Evaluation of Functional Orthodontic Treatment on Sleep Quality

Polygraphic Evaluation of the Effects of Functional Orthodontic Treatment with Twin Block and Herbst Appliances on Sleep Quality: a Randomized Clinical Trial

Functional appliances are used in the treatment of Class II anomalies caused by mandibular rethrognathia. Herbst which is a fixed and rigid functional appliance and TWB which is removable appliance can be successful in the treatment of mandibular retrognathia in a short period of six to eight months during the pubertal growth phase. An increase in the upper airway size occurs as a result of functional orthopedic treatment devices eliminating the problem of mandibular retrognathia and stimulating mandibular growth. The aim of this randomized controlled trial was to evaluate the effects of TWB and Herbst appliances on sleep quality in children with obstructive sleep apnea. The null hypothesis was that there is no difference for the sleep quality between the appliances.

Study Overview

• Status: Completed
• Conditions: Sleep Apnea Syndromes in Children; Functional Orthodontic Treatment; Mandibular Retrognathia; Upper Airway
• Intervention / Treatment: Procedure: Functional orthodontic treatment

Detailed Description

Introduction: This multicenter clinical study aimed to investigate the effects of twin block (TB) and Herbst functional appliances on sleep quality in children with OSAS and mandibular retrognathia. Methods: A total of 46 patients having mandibular retrognathia and identified with OSA were divided randomly into two groups: twin block (TB) and Herbst functional appliances. Changes in sleep parameters at baseline and an avarage of 8-month follow-up detected by polygraphy and Pittsburg Sleep Quality Index (PSQI) were the primary outcome. Treatment of the mandibular retrognathia was the secondary outcome. hapiro Wilk test and Q-Q graphs were used to examine the distribution assumptions of continuous variables according to groups. Mann Whitney U test was used to evaluate two independent group means or distributions of continuous measurements. Paired sample t test or Wilcoxon signed rank test was used to evaluate the differences between the baseline and follow-up times at p < 0.05 significance level.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Maltepe
    • Istanbul, Maltepe, Turkey
      • Gökçenur Gökçe Kara

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• no prior orthodontic treatment, nasal, tonsillar, or adenoid surgery
• absence of any oral, nasal or systemic disease
• the existence of skeletal Class II and dental Class II Division 1 malocclusion (ANB >4°; SNB <80°; incisor overjet >3 mm)
• requiring functional orthodontic treatment
• Individuals are in the MP3cap and S period according to hand-wrist films, and in the CS3 and CS4 period using the CVM method
• patients with OSA (apnea/hypopnea index (AHI)>1/h

Exclusion Criteria:

• body mass index (BMI) ≥ 30 (weight (kg)/height (m2))
• the presence of nasopharyngeal pathologies, craniofacial anomalies, , systemic disorder, or weak oral hygiene
• history of previous orthodontic treatment

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Herbst; The Herbst appliance is fixed and rigid functional appliance. It consists of attachments (casted splints) in the lateral segments of both jaws which are connected by a telescoping mechanism from the upper posterior to the lower anterior region resulting in mandibular bite jumping.	Procedure: Functional orthodontic treatment; The patients were treated with Twin block and Herbst functional appliances. Alginate impressions and a protrusive wax bite were taken for the construction of each appliance. Each device was fitted and then reviewed 4-6 weeks later. First group was treated with Twin block which was manufactured basically according to the original design described by Clark. The overjet was measured from the patients in centric relationship and maximum protrusion position, and construction bite was recorded with 70% of the total advancement capacity of the mandible and 2-4 mm above the freeway space vertically. Overjet measurements were made at each session and active treatment was terminated when a normal overjet in the retracted position was recorded. Second group was treated with the stainless-steel crown Herbst appliance, included crowned maxillary first molars and mandibular first premolars. The construction bite was recorded with the mandible forward by edge-to-edge incisor position.
Experimental: Twin Block; Twin-block appliance is used with two separate acrylic plates for the lower and upper jaw. It consists of acrylic bite blocks that lock together at a 70° angle, allowing the mandible to be positioned in front.	Procedure: Functional orthodontic treatment; The patients were treated with Twin block and Herbst functional appliances. Alginate impressions and a protrusive wax bite were taken for the construction of each appliance. Each device was fitted and then reviewed 4-6 weeks later. First group was treated with Twin block which was manufactured basically according to the original design described by Clark. The overjet was measured from the patients in centric relationship and maximum protrusion position, and construction bite was recorded with 70% of the total advancement capacity of the mandible and 2-4 mm above the freeway space vertically. Overjet measurements were made at each session and active treatment was terminated when a normal overjet in the retracted position was recorded. Second group was treated with the stainless-steel crown Herbst appliance, included crowned maxillary first molars and mandibular first premolars. The construction bite was recorded with the mandible forward by edge-to-edge incisor position.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correction of mandibular retrognathia	A normal or corrected overjet in the retracted position	Following 6-8 months active treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Polygraphic assessment of sleep parameters	Changes in apnea hypopnea index (AHI)	Following 6-8 months active treatment
Polygraphic assessment of sleep parameters	Changes in number of apnea and hypopnea	Following 6-8 months active treatment
Polygraphic assessment of sleep parameters	Changes in number of hypopnea	Following 6-8 months active treatment
Polygraphic assessment of sleep parameters	Changes in desaturation index	Following 6-8 months active treatment
Polygraphic assessment of sleep parameters	Changes in lowest desaturation	Following 6-8 months active treatment
Polygraphic assessment of sleep parameters	Changes in average saturation	Following 6-8 months active treatment
Polygraphic assessment of sleep parameters	Changes in the value of Supin AHI	Following 6-8 months active treatment

Collaborators and Investigators

• Sponsor: Gökçenur Gökçe Kara
• Collaborators: Ege University; Izmir Katip Celebi University
• Investigators: Principal Investigator: Gökçenur Gökçe Kara, Marmara University

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2021
• Primary Completion (Actual): January 28, 2024
• Study Completion (Actual): May 28, 2024

Study Registration Dates

• First Submitted: October 25, 2024
• First Submitted That Met QC Criteria: October 25, 2024
• First Posted (Actual): October 28, 2024

Study Record Updates

• Last Update Posted (Actual): October 28, 2024
• Last Update Submitted That Met QC Criteria: October 25, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Obstructive sleep apnea; Twin Block; Herbst
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Nervous System Diseases; Jaw Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Jaw Abnormalities; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Mandibular Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Retrognathia; Sleep Apnea Syndromes; Micrognathism
• Other Study ID Numbers: M01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

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