Cleft lip and palate Oral Health
Conditions
Interventions
Informed consent will be obtained from all participants prior to enrollment. Eligible patients with unilateral cleft lip and palate will be clinically and radiographically assessed to ensure they meet
Sponsors
Damascus University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with complete unilateral alveolar clefts of type (A), class III according to the LAHS classification, requiring secondary alveolar bone grafting. This type represents an alveolar cleft extending to the nasal floor. 2. Age between 8 and 11 years. 3. Classified as ASA physical status I or II. 4. Good oral hygiene, defined as a plaque index not exceeding 40% based on O’Leary's index. 5. Written informed consent obtained from the patient's legal guardian after full explanation of the study purpose and procedures.
Exclusion criteria
Exclusion criteria: 1. Presence of bilateral clefts, or cleft lip without involvement of the palate. 2. Presence of additional craniofacial abnormalities or congenital syndromes. 3. Patients with systemic conditions that contraindicate general anesthesia or may impair wound and bone healing (ASA class III or IV). 4. History of previous infection at the alveolar cleft site. 5. Patients who have undergone prior secondary alveolar bone grafting. 6. Refusal of participation by the child or legal guardian.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The volume of newly formed bone within the alveolar cleft, assessed using multislice computed tomography (MSCT). Preoperative cleft volume will be calculated from the initial MSCT scans. Six months postoperatively, the residual defect volume will be measured using the same imaging modality. The volume of newly formed bone will be determined by subtracting the postoperative residual cleft volume from the preoperative cleft volume. This volumetric analysis will be performed using specialized radiographic software to ensure precise measurement and consistency. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Radiographic Bone Density Assessment Radiographic bone density of the newly formed bone will be measured six months postoperatively using multislice computed tomography (MSCT). Measurements will be limited to the internal portion of the grafted defect, excluding adjacent cortical bone. Hounsfield Units (HU) will be used as the measurement scale. Five consecutive 1-mm-thick axial slices will be analyzed, and the mean of these five slices will represent the final bone density value. 2. Fistula Presence Evaluation The presence or absence of postoperative oronasal fistula will be assessed clinically and through patient inquiry at 10 days, 1 month, and 6 months after surgery. 3. Bone Graft Healing Complications Complications related to bone graft healing will be evaluated using the Sanz-Martin criteria one month postoperatively. Parameters include wound dehiscence and presence or absence of infection. 4. Soft Tissue Healing Early soft tissue healing will be assessed weekly during the first postoperative month using the Early Healing Index (EHI). 5. Postoperative Edema Postoperative facial edema will be evaluated using the Chaudhary edema scoring system on days 3, 5, and 7 following surgery. 6.Hospital Stay Duration The number of days each patient remains hospitalized postoperatively will be recorded for both groups. 7. Patient Satisfaction with the Surgical Procedure One month postoperatively, patient satisfaction regarding the surgical procedure itself will be assessed using a visual analog scale (VAS) ranging from 0 to 100. 8. Patient Satisfaction with the Outcome Six months postoperatively, patient satisfaction with the treatment outcome will be evaluated using a visual analog scale (VAS) ranging from 0 to 100. 9. Periodontal Assessment of Adjacent Teeth 9.1. Probing Depth: Measured at six sites around each tooth adjacent to the alveolar cleft using a UNC-15 periodontal probe, preoperatively and at 3 months postoperatively. 9.2. Bleeding on Probing: Recorded as pos | — |
Countries
Syria
Contacts
Public ContactKaled Zain
Outcome results
None listed