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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Punjab
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Faisalabad, Punjab, Pakistan, 38000
- Department of Oral and Maxillofacial Surgery, Madinah Teaching Hospital, Faisalabad
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
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)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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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.
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Active Comparator: Group 2
Patients treated with 0.2 % Hyaluronic acid (Gengigel Gingival Gel 20ml, Ricerfarma, Milan, Italy) applied in extraction socket.
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Gengigel Gingival Gel 20ml, Ricerfarma, Milan, Italy
Other Names:
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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).
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Hydrocortisone Sodium Succinate, Cirin Pharmaceuticals, Pakistan
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Wound healing
Time Frame: 6 days
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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
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rimsha Rasheed, BDS, MPhil Physiology, The University of Faisalabad
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Tuf/IRB/293/24
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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