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

Rimsha Rasheed

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus; Wound Healing Delayed

Treatments: Drug: Hyaluronic Acid (HA); Drug: Corticosteroid Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT06637384

Tuf/IRB/293/24

Details and patient eligibility

About

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

Full 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

Enrollment: 128 patients

Sex: All

Ages: 25 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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128 participants in 3 patient groups

Control Group 1

No Intervention group

Description:

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 group

Description:

Patients treated with 0.2 % Hyaluronic acid (Gengigel Gingival Gel 20ml, Ricerfarma, Milan, Italy) applied in extraction socket.

Treatment:

Drug: Hyaluronic Acid (HA)

Group 3

Active Comparator group

Description:

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).

Treatment:

Drug: Corticosteroid Injection