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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06463535
Other study ID # BU7720
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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