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

Cairo University (CU)

Status: Enrolling

Conditions: Vitamin D Deficiency

Treatments: Procedure: non-surgical periodontal therapy (SRP); Dietary Supplement: non-surgical periodontal therapy (SRP)+ Vitamin D; Dietary Supplement: non-surgical periodontal therapy (SRP)+ Omega-3

Study type: Interventional

Funder types: Other

Identifiers

NCT06654063

531024

Details and patient eligibility

About

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.

Full 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)

Enrollment: 72 estimated patients

Sex: All

Ages: 25 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

72 participants in 3 patient groups

non-surgical periodontal therapy (SRP)

Active Comparator group

Description:

* 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.

Treatment:

Dietary Supplement: non-surgical periodontal therapy (SRP)+ Omega-3

Dietary Supplement: non-surgical periodontal therapy (SRP)+ Vitamin D

Procedure: non-surgical periodontal therapy (SRP)

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

Experimental group

Description:

* 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.

Treatment:

Dietary Supplement: non-surgical periodontal therapy (SRP)+ Omega-3

Dietary Supplement: non-surgical periodontal therapy (SRP)+ Vitamin D

Procedure: non-surgical periodontal therapy (SRP)

non-surgical periodontal therapy (SRP)+ Vitamin D

Experimental group

Description:

* 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.

Treatment:

Dietary Supplement: non-surgical periodontal therapy (SRP)+ Omega-3

Dietary Supplement: non-surgical periodontal therapy (SRP)+ Vitamin D

Procedure: non-surgical periodontal therapy (SRP)