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

Effects of Omega-3 as an Adjunct to Non-Surgical Periodontal Therapy on Chemerin Level

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus; Periodontal Diseases
• Intervention / Treatment: Drug: Omega 3; Procedure: SRP alone

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • British University In Egypt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group I; Type 2 Diabetes Mellitus patients with CPD + SRP and Omega-3	Drug: Omega 3; SRP + OMEGA 3; Procedure: SRP alone; Scaling and root planning
Active Comparator: group II; Type 2 Diabetes Mellitus patients with CPD + SRP	Procedure: SRP alone; Scaling and root planning

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum level of chemerin	Serum level of chemerin	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
periodontal clinical parameters	PD in mm	6 months
hba1c	Glycated Heamoglobin	6 months
GCF level of chemerin	GCF level of chemerin	6 months
periodontal clinical parameters	CAL in mm	6 months

Collaborators and Investigators

• Sponsor: British University In Egypt

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2023
• Primary Completion (Actual): April 15, 2024
• Study Completion (Actual): June 1, 2024

Study Registration Dates

• First Submitted: June 9, 2024
• First Submitted That Met QC Criteria: June 14, 2024
• First Posted (Actual): June 18, 2024

Study Record Updates

• Last Update Posted (Actual): June 18, 2024
• Last Update Submitted That Met QC Criteria: June 14, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Periodontal Diseases
• Other Study ID Numbers: BU7720

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No