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| Name | Class |
|---|---|
| Alexandria University | OTHER |
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To evaluate the health status of the periodontium and dentition at the distraction osteogenesis site in CLP subjects using mid maxillary distraction (MMD).
Segmental forward maxillary distraction osteogenesis(DO)was performed. Distractor connecting buccal molar segments to the anterior maxilla was kept for 7 days. Then distraction was performed till overcorrection and consolidated for 3-months. Periodontal clinical parameters were recorded at baseline, 3 and 6-months postoperatively. Gingival crevicular fluid was collected . Soft tissue healing was evaluated clinically and histologically after distraction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study | Experimental | A Involvement with the osteotomy site of the surgery, osteotomy was performed then GCF were collected from teeth neighboring the |
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| Control | Active Comparator | Involvement with the osteotomy site of the surgery, surgical osteotomy was performed then GCF were collected from teeth away from the osteotomy site |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A Involvement with the osteotomy site of the surgery | Procedure | A Involvement with the osteotomy site of the surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of periodontal inflammatory mediators | periodontal inflammatory mediators IL-1β | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of periodontal inflammatory mediators TNF- α | periodontal inflammatory mediators TNF- α | 7 days |
| Assessment of periodontal probing depth | probing depth measurement |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluating the gingival histological changes | histological examination of the soft tissue | 2 and 4 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marwa Madi | Alexandria University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry | Alexandria | 21221 | Egypt |
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| ID | Term |
|---|---|
| D002971 | Cleft Lip |
| D010514 | Periodontal Pocket |
| D017622 | Periodontal Attachment Loss |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D008047 | Lip Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D009056 | Mouth Abnormalities |
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Surgical distraction was performed in 20 cleft lip and palate (CLP) subjects with class III malocclusion, gingival GCF were collected from teeth neighboring the osteotomy site and from premolars of the opposite arch as control.
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The clinical assessment was not masked , however, the histological and biomarker examination were send to blind investigator not directly involved in the study
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| 3 and 6 month |
| Assessment of clinical attachment loss | clinical attachment loss measurement | 3 and 6 month |
| Assessment of periodontal clinical parameters | Gingival index evaluation GI | 3 and 6 month |
| D018640 |
| Stomatognathic System Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D010518 | Periodontitis |
| D010510 | Periodontal Diseases |
| D055093 | Periodontal Atrophy |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |