Clinical Assessment of Adjunctive Omega-3 Versus Vitamin D Daily Supplements on Active Periodontal Therapy With Stage II Grade B Periodontitis Patients

Not Applicable

Recruiting

• Conditions: Vitamin D Deficiency

• Registration Number: NCT06654063
• Lead Sponsor: Cairo University

Brief Summary

Clinical Assessment of Adjunctive Omega-3 Versus Vitamin D daily Supplements on Active Periodontal Therapy with Stage II Grade B Periodontitis Patients: A Randomized controlled clinical trial.

Detailed Description

This randomized clinical trial evaluates the effect of Omega- 3 versus Vitamin D regarding Clinical evaluation

1. Clinical attachment loss (CAL)

2. Probing pocket depth (PPD)

3. Modified sulcus bleeding index (mSBI)

Study Timeline

• Study First Submitted: 2024-10-21
• Study First Submitted QC: 2024-10-21
• Study First Posted: 2024-10-23
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-13
• Last Update Posted: 2025-04-15
• Study Start: 2025-06-01
• Primary Completion: 2025-06-15
• Study Completion: 2025-06-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• • Systemic healthy patients

  • Patients aged > 25 years
  • Patients suffering from stage II periodontitis with grade B were included in this study, according to 2017 world workshop classification of periodontal disease (Papapanou et al. 2017).
  • Patients with interdental clinical attachment loss (CAL) of 3-4 mm
  • No history of previous periodontal therapy.
  • No taken medications known to interfere healing or periodontal tissue health such as anticonvulsants, calcium channel blockers, or immunosuppressant drugs.
  • No previous periodontal surgery at involved sites.
  • Good oral hygiene and good compliance with the plaque control instructions following initial therapy.
  • Neither taken antibiotics within the last three months nor nonsteroidal anti-inflammatory drugs within the last three months
  • Absence of diseases or conditions that would interfere with wound healing such as diabetes mellitus or coagulation disorders
  • Absence of oral mucosal inflammatory conditions such as aphthous ulcers or lichen planus.

Exclusion Criteria

• • Patients taking Omega- 3 or Vitamin D as a nutritional supplement were excluded from the study

  • Smoking habits
  • Pregnant and lactating mothers
  • Patients who have been received periodontal surgery in the study area during the last 6 months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
clinical attachment loss (CAL)	Day 0 - Week 6	* All clinical outcomes will be measured baseline, 6 weeks after SRP alone and in conjunction with Omega- 3 and Vitamin D.; * CAL will be measured form cemento- enamel junction (CEJ) to the depth of the pocket using UNC periodontal probe.; * It will be recorded at 6 sites per tooth, the recorded readings will be used to generate mean values at each time point.

Secondary Outcome Measures

Name	Time	Method
probing pocket depth (PPD)	Day 0 - Week 6	• PPD will be measured form free gingival margin (FGM) to the depth of the pocket using UNC periodontal probe.
modified sulcus bleeding index (mSBI)	Day 0- Week 6	1. Yes / No (positive/negative) decision; 2. Assessment after 30 seconds after gentle brushing of the sulcus with a periodontal probe, measurement quadrant 1+3 buccal, 2+4 orally; 3. the positive bleeding points; 4. mSBI = ---------------------------------------------------- x 100 measuring points

Trial Locations

Locations (1)

Marwa Helal; 🇪🇬 Cairo, Egypt