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

Effects of Hyaluronic Acid and Corticosteroid in Post Extraction Wound Healing of Diabetic Patients

The goal of this clinical trial is to learn if hyaluronic acid and corticosteroid improves wound healing in diabetic patients after oral extraction.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus; Wound Healing Delayed
• Intervention / Treatment: Drug: Hyaluronic Acid (HA); Drug: Corticosteroid Injection

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

• Study Type: Interventional
• Enrollment (Actual): 128
• Phase: Phase 4

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Faisalabad, Punjab, Pakistan, 38000
      • Department of Oral and Maxillofacial Surgery, Madinah Teaching Hospital, Faisalabad

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group 1; The sockets untreated with hyaluronic acid and corticosteroid injection were designated as control group 1 where wound healing took place naturally via clot formation.
Active Comparator: Group 2; Patients treated with 0.2 % Hyaluronic acid (Gengigel Gingival Gel 20ml, Ricerfarma, Milan, Italy) applied in extraction socket.	Drug: Hyaluronic Acid (HA); Gengigel Gingival Gel 20ml, Ricerfarma, Milan, Italy; Other Names: 0.2% Hyaluronic acid
Active Comparator: Group 3; 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).	Drug: Corticosteroid Injection; Hydrocortisone Sodium Succinate, Cirin Pharmaceuticals, Pakistan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Rimsha Rasheed
• Investigators: Principal Investigator: Rimsha Rasheed, BDS, MPhil Physiology, The University of Faisalabad

Publications and helpful links

Helpful Links

• Implicates the role of hyaluronic acid in every major wound healing event.
• Describes the beneficial role of corticosteroid to reduce post operative pain and inflammation.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Actual): April 30, 2024
• Study Completion (Actual): July 31, 2024

Study Registration Dates

• First Submitted: October 9, 2024
• First Submitted That Met QC Criteria: October 9, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Actual): October 15, 2024
• Last Update Submitted That Met QC Criteria: October 9, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Wound healing post extraction, Single dose corticosteroid, Diabetes Mellitus, Hyaluronic acid
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Wounds and Injuries; Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: Tuf/IRB/293/24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Patient data is kept confidential.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No