

In this study fifteen patients who underwent SARME and fifteen untreated control patients were included. Color measurements of the six maxillary anterior teeth were performed using a spectrophotometer. Periodontal health was assessed using the Gingival Index(GI), Probing Depth(PD), Plaque Index(PI), while pulp sensitivity was evaluated using an electric pulp tester(EPT). Color changes were calculated and fractal analysis was performed on CBCT images obtained evaluate the trabecular bone structure adjacent to the maxillary central incisors.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Inclusion criteria

for the study group:

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.

Inclusion criteria

for the control group:

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.

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Exclusion criteria

  • Exclusion criteria for both groups:

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.

Treatment and study plan

surgery assisted rapid maxillary expansion

Procedure

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

Primary outcomes

  1. Tooth color parameters

    Time frame: 17 months

    In this study patient who underwent SARME and untreated control groups teeth color were measured with spectrophotometer.

Sponsors and collaborators

Lead sponsor

Bezmialem Vakif University

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Sep 2, 2025
Registry last updated
Sep 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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