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

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.

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.

Study Overview

• Status: Completed
• Conditions: Vitamin D Deficiency
• Intervention / Treatment: Procedure: non-surgical periodontal therapy (SRP); Dietary supplement: non-surgical periodontal therapy (SRP)+ Omega-3; Dietary supplement: non-surgical periodontal therapy (SRP)+ Vitamin D

Detailed Description

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

1. Clinical attachment loss (CAL)
2. Plaque index (PI)
3. Gingival index (GI)

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 02
    • Marwa Helal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: non-surgical periodontal therapy (SRP); The CAL PPD and mSBI will be measured for each patient and will be recorded at baseline and 6 weeks; all patients will receive supragingival and sub-gingival plaque and calculus debridement (SRP) with an ultrasonic scaler (Various 350; NSK, Japan) and a manual universal curette (Gracey; Hu-Friday, Chicago, USA) where, conventional scaling and root planning (SRP) to the bottom of the pocket of 4 mm or more; Subgingival saline irrigation will be performed adjunctively to Sub-gingival curettage.	Procedure: non-surgical periodontal therapy (SRP); The CAL PPD and mSBI will be measured for each patient and will be recorded at baseline and 6 weeks; all patients will receive supragingival and sub-gingival plaque and calculus debridement (SRP) with an ultrasonic scaler (Various 350; NSK, Japan) and a manual universal curette (Gracey; Hu-Friday, Chicago, USA) where, conventional scaling and root planning (SRP) to the bottom of the pocket of 4 mm or more; Subgingival saline irrigation will be performed adjunctively to Sub-gingival curettage.; Dietary supplement: non-surgical periodontal therapy (SRP)+ Omega-3; The CAL PPD and mSBI will be measured for each patient and will be recorded at baseline and 6 weeks; all patients will receive supragingival and sub-gingival plaque and calculus debridement (SRP) with an ultrasonic scaler (Various 350; NSK, Japan) and a manual universal curette (Gracey; Hu-Friday, Chicago, USA); Subgingival saline irrigation will be performed adjunctively to Sub-gingival curettage.; Patients will start taking Omega-3 supplements on the day of SRP procedure.; Dietary supplement: non-surgical periodontal therapy (SRP)+ Vitamin D; The CAL PPD and mSBI will be measured for each patient and will be recorded at baseline and 6 weeks; all patients will receive supragingival and sub-gingival plaque and calculus debridement (SRP) with an ultrasonic scaler (Various 350; NSK, Japan) and a manual universal curette (Gracey; Hu-Friday, Chicago, USA) where, conventional scaling and root planning (SRP) to the bottom of the pocket of 4 mm or more; Subgingival saline irrigation will be performed adjunctively to Sub-gingival curettage.; Serum vitamin D levels will be assessed at baseline and 6 weeks after intervention in all groups.
Experimental: non-surgical periodontal therapy (SRP)+ Omega-3; The CAL PPD and mSBI will be measured for each patient and will be recorded at baseline and 6 weeks; patients will receive supragingival and sub-gingival plaque and calculus debridement (SRP) with an ultrasonic scaler (Various 350; NSK, Japan) and a manual universal curette (Gracey; Hu-Friday, Chicago, USA); Subgingival saline irrigation will be performed adjunctively to Sub-gingival curettage.; Patients will start taking Omega-3 supplements on the day of SRP procedure.	Procedure: non-surgical periodontal therapy (SRP); The CAL PPD and mSBI will be measured for each patient and will be recorded at baseline and 6 weeks; all patients will receive supragingival and sub-gingival plaque and calculus debridement (SRP) with an ultrasonic scaler (Various 350; NSK, Japan) and a manual universal curette (Gracey; Hu-Friday, Chicago, USA) where, conventional scaling and root planning (SRP) to the bottom of the pocket of 4 mm or more; Subgingival saline irrigation will be performed adjunctively to Sub-gingival curettage.; Dietary supplement: non-surgical periodontal therapy (SRP)+ Omega-3; The CAL PPD and mSBI will be measured for each patient and will be recorded at baseline and 6 weeks; all patients will receive supragingival and sub-gingival plaque and calculus debridement (SRP) with an ultrasonic scaler (Various 350; NSK, Japan) and a manual universal curette (Gracey; Hu-Friday, Chicago, USA); Subgingival saline irrigation will be performed adjunctively to Sub-gingival curettage.; Patients will start taking Omega-3 supplements on the day of SRP procedure.; Dietary supplement: non-surgical periodontal therapy (SRP)+ Vitamin D; The CAL PPD and mSBI will be measured for each patient and will be recorded at baseline and 6 weeks; all patients will receive supragingival and sub-gingival plaque and calculus debridement (SRP) with an ultrasonic scaler (Various 350; NSK, Japan) and a manual universal curette (Gracey; Hu-Friday, Chicago, USA) where, conventional scaling and root planning (SRP) to the bottom of the pocket of 4 mm or more; Subgingival saline irrigation will be performed adjunctively to Sub-gingival curettage.; Serum vitamin D levels will be assessed at baseline and 6 weeks after intervention in all groups.
Experimental: non-surgical periodontal therapy (SRP)+ Vitamin D; Patients will start taking Omega-3 supplements on the day of SRP procedure.; Serum vitamin D levels will be assessed at baseline and 6 weeks after intervention in all groups.	Procedure: non-surgical periodontal therapy (SRP); The CAL PPD and mSBI will be measured for each patient and will be recorded at baseline and 6 weeks; all patients will receive supragingival and sub-gingival plaque and calculus debridement (SRP) with an ultrasonic scaler (Various 350; NSK, Japan) and a manual universal curette (Gracey; Hu-Friday, Chicago, USA) where, conventional scaling and root planning (SRP) to the bottom of the pocket of 4 mm or more; Subgingival saline irrigation will be performed adjunctively to Sub-gingival curettage.; Dietary supplement: non-surgical periodontal therapy (SRP)+ Omega-3; The CAL PPD and mSBI will be measured for each patient and will be recorded at baseline and 6 weeks; all patients will receive supragingival and sub-gingival plaque and calculus debridement (SRP) with an ultrasonic scaler (Various 350; NSK, Japan) and a manual universal curette (Gracey; Hu-Friday, Chicago, USA); Subgingival saline irrigation will be performed adjunctively to Sub-gingival curettage.; Patients will start taking Omega-3 supplements on the day of SRP procedure.; Dietary supplement: non-surgical periodontal therapy (SRP)+ Vitamin D; The CAL PPD and mSBI will be measured for each patient and will be recorded at baseline and 6 weeks; all patients will receive supragingival and sub-gingival plaque and calculus debridement (SRP) with an ultrasonic scaler (Various 350; NSK, Japan) and a manual universal curette (Gracey; Hu-Friday, Chicago, USA) where, conventional scaling and root planning (SRP) to the bottom of the pocket of 4 mm or more; Subgingival saline irrigation will be performed adjunctively to Sub-gingival curettage.; Serum vitamin D levels will be assessed at baseline and 6 weeks after intervention in all groups.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical attachment loss (CAL)	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.	Day 0 - month 3- month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plaque index (PI)	• through the Silness & Loe plaque index score: score the thickness of plaque, sum the scores, and divide by the number of surfaces/teeth to get an average score. 0: no plaque - 1: thin film on gingival margin - 2: visible plaque in pocket and on gingival margin - 3: dense plaque in pocket and on gingival margin	Day 0 - month 3- month 6
Gingival index (GI)	through the modified Loe & Silness score by assigning a score to each site based on these criteria as follows. 0: normal gingiva - 2: mild inflammation (slight color change, slight edema, no bleeding on probing) - 3: moderate inflammation (redness-edema-glazing-bleeding on probing) - 3: severe inflammation (marked redness, edema, spontaneous bleeding, or ulceration).	Day 0- month 3- month 6

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2025
• Primary Completion (Actual): June 1, 2025
• Study Completion (Actual): December 1, 2025

Study Registration Dates

• First Submitted: October 21, 2024
• First Submitted That Met QC Criteria: October 21, 2024
• First Posted (Actual): October 23, 2024

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Nutritional and Metabolic Diseases; Vitamin D Deficiency; Physiological Effects of Drugs; Bone Density Conservation Agents; Micronutrients; Vitamins; Vitamin D
• Other Study ID Numbers: 531024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No