Diabetes MellitusPhase 4NCT06637384
Effect of Hyaluronic Acid and Single Dose Corticosteroid Injection to Improve Wound Healing in Controlled Diabetic Patients Post Tooth Extraction.
A Phase 4 study testing Hyaluronic Acid (HA) and Corticosteroid Injection in people with Diabetes Mellitus and Wound Healing Delayed, run by Rimsha Rasheed at 1 site in Pakistan.
Trial summary
The goal of this clinical trial is to learn if hyaluronic acid and corticosteroid improves wound healing in diabetic patients after oral extraction. Read more about this study
- Who is it for?
- Ages 25 to 55 years
- Conditions the study is for
- Diabetes Mellitus, Wound Healing Delayed
- What is being tested?
- Hyaluronic Acid (HA) and Corticosteroid Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2024to 31 Jul 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- • 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.
Who cannot join
- • 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 locations and contacts
1 site in 1 country.
Pakistan1 site
Department of Oral and Maxillofacial Surgery, Madinah Teaching Hospital, Faisalabad
Faisalabad, Punjab Province, 38000
About this study
Official title: 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.
Read the 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
- Conditions
- Diabetes Mellitus, Wound Healing Delayed
- Being tested
- Hyaluronic Acid (HA), Corticosteroid Injection
- Keywords
- Wound healing post extraction, Single dose corticosteroid, Diabetes Mellitus, Hyaluronic acid
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic Acid (HA)Drug
Also called 0.2% Hyaluronic acid
Gengigel Gingival Gel 20ml, Ricerfarma, Milan, Italy
Corticosteroid InjectionDrug
Hydrocortisone Sodium Succinate, Cirin Pharmaceuticals, Pakistan
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Drug: Corticosteroid Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start1 Mar 2024
- Primary completion30 Apr 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rimsha Rasheed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rimsha Rasheed, University of Faisalabad
- Investigators
- Rimsha Rasheed, BDS, MPhil Physiology, Principal investigator, The University of Faisalabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06637384
- Sponsor's protocol ID
- Tuf/IRB/293/24
- Status last verified
- Sep 2024
- First submitted
- 9 Oct 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Patient data is kept confidential.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Hyaluronic Acid and Corticosteroid in Post Extraction Wound Healing of Diabetic Patients
- ClinicalTrials.gov ID
- NCT06637384
- Acronym / sponsor ID
- Tuf/IRB/293/24
- Conditions
- Diabetes Mellitus, Wound Healing Delayed
- Keywords
- Wound healing post extraction, Single dose corticosteroid, Diabetes Mellitus, Hyaluronic acid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Rimsha RasheedUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if hyaluronic acid and corticosteroid improves wound healing in diabetic patients after oral extraction.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Drug: Hyaluronic Acid (HA)Patients treated with 0.2 % Hyaluronic acid (Gengigel Gingival Gel 20ml, Ricerfarma, Milan, Italy) applied in extraction socket. |
| Group 3 | Active comparator | Drug: Corticosteroid InjectionThe 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). |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- • Controlled diabetic patients who had random blood glucose levels of 80 to 130 mg/dl, according to World Health Organization.
Key exclusion criteria (7 listed)
- • Patients who declined to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyaluronic Acid (HA)Also: 0.2% Hyaluronic acidGengigel Gingival Gel 20ml, Ricerfarma, Milan, Italy | Drug | Group 2 |
| Corticosteroid InjectionHydrocortisone Sodium Succinate, Cirin Pharmaceuticals, Pakistan | Drug | Group 3 |
Primary outcome
Wound healing
Time frame: 6 days
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Implicates the role of hyaluronic acid in every major wound healing event.Link provided by the sponsor.
- Describes the beneficial role of corticosteroid to reduce post operative pain and inflammation.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Patient data is kept confidential.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rimsha Rasheed, BDS, MPhil Physiology principal investigator
The University of Faisalabad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hyaluronic Acid (HA) and Corticosteroid Injection in people with Diabetes Mellitus and Wound Healing Delayed, run by Rimsha Rasheed at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound healing (time frame: 6 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.