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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06463535
• Other study ID #: BU7720
• Status: Completed
• Phase: N/A
• Start date: June 15, 2023
• Est. completion date: June 1, 2024

Study information

• Verified date: June 2024
• Source: British University In Egypt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 1, 2024
• Est. primary completion date: April 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Periodontal Diseases

Intervention

Drug:
• Omega 3
SRP + OMEGA 3

Procedure:
• SRP alone
Scaling and root planning

Locations

Country	Name	City	State
Egypt	British University in Egypt	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
British University In Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum level of chemerin	Serum level of chemerin	6 months
Secondary	periodontal clinical parameters	PD in mm	6 months
Secondary	hba1c	Glycated Heamoglobin	6 months
Secondary	GCF level of chemerin	GCF level of chemerin	6 months
Secondary	periodontal clinical parameters	CAL in mm	6 months