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Completed

NCT Number: 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

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.

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Key information

Age range

25 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

British University in Egypt

Cairo, Egypt

About this study

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:

  • Each patient had received an initial phase of detailed instruction in self-performed plaque control measures using soft toothbrush and interdental cleansing devices.
  • Full mouth SRP using ultrasonic scaler and hand instruments under local anesthesia was performed to each patient in two sessions.
  • Chlorehexidine CHX mouthwash was prescribed for patients to be used twice daily.
  • For each patient, follow up visits every 2 weeks were done to ensure plaque control.
  • Patients were re- examined after 2 weeks (baseline), 3 and 6 months

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OMega 3

Drug

SRP + OMEGA 3

SRP alone

Procedure

Scaling and root planning

Primary outcomes

  1. Serum level of chemerin

    Time frame: 6 months

    Serum level of chemerin

Secondary outcomes

  1. periodontal clinical parameters

    Time frame: 6 months

    PD in mm

  2. hba1c

    Time frame: 6 months

    Glycated Heamoglobin

  3. GCF level of chemerin

    Time frame: 6 months

    GCF level of chemerin

  4. periodontal clinical parameters

    Time frame: 6 months

    CAL in mm

Sponsors and collaborators

Lead sponsor

British University In Egypt

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 18, 2024
Registry last updated
Jun 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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