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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-01

Study Completion Date

2024-07-31

Brief Summary

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

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Detailed Description

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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

Conditions

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Diabetes Mellitus Wound Healing Delayed

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Group 2

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

Group Type ACTIVE_COMPARATOR

Hyaluronic Acid (HA)

Intervention Type DRUG

Gengigel Gingival Gel 20ml, Ricerfarma, Milan, Italy

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).

Group Type ACTIVE_COMPARATOR

Corticosteroid Injection

Intervention Type DRUG

Hydrocortisone Sodium Succinate, Cirin Pharmaceuticals, Pakistan

Interventions

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Hyaluronic Acid (HA)

Gengigel Gingival Gel 20ml, Ricerfarma, Milan, Italy

Intervention Type DRUG

Corticosteroid Injection

Hydrocortisone Sodium Succinate, Cirin Pharmaceuticals, Pakistan

Intervention Type DRUG

Other Intervention Names

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0.2% Hyaluronic acid

Eligibility Criteria

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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.

Minimum Eligible Age

25 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No