Activation Intervals Effects on Non-surgical Maxillary Expansion in Adults

Maxillary Anomaly Clinical Trial

Official title:

Activation Intervals Effects on Non-surgical Semi-rapid Maxillary Expansion in Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04041804
• Other study ID #: 044
• Status: Recruiting
• Phase: N/A
• Start date: February 2021
• Est. completion date: December 2022

Study information

• Verified date: August 2020
• Source: Fundación Universitaria CIEO
• Contact: Sonia Plaza, MSD
• Phone: 573183973032
• Email: orthoplaza[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2022
• Est. primary completion date: July 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Congenital Abnormalities
• Maxillary Anomaly

Intervention

Procedure:
• semirapid maxillary expansion (SRME)
A Banded Hyrax is going to be used in order to provide an increase in the maxillary transverse dimension

Locations

Country	Name	City	State
Colombia	Fundación Universitaria UniCIEO	Bogotá	DC

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Universitaria CIEO

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transversal distance between upper canines, first premolars and upper first molars	Distance between mesial fosa of each upper canines, first premolars and distance between central fosa of each upper first molars	Change from baseline to 6 months
Primary	Posterior teeth buccal inclination	Measure in CBCT in a coronal slice between the palatal plane and the dental axis	Change from baseline to 6 months
Primary	Buccal bone area evaluation	Measure in CBCT in a coronal slice, thickness of the buccal bone in upper first premolars and upper first molars	Change from baseline to 6 months
Secondary	Bleeding on probing (BP)	It's going to be measured by clinical exam with a periodontal probe and it is verified the presence of bleeding and it will be register as 0= No bleeding and 1= bleeding	Change from baseline to 6 months
Secondary	Evaluation of the perception of pain by the patient (VAS)	Pain visual analogue scale (AVS) - from 0 to 10 points, Higher values represent more pain perception by the participant	Change from baseline to 6 months
Secondary	Probing depth (PD)	Probing depth (PD): It's going to be measured by clinical exam with a periodontal probe and it is measured from the gingival margin to the bottom of the groove. It is considered the presence of a periodontal pocket when the depth of the groove is greater than 3mm.	Change from baseline to 6 months
Secondary	Clinical attachment level (CAL)	Linear measurement in mm. It is constructed from the relationship between probe depth (PD) and the measurement in millimeters from the cement enamel junction (CEJ) to the gingival margin	Change from baseline to 6 months
Secondary	Soft tissue recession (STR)	Soft tissue apical migration of the cement-enamel junction, it is going to classified as: Class I: Retraction of marginal tissue that does not extend to the mucogingival junction without loss of interdental tissue.; Class II: Retraction of marginal tissue that extends to the mucogingival junction, or beyond it, there is no loss of bone, nor of interdental soft tissue.	Change from baseline to 6 months