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| Name | Class |
|---|---|
| Izmir Katip Celebi University | OTHER |
| Ege University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Herbst | Experimental | 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. |
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| Twin Block | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Functional orthodontic treatment | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Correction of mandibular retrognathia | A normal or corrected overjet in the retracted position | Following 6-8 months active treatment |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gökçenur Gökçe Kara | Marmara University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gökçenur Gökçe Kara | Istanbul | Maltepe | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D008844 | Micrognathism |
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D007569 | Jaw Abnormalities |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D019767 | Maxillofacial Abnormalities |
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2-arm parallel trial
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Double (Participant, Outcomes Assessor)
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| 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 |
| D019465 |
| Craniofacial Abnormalities |
| D009139 | Musculoskeletal Abnormalities |
| D009057 | Stomatognathic Diseases |
| D018640 | Stomatognathic System Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |