Prospective study for the evaluation of improvement in breathing during sleep and improvement in quality of life after jaw lenthening procedure of mandible in patients with backwardly placed mandible due to jaw joint ankylosis

Prospective study for the evaluation of change in apnoea hypopnoea index (AHI) and improvement in quality of life after distraction osteogenesis of mandible in obstructive sleep apnoea (OSA) patients seconadary to retrognathia in temporomandibular joint (TMJ) ankylosis

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/01/023071

Enrollment

Registered

2020-01-31

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: M958- Other specified acquired deformities of musculoskeletal system

Interventions

Intervention1: Distraction osteogenesis of Mandible: 1) Case selection:- based on inclusion criteria 2) Pre-surgical evaluation:- Detailed history and examination will be done . 1.Polysomnography (AHI

and airway volume will be measured using LDCT. Pre and post operative data will be compared. Data would be analyzed by suitable statical analysis. Control Intervention1: NIL: NIL

Eligibility

Inclusion criteria

Inclusion criteria: Patients with mandibular retrognathia secondary to TMJ ankylosis with polysomnographic evidence of OSA (AHI >10).

Exclusion criteria

Exclusion criteria: 1. Patient not giving consent. 2. Pregnant patient. 3. Patients with other systemic and metabolic disease.

Design outcomes

Primary

Measure	Time frame
To evaluate preoperative and postoperative apnea- hypopnea index (AHI) by polysomnography in patients with OSA.Timepoint: Patient will be followed for atleast for 6 months post distraction	—

Secondary

Measure	Time frame
To evaluate change in snoring and daytime sleepiness in patients with OSA.Timepoint: 6 months post distraction;To evaluate preoperative and postoperative posterior airway space and position of the mandible by cephalometric analysis.Timepoint: 6 months post distraction;To evaluate the increase in airway volume after distraction osteogenesisTimepoint: 6 months post distraction;To evaluate the quality of life of OSA patients pre and post distraction osteogenesis using OSA-18 questionaire.Timepoint: 6 months post distraction;To quantify 3D volume of airway pre-distraction osteogenesis and post-distraction osteogenesis.Timepoint: 6 months post distraction	—

Measure

Time frame

To evaluate change in snoring and daytime sleepiness in patients with OSA.Timepoint: 6 months post distraction;To evaluate preoperative and postoperative posterior airway space and position of the mandible by cephalometric analysis.Timepoint: 6 months post distraction;To evaluate the increase in airway volume after distraction osteogenesisTimepoint: 6 months post distraction;To evaluate the quality of life of OSA patients pre and post distraction osteogenesis using OSA-18 questionaire.Timepoint: 6 months post distraction;To quantify 3D volume of airway pre-distraction osteogenesis and post-distraction osteogenesis.Timepoint: 6 months post distraction

—

Countries

India

Contacts

Public ContactDr Ongkila Bhutia

All India Institute of Medical Sciences New Delhi

dr_ongkila@rediffmail.com9313349564

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026