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Activation Intervals Effects on Non-surgical Maxillary Expansion in Adults

F

Fundación Universitaria CIEO

Status

Unknown

Conditions

Maxillary Anomaly

Treatments

Procedure: semirapid maxillary expansion (SRME)

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

OBJECTIVE: To evaluate the effects of different time intervals activations on the non-surgical maxillary expansion in adults. Methods: This study will include two groups, 10 adult patients each (mean age 20-35) with maxillary transverse deficiency and unilateral or bilateral crossbite. In the first group, the expansion is going to be activated every four days. In the second group, activation will occur every eight days. The primary outcomes are transverse dimension, the buccal cortical bone formation, and the upper premolar and molar labial inclination. Dentoalveolar changes will be evaluated using CBCT images and digital models.

Enrollment

20 estimated patients

Sex

All

Ages

20 to 35 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

  • Presence of transverse maxillary deficiency unilateral or bilateral in which the maxillary cusps of at least two premolars and/or maxillary molars occluded on the central fossa of the antagonist's teeth
  • The needs of maxillary expansion for the correction of their malocclusion
  • Age range from 20 to 35
  • Non-gingivitis or untreated caries at the start of orthodontic treatment
  • Probing depth less than 4mm across the entire dentition
  • Gingival index ≤ 1
  • Plaque index ≤ 1

Exclusion Criteria:

  • Increased Monson curve
  • Patients with systemic disease
  • Patients with congenital anomalies
  • Medicated patients (long term use of antibiotics, Phenytoin, cyclosporine, anti-inflammatory drugs, systemic corticosteroids, and calcium channel blockers)
  • Pregnancy
  • Poor oral hygiene for more than two visits
  • Radiographic evidence of moderate to severe bone loss
  • Current periodontal disease
  • Patients who smoke
  • Individuals with inadequately treated endodontic problems in the study area.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

20 participants in 2 patient groups

Every week RPE activation
Active Comparator group
Description:
Non-surgical semi-rapid maxillary expansion (SRME) with the time intervals activation every week until getting the require expansion needed
Treatment:
Procedure: semirapid maxillary expansion (SRME)
Every four days RPE activation
Active Comparator group
Description:
Non-surgical semi-rapid maxillary expansion (SRME) with the time intervals activation every four days until getting the require expansion needed
Treatment:
Procedure: semirapid maxillary expansion (SRME)

Trial contacts and locations

1

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Central trial contact

Sonia Plaza, MSD

Data sourced from clinicaltrials.gov

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