Polygraphic Evaluation of the Effects of Different Rapid Maxillary Expansion Appliances on Sleep Quality

NCT04529213 | Completed

• 1 other identifier: 0024
• Study Type: interventional
• Target: 46
• Locations: 0 countries
• Sites: N/A

Brief Summary

Rapid maxillary expansion (RME) is a commonly used orthodontic treatment in patients with maxillary constriction to provide skeletal expansion, correct posterior crossbite and resolve naso-respiratory problems by reducing oral respiration.The aim of this randomized controlled trial was to evaluate the effects of tooth-borne, tooth tissue-borne and bone-borne RME appliances on sleep quality with polygraphy. The null hypothesis was that there is no difference for the sleep quality between the appliances.

Conditions

Sleep Apnea Syndromes; Palatal Expansion Technique

Keywords

Polygraphy; Obstructive Sleep Apnea; Rapid Maxillary Expansion

Outcome Measures

Primary Outcomes (1)

• Correction of posterior crossbite

  The palatal cusps of the maxillary posterior teeth approximated the lingual cusps of the mandibular posterior teeth.

  After active expansion (up to 3 weeks). The evaluation of the result has been made by the physician with intraoral clinical examination.

Secondary Outcomes (7)

• Polygraphic assessment of sleep parameters

  After 3 months treatment retention period

• Polygraphic assessment of sleep parameters

  After 3 months treatment retention period

• Polygraphic assessment of sleep parameters

  After 3 months treatment retention period

• Polygraphic assessment of sleep parameters

  After 3 months treatment retention period

• Polygraphic assessment of sleep parameters

  After 3 months treatment retention period

Study Arms (3)

Tooth tissue-borne (KBME) expander

EXPERIMENTAL

In this tooth tissue-borne appliance, the occlusal surfaces of the molar and premolar teeth and half of the palatinal and buccal surfaces are covered with heat polymerized acrylic. Hyrax expansion screw is in the midline, as far as possible to the palate positioned close and parallel

Procedure: Rapid Maxillary Expansion Treatment

Tooth-borne (Hyrax) expander

EXPERIMENTAL

In this tooth-borne expansion appliance, orthodontic bands are placed on the right and left 1st premolar and 1st molar teeth of the patients and the bands are soldered to the Hyrax expansion screw. The expansion screw is in the midline, as far as possible to the palate positioned close and parallel

Procedure: Rapid Maxillary Expansion Treatment

Bone-borne (MIDME) expander

EXPERIMENTAL

This bone-borne expander includes 2 mini-screws with a diameter of 1.6 mm and a length of 10 mm on the right and left sides, coinciding between the roots of the 2nd premolar and 1st molar teeth in addition to the hyrax expansion screw.

Procedure: Rapid Maxillary Expansion Treatment

Interventions

Rapid Maxillary Expansion Treatment PROCEDURE

The patients were treated with KBME, Hyrax and MIDME maxillary expansion appliances, respectively. All expansion appliances containing a Hyrax expansion screw positioned parallel to the second premolars and were used to correct the posterior crossbite. In the MIDME group, two mini-screws with a diameter of 1.6 mm and a length of 10 mm are located on the right and left sides between the roots of the 2nd premolar and 1st molar teeth with 60-70° angle. KBME and Hyrax expansion appliances were cemented with glass ionomer cement and MIDME was cemented with using the light-cured composite. Same protocol was applied to all patients during RME treatment. Expansion screws in all groups were activated by two turns a day.

Bone-borne (MIDME) expander; Tooth tissue-borne (KBME) expander; Tooth-borne (Hyrax) expander

Eligibility Criteria

• Age: 12 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• No previous tonsillar, nasal or adenoid surgery and orthodontic treatment,
• Bilateral crossbite and need for RME,
• Maxillary and mandibular permanent teeth fully erupted,
• Willingness to participate in the study

You may not qualify if:

• the presence of adenotonsillectomy due to tonsillar hypertrophy or adenoidal hypertrophy
• having nasal/nasopharyngeal /oropharyngeal pathologies, craniofacial syndromes, systemic disease, poor oral hygiene,
• history of previous orthodontic treatment.

Sponsors & Collaborators

• Izmir Katip Celebi University: lead

MeSH Terms

Conditions

Sleep Apnea Syndromes; Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Gökçenur Gökçe, Phd

  Izmir Katip Celebi University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: 3-arm parallel trial

Study Record Dates

• First Submitted: August 24, 2020
• First Posted: August 27, 2020
• Study Start: July 1, 2016
• Primary Completion: January 13, 2017
• Study Completion: May 17, 2017
• Last Updated: August 27, 2020

Record last verified: 2020-08