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NCT Number: NCT06654063

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.

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Key information

Conditions

Vitamin D Deficiency Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

25 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marwa Helal

Cairo, 02, Egypt

About this study

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

  • Clinical attachment loss (CAL)
  • Plaque index (PI)
  • Gingival index (GI)

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

non-surgical periodontal therapy (SRP)

Procedure
  • 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.

non-surgical periodontal therapy (SRP)+ Omega-3

Dietary Supplement
  • 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.

non-surgical periodontal therapy (SRP)+ Vitamin D

Dietary Supplement
  • 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.

Primary outcomes

  1. clinical attachment loss (CAL)

    Time frame: Day 0 - month 3- month 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 outcomes

  1. Plaque index (PI)

    Time frame: Day 0 - month 3- month 6

    • 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

  2. Gingival index (GI)

    Time frame: Day 0- month 3- month 6

    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).

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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.

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Oct 23, 2024
Registry last updated
May 22, 2026

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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