Diabetes Mellitus, Wound Healing Delayed
Conditions
Keywords
Wound healing post extraction, Single dose corticosteroid, Diabetes Mellitus, Hyaluronic acid
Brief summary
The goal of this clinical trial is to learn if hyaluronic acid and corticosteroid improves wound healing in diabetic patients after oral extraction.
Detailed description
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
Interventions
DRUGHyaluronic Acid (HA)
Gengigel Gingival Gel 20ml, Ricerfarma, Milan, Italy
DRUGCorticosteroid Injection
Hydrocortisone Sodium Succinate, Cirin Pharmaceuticals, Pakistan
Sponsors
Rimsha Rasheed
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* • Controlled diabetic patients who had random blood glucose levels of 80 to 130 mg/dl, according to World Health Organization. * Age was defined from 25-55, irrespective of the gender. * Tooth extractions in maxilla or mandible without the presence of an acute infection or compromised periodontal state.
Exclusion criteria
* • Patients who declined to participate. * Patients below the age of 25 and above the age of 55. * Patients with uncontrolled diabetes mellitus (blood sugar levels high than the defined range) * Patients with history of adverse effects to local anesthetics or who are currently taking corticosteroids. * Patients with unmaintained oral hygiene and smoking habits. * Confirmation of any chronic illness, including those with hypertension or cardiac disorders. * Patients who have undergone any recent major surgical procedure.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound healing | 6 days | 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. |
Countries
Pakistan
Outcome results
None listed