closure of defect between teeth in cleft patient by custom made distractor appliance.

EVALUATION OF CLOSURE OF LARGE ALVEOLAR DEFECTS BY VECTOR CONTROLLED TRANSPORT DISTRACTOR IN CLEFT LIP AND PALATE PATIENTS

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/09/015599

Enrollment

Registered

2018-09-05

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: Q371- Cleft hard palate with unilateralcleft lip Health Condition 2: Q35-Q37- Cleft lip and cleft palate Health Condition 3: Q379- Unspecified cleft palate with unilateral cleft lip

Interventions

Intervention1: Custom made Tooth borne Distractor: custom made tooth borne distractor appliance for closure of large alveolar defect Control Intervention1: Not applicable: Not applicable

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subjects with large alveolar cleft of size greater than width of canine after alignment and expansion. 2. Subjects with failure of attempted secondary alveolar bone grafting irrespective of size of defect.

Exclusion criteria

Exclusion criteria: Small alveolar defect less than the width of canine i.e. 9 mm

Design outcomes

Primary

Measure	Time frame
a) PHASE 1- a. Case preparation for maxillary alveolar transport distraction. b) PHASE 2- a. Surgical procedure and closure of alveolar cleft defect by transport distraction c) PHASE 3- a. Assessment of closure of cleft defect post distraction b. Evaluation of pre and post distraction records for quantifying the closure of defect, movement of transport discs and anchorage unit. Timepoint: Assessment using radiovisuogram, lateral cephalogram and orthopantomogram in March 2019 followed by further evaluation in September 2019	—

Measure

Time frame

a) PHASE 1- a. Case preparation for maxillary alveolar transport distraction. b) PHASE 2- a. Surgical procedure and closure of alveolar cleft defect by transport distraction c) PHASE 3- a. Assessment of closure of cleft defect post distraction b. Evaluation of pre and post distraction records for quantifying the closure of defect, movement of transport discs and anchorage unit. Timepoint: Assessment using radiovisuogram, lateral cephalogram and orthopantomogram in March 2019 followed by further evaluation in September 2019

—

Secondary

Measure	Time frame
Assessment for closure of residual defect by Bone graftingTimepoint: Assessment using radiovisuogram in October 2019.	—

Countries

India

Contacts

Public ContactTulika Tripathi

Maulana Azad Institute of Dental Sciences

drtulikatripathi@yahoo.com9654700970

Outcome results

None listed

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