Activation Intervals Effects on Non-surgical Maxillary Expansion in Adults

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

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.

Study Overview

• Status: Unknown
• Conditions: Maxillary Anomaly
• Intervention / Treatment: Procedure: semirapid maxillary expansion (SRME)

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sonia Plaza, MSD; Phone Number: 573183973032; Email: orthoplaza@hotmail.com

Study Locations

• Colombia
  • DC
    • Bogotá, DC, Colombia, 110111
      • Recruiting
      • Fundación Universitaria UniCIEO
      • Contact: Sonia P Plaza, Msc; Phone Number: 573183973032; Email: sp.plaza@unicieo.edu.co
      • Contact: Elsa Arango, DDs; Phone Number: 573102857936; Email: evarango8@gmail.com
      • Sub-Investigator: Claudia Ramirez, DDs

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Every week RPE activation; Non-surgical semi-rapid maxillary expansion (SRME) with the time intervals activation every week until getting the require expansion needed	Procedure: semirapid maxillary expansion (SRME); A Banded Hyrax is going to be used in order to provide an increase in the maxillary transverse dimension; Other Names: Maxillary Expansion
Active Comparator: Every four days RPE activation; Non-surgical semi-rapid maxillary expansion (SRME) with the time intervals activation every four days until getting the require expansion needed	Procedure: semirapid maxillary expansion (SRME); A Banded Hyrax is going to be used in order to provide an increase in the maxillary transverse dimension; Other Names: Maxillary Expansion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Fundación Universitaria CIEO
• Investigators: Study Chair: Elsa Arango, DDS, Fundación Universitaria UniCIEO

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2021
• Primary Completion (Anticipated): July 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: February 13, 2019
• First Submitted That Met QC Criteria: July 31, 2019
• First Posted (Actual): August 1, 2019

Study Record Updates

• Last Update Posted (Actual): September 2, 2020
• Last Update Submitted That Met QC Criteria: August 31, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Palatal Expansion Technique; Cone-Beam Computed Tomography
• Other Study ID Numbers: 044

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No