Ignite Creation Date:
2025-12-24 @ 10:20 PM
Ignite Modification Date:
2026-01-02 @ 10:38 AM
Study NCT ID:
NCT06463535
Status:
COMPLETED
Last Update Posted:
2024-06-18
First Post:
2024-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Omega-3 as an Adjunct to Non-Surgical Periodontal Therapy on Chemerin Level in Periodontitis Patients With Diabetes: A Randomized Clinical Trial
Sponsor:
British University In Egypt
Organization:
Study Overview
Official Title:
Effects of Omega-3 as an Adjunct to Non-Surgical Periodontal Therapy on Chemerin Level
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patient grouping
* Group 1 (Type 2 Diabetes Mellitus patients with CPD + SRP and Omega-3)
* Group 2 (Type 2 Diabetes Mellitus patients with CPD + SRP) different clinical parameters were recorded ; plaque index (PI), gingival index (GI), probing depth (PD), and clinical attachment loss (CAL).
6.Omega-3 poly-unsaturated fatty acids (1000mg) was given as an adjunctive treatment daily for 6 months to group 2, starting 2 weeks after phase 1 therapy.
* Group 1 (Type 2 Diabetes Mellitus patients with CPD + SRP and Omega-3)
* Group 2 (Type 2 Diabetes Mellitus patients with CPD + SRP) different clinical parameters were recorded ; plaque index (PI), gingival index (GI), probing depth (PD), and clinical attachment loss (CAL).
6.Omega-3 poly-unsaturated fatty acids (1000mg) was given as an adjunctive treatment daily for 6 months to group 2, starting 2 weeks after phase 1 therapy.
Detailed Description:
A parallel design randomized clinical trial was performed involving thirty participants divided into two groups, 15 participants in each group selected from the outpatient clinic in Oral medicine and Periodontology department.
Diabetic control was assessed by glycosylated hemoglobin A1c (HbA1c) of blood samples, patients had relatively stable glycemic control, as demonstrated by a difference not exceeding 1% in at least two HbA1c assays over the previous 6 m. HbA1c was assessed at baseline, 3m, and 6m.
Patient grouping
* Group 1 (Type 2 Diabetes Mellitus patients with CPD + SRP and Omega-3)
* Group 2 (Type 2 Diabetes Mellitus patients with CPD + SRP) Periodontal treatment protocol
Group 1 and 2 patients were treated by non-surgical approach in following steps:
1. Each patient had received an initial phase of detailed instruction in self-performed plaque control measures using soft toothbrush and interdental cleansing devices.
2. Full mouth SRP using ultrasonic scaler and hand instruments under local anesthesia was performed to each patient in two sessions.
3. Chlorehexidine CHX mouthwash was prescribed for patients to be used twice daily.
4. For each patient, follow up visits every 2 weeks were done to ensure plaque control.
5. Patients were re- examined after 2 weeks (baseline), 3 and 6 months
Diabetic control was assessed by glycosylated hemoglobin A1c (HbA1c) of blood samples, patients had relatively stable glycemic control, as demonstrated by a difference not exceeding 1% in at least two HbA1c assays over the previous 6 m. HbA1c was assessed at baseline, 3m, and 6m.
Patient grouping
* Group 1 (Type 2 Diabetes Mellitus patients with CPD + SRP and Omega-3)
* Group 2 (Type 2 Diabetes Mellitus patients with CPD + SRP) Periodontal treatment protocol
Group 1 and 2 patients were treated by non-surgical approach in following steps:
1. Each patient had received an initial phase of detailed instruction in self-performed plaque control measures using soft toothbrush and interdental cleansing devices.
2. Full mouth SRP using ultrasonic scaler and hand instruments under local anesthesia was performed to each patient in two sessions.
3. Chlorehexidine CHX mouthwash was prescribed for patients to be used twice daily.
4. For each patient, follow up visits every 2 weeks were done to ensure plaque control.
5. Patients were re- examined after 2 weeks (baseline), 3 and 6 months
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: