Clinical trial NCT06463535: Effects of Omega-3 as an Adjunct to Non-Surgical Periodontal Therapy on Chemerin Level in Periodontitis Patients With Diabetes: A Randomized Clinical Trial
Official title: Effects of Omega-3 as an Adjunct to Non-Surgical Periodontal Therapy on Chemerin Level
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Periodontal Diseases
Lead sponsor: British University In Egypt
Sponsor class: OTHER
First posted: 2024-06-18
Enrollment: 30
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Serum level of chemerin
timeFrame: 6 months
Secondary outcomes:
measure: periodontal clinical parameters
timeFrame: 6 months
measure: hba1c
timeFrame: 6 months
measure: GCF level of chemerin
timeFrame: 6 months
measure: periodontal clinical parameters
timeFrame: 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: British University in Egypt
Study officials:
References: