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

NCT06637384 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: Tuf/IRB/293/24
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus; Wound Healing Delayed

Keywords

Wound healing post extraction, Single dose corticosteroid, Diabetes Mellitus, Hyaluronic acid

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

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.

Drug: Hyaluronic Acid (HA)

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).

Drug: Corticosteroid Injection

Interventions

Hyaluronic Acid (HA) DRUG

Gengigel Gingival Gel 20ml, Ricerfarma, Milan, Italy

Also known as: 0.2% Hyaluronic acid

Group 2

Corticosteroid Injection DRUG

Hydrocortisone Sodium Succinate, Cirin Pharmaceuticals, Pakistan

Group 3

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rimsha Rasheed: lead

Study Sites (1)

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

Faisalabad, Punjab Province, 38000, Pakistan

Location

Related 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.

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Hyaluronic Acid; Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Rimsha Rasheed, BDS, MPhil Physiology

  The University of Faisalabad

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr. Rimsha Rasheed

Study Record Dates

• First Submitted: October 9, 2024
• First Posted: October 15, 2024
• Study Start: March 1, 2024
• Primary Completion: April 30, 2024
• Study Completion: July 31, 2024
• Last Updated: October 15, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)