Effects of Omega-3 as an Adjunct to Non-Surgical Periodontal Therapy on Chemerin Level in Periodontitis Patients With Diabetes: A Randomized Clinical Trial

Not Applicable

Completed

• Conditions: Periodontal Diseases; Diabetes Mellitus
• Interventions: Drug: Omega 3; Procedure: SRP alone

• Registration Number: NCT06463535
• Lead Sponsor: British University In Egypt

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.

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

Study Timeline

• Study Start: 2023-06-15
• Primary Completion: 2024-04-15
• Status Verified: 2024-06
• Study Completion: 2024-06-01
• Study First Submitted: 2024-06-09
• Study First Submitted QC: 2024-06-14
• Last Update Submitted: 2024-06-14
• Study First Posted: 2024-06-18
• Last Update Posted: 2024-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patients had type 2 DM for more than 2 years (diagnosed according to the American Diabetes Association criteria), with no other systemic problem. •Subjects had 14 or more natural teeth, of which at least five had a site with probing pocket depth (PPD) ≥ 5 mm and clinical attachment level ≥ 3 mm. From this point, according to the American Academy of Periodontology, subjects with moderate to severe periodontitis were included

Exclusion Criteria

• Pregnant and breastfeeding women, smokers or former smokers, patients with other autoimmune or systemic disease, those patients who took antibiotics in the last 6 months and patients weren't willing to follow our study protocol or plaque regimen

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group I	Omega 3	Type 2 Diabetes Mellitus patients with CPD + SRP and Omega-3
group I	SRP alone	Type 2 Diabetes Mellitus patients with CPD + SRP and Omega-3
group II	SRP alone	Type 2 Diabetes Mellitus patients with CPD + SRP

Primary Outcome Measures

Name	Time	Method
Serum level of chemerin	6 months	Serum level of chemerin

Secondary Outcome Measures

Name	Time	Method
hba1c	6 months	Glycated Heamoglobin
periodontal clinical parameters	6 months	CAL in mm
GCF level of chemerin	6 months	GCF level of chemerin

Trial Locations

Locations (1)

British University in Egypt; 🇪🇬 Cairo, Egypt