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The goal of this clinical trial is to learn if hyaluronic acid and corticosteroid improves wound healing in diabetic patients after oral extraction.
After sample size estimation via Open Epi of 128, randomized clinical trial was performed on the patients from Oral and Maxillofacial Surgery Department in Madinah Teaching Hospital, Faisalabad. Patients were divided into three groups. Group 1 was subjected as control group, Group 2 was treated post extraction with 0.2 % Hyaluronic acid (Gengigel Gingival Gel 20ml, Ricerfarma, Milan, Italy) and Group 3 was treated with single dose Hy-Cortisone Injection 250 mg (Generic name: Hydrocortisone Sodium Succinate, Cirin Pharmaceuticals Pakistan) intramuscularly after extraction. Wound healing was assessed through Landry Healing Index. One-way ANOVA test was applied for comparative analysis and Post Hoc Tuckey's test was applied for pairwise comparisons between the groups
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group 1 | No Intervention | The sockets untreated with hyaluronic acid and corticosteroid injection were designated as control group 1 where wound healing took place naturally via clot formation. | |
| Group 2 | Active Comparator | Patients treated with 0.2 % Hyaluronic acid (Gengigel Gingival Gel 20ml, Ricerfarma, Milan, Italy) applied in extraction socket. |
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| Group 3 | Active Comparator | The extraction socket of these patients were treated with a single dose of Hy-Cortisone Injection 250 mg (Generic name: Hydrocortisone Sodium Succinate, Cirin Pharmaceuticals, Pakistan). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyaluronic Acid (HA) | Drug | Gengigel Gingival Gel 20ml, Ricerfarma, Milan, Italy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Wound healing | The wound healing after follow was assessed via Landry Healing Index. This index had five grades very poor (1), poor (2), good (3), very good (4) and excellent (5). Each grade further had five parameters that included tissue color, response to palpation, granulation tissue, incision margin and suppuration. Tissue color was further categorized into >50% of red gingiva for grade 1 and 2. For grade 3 tissue color was specified as 25-50% of red gingiva. Less than 25% for grade 4 and all pink tissues for grade 5.Response to palpation was assessed as yes for grade 1 and 2, and no for the remaining three grades. The presence of granulation tissue was examined as yes for grade 1 and 2, and no for grade 3, 4 and 5. If the Incision margin was not epithelialized with loss of epithelium beyond incision margin it was considered grade 1. Incision margin not epithelialized with connective tissue exposure was marked as grade 2. For grade 3, 4 and 5, the connective tissue exposure was nil. | 6 days |
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Inclusion Criteria:
• Controlled diabetic patients who had random blood glucose levels of 80 to 130 mg/dl, according to World Health Organization.
Exclusion Criteria:
• Patients who declined to participate.
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| Name | Affiliation | Role |
|---|---|---|
| Rimsha Rasheed, BDS, MPhil Physiology | The University of Faisalabad | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Oral and Maxillofacial Surgery, Madinah Teaching Hospital, Faisalabad | Faisalabad | Punjab Province | 38000 | Pakistan |
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| Label | URL |
|---|---|
| Implicates the role of hyaluronic acid in every major wound healing event. | View source |
| Describes the beneficial role of corticosteroid to reduce post operative pain and inflammation. | View source |
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Patient data is kept confidential.
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| Corticosteroid Injection | Drug | Hydrocortisone Sodium Succinate, Cirin Pharmaceuticals, Pakistan |
|
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D006820 | Hyaluronic Acid |
| D000305 | Adrenal Cortex Hormones |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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