Effect of Hyaluronic Acid and Single Dose Corticosteroid Injection to Improve Wound Healing in Controlled Diabetic Patients Post Tooth Extraction.

Rimsha Rasheed128 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

128

Conditions

Diabetes Mellitus Wound Healing Delayed

Interventions

Hyaluronic Acid (HA)DRUG

Gengigel Gingival Gel 20ml, Ricerfarma, Milan, Italy

Corticosteroid InjectionDRUG

Hydrocortisone Sodium Succinate, Cirin Pharmaceuticals, Pakistan

Eligibility

Sex: ALLMin age: 25 YearsMax age: 55 Years

Medical Language ↔ Plain English

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.

Locations (1)

Department of Oral and Maxillofacial Surgery, Madinah Teaching Hospital, Faisalabad

Faisalabad, Punjab Province, Pakistan

Outcomes

Primary Outcomes

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.

Time frame: 6 days

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.