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NCT06949527: OB-MUSCLE
Effects of Open Bite Activator and Skeletal Anchorage-Supported Vertical Elastics on the Masseter Muscle
NA trial testing Open Bite Activator with Skeletal Anchorage-Supported Vertical Elastics in Hyperdivergent Facial Pattern in 24 participants. Completed in 15 January 2025.
15 January 2025
Quick facts
| Lead sponsor | Murat Kaan Erdem |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 24 |
| Start date | 15 January 2024 |
| Primary completion | 15 January 2025 |
| Estimated completion | 15 January 2025 |
| Sites | 1 location across Turkey (Türkiye) |
Drugs / interventions tested
- Open Bite Activator with Skeletal Anchorage-Supported Vertical Elastics
Conditions studied
- Hyperdivergent Facial Pattern — all drugs for Hyperdivergent Facial Pattern →
- Skeletal Open Bite — all drugs for Skeletal Open Bite →
- Hyperdivergent Growth Pattern — all drugs for Hyperdivergent Growth Pattern →
- Anterior Open Bite — all drugs for Anterior Open Bite →
Sponsor
Murat Kaan Erdem
Who can join
Adults 12 to 14, any sex, with Hyperdivergent Facial Pattern or Skeletal Open Bite. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This clinical trial aims to evaluate the effects of a combined treatment involving an open bite activator and anterior skeletal anchorage-supported vertical elastics on the masseter muscle in children with skeletal open bite. A total of 24 growing individuals with increased vertical skeletal pattern were treated with a functional appliance and intermaxillary vertical elastics supported by miniscrews placed in the anterior region. Ultrasonographic and sonoelastographic assessments were performed at baseline, 6 months, and 12 months to measure changes in masseter muscle thickness and stiffness. Cephalometric radiographs were also used to evaluate dentofacial structural changes. This study aims to provide insight into the soft tissue changes associated with functional orthopedic treatment in hyperdivergent patients.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06949527
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Open Bite Activator with Skeletal Anchorage-Supported Vertical Elastics
Trials testing the same drug.
- NCT06936371 — Treatment of Skeletal Open Bite With Open Bite Activator and Skeletal Anchorage-Supported Vertical Elastics · NA · completed
Other Murat Kaan Erdem trials
Trials by the same sponsor.
- NCT07279662 — Comparison of Skeletal Anchorage Versus Conventional Tooth-Borne Face Mask Therapy Following the Alt-RAMEC Protocol · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06949527 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Murat Kaan Erdem
- Last refreshed: 29 April 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06949527.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing