Skip to content

Are braces effective for patients with unilateral cleft palate undergoing alveolar bone graft surgery?

Reducing the burden of Orthodontic Care for children with Clefts: Evaluating the effectiveness of Pre-alveolar Bone Graft Orthodontics in unilateral non-syndromic Cleft patients (PABO Study) - PABO

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/10/028756
Enrollment
70
Registered
2020-10-29
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: Q351- Cleft hard palate

Interventions

Intervention1: Orthodontic treatment: Treatment with orthodontics with pre-alveolar bone graft surgery Intervention2: Orthodontic treatment: Orthodontic treatment with pre-alveolar bone graft for a pe

Sponsors

Badri Thiruvenkatachari
Lead Sponsor
Bharath Institue of Higher Education and Research
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Unilateral cleft alveolus requiring alveolar bone graft. Upper central incisors erupted. Written informed consent. One care/parent must be a native language speaker of the state of residence.

Exclusion criteria

Exclusion criteria: Bilateral Cleft palate Patients with syndromes or other medical condition Subjects involved in any other orthodontic trials Inadequate oral hygiene

Design outcomes

Primary

MeasureTime frame
Success of alveolar bone graft assessed from oblique occlusal (Kindelan method) and CBCTTimepoint: Oblique occlusal: baseline (T1), Pregraft (T3), 3 months post surgery (T4)and six months post surgery (T5) CBCT: six months post surgery (t%)

Secondary

MeasureTime frame
Qualitative assessment using the validated quality of life questionnairesTimepoint: All time points T1-T6;Quality adjusted cost analysis Timepoint: All time points T1-T6;Quality of the dento-occlusal outcome measured on study models using 10 year old index scoresTimepoint: Six months post surgery (T5)

Countries

India

Contacts

Public ContactBadri Thiruvenkatachari

Sree Balaji Dental College and Hospital

badri.t.chari@gmail.com00917358483837

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 14, 2026