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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06463535
Enrollment
30
Registered
2024-06-18
Start date
2023-06-15
Completion date
2024-06-01
Last updated
2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Periodontal Diseases

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

Interventions

DRUGOmega 3

SRP + OMEGA 3

PROCEDURESRP alone

Scaling and root planning

Sponsors

British University In Egypt
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
25 Years to 55 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Serum level of chemerin6 monthsSerum level of chemerin

Secondary

MeasureTime frameDescription
periodontal clinical parameters6 monthsPD in mm
hba1c6 monthsGlycated Heamoglobin
GCF level of chemerin6 monthsGCF level of chemerin

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026