Effects of Omega-3 as an Adjunct to Non-Surgical Periodontal Therapy on Chemerin Level in Periodontitis Patients With Diabetes: A Randomized Clinical Trial
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable diabetes-mellitus
Started Jun 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 15, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2024
CompletedFirst Submitted
Initial submission to the registry
June 9, 2024
CompletedFirst Posted
Study publicly available on registry
June 18, 2024
CompletedJune 18, 2024
June 1, 2024
10 months
June 9, 2024
June 14, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Serum level of chemerin
Serum level of chemerin
6 months
Secondary Outcomes (4)
periodontal clinical parameters
6 months
hba1c
6 months
GCF level of chemerin
6 months
periodontal clinical parameters
6 months
Study Arms (2)
group I
EXPERIMENTALType 2 Diabetes Mellitus patients with CPD + SRP and Omega-3
group II
ACTIVE COMPARATORType 2 Diabetes Mellitus patients with CPD + SRP
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
British University in Egypt
Cairo, Egypt
Related Publications (1)
Ghalwash D, Ammar A, Hamdy A, El-Gawish A. Impact of the Adjunctive Use of Omega-3 in Periodontitis Patients With Diabetes on Local and Systemic Chemerin Levels: A Randomized Clinical Trial. Int J Dent. 2025 Jul 30;2025:7927250. doi: 10.1155/ijod/7927250. eCollection 2025.
PMID: 40771657DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- lecturer
Study Record Dates
First Submitted
June 9, 2024
First Posted
June 18, 2024
Study Start
June 15, 2023
Primary Completion
April 15, 2024
Study Completion
June 1, 2024
Last Updated
June 18, 2024
Record last verified: 2024-06