Assessment of secondary alveolar bone grafting in cleft lip and palate patients using 3 dimensional cone beam computed tomography

Completed

Conditions: Unilateral cleft lip and palate patients

Registration Number: CTRI/2018/04/013110

Lead Sponsor: Joseph Jose

Brief Summary: Various methods of assessing the success of bone grafts have been proposed for the evaluation of secondary alveolar bone grafting in cleft patients. CBCT is more precise and reliable method compared to two dimensional radiographs to evaluate the size of the alveolar cleft defect, position and level of bone on adjacent teeth and presence of supernumerary teeth. Evaluation based on CBCT gives a better understanding of the defect for the surgeon and orthodontist which helps in treatment plan. Assessment of the bone fill should ideally be carried out at least 3 months after the bone grafting as grafted bone transforms into normal trabecular bone by 3 months. Resorption (height loss) of the bone graft occurs within 3 to 6 months after secondary alveolar bone grafting. The conclusions of the present study are: 1) 2D scales such as Enemarkâ€™s and Chelsea analysis and 3D scale proposed by A J Forte showed 80% of the patients had an acceptable outcome and 20% patients had an unacceptable outcome after secondary alveolar bone grafting. 2) On CBCT evaluation preoperative cleft volume was 0.88 Â± 0.49 cm3 which was reduced to .2Â±.18 cm3 at 3 months and further reduced to .16Â±.18 cm3 at 6 months with percentage of bone fill 76.23% and 82.13 % at 3 months and 6 months respectively. There was an absolute difference of 28.71% of bone fill between 3 months and 6 months. 3) The average density of the unaffected side was 752.26Â± 66.11 HU and coincides with normal radiographic bone density of maxilla, where bone density D3 (350-850HU). Average density of bone graft was 375.38 Â± 148.18 HU at 3 months which was reduced to 347.57 Â± 137.10 HU at 6 months.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 10

Inclusion Criteria

1.Patients with complete unilateral cleft lip and palate 2.Age group between 7 to 12 years.

Exclusion Criteria

1.Patients with bilateral cleft and incomplete clefts 2.There should not be any associated syndromes 3.There should not be any bone pathology.
4.Concurrent use of corticosteroids or immunosuppressive agents.
5.Pathological fractures.
6.Pre-existing vascular disease.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary alveolar bone grafting was done in unilateral cleft lip and palate patients. CBCT scans were taken pre and post bone garfting	T0: before bone grafting

Secondary Outcome Measures

Name	Time	Method
Evalaution based 2D and 3D radiographic scales 80% acceptable outcome and 20% unacceptable outcome was achieved.On CBCT evaluation preoperative cleft volume was reduced at 3 months after bone grafting and further reduced at 6 months after bone grafting. Percentage of bone fill increased from 3 months to 6 months. Average density of bone graft was reduced from 3 months to 6 months after bone grafting.	T1: 3 months after bone grafting

Trial Locations

Locations (1): Institute of dental studies and technologies
🇮🇳
Ghaziabad, UTTAR PRADESH, India
Institute of dental studies and technologies
🇮🇳Ghaziabad, UTTAR PRADESH, India
Joseph Jose
Principal investigator
8979206363
josephjose277@yahoo.com