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

NCT06654063 | Recruiting

• 1 other identifier: 531024
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitamin D Deficiency

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Plaque index (PI)

  Day 0 - month 3- month 6

• Gingival index (GI)

  Day 0- month 3- month 6

Study Arms (3)

non-surgical periodontal therapy (SRP)

ACTIVE COMPARATOR

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

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

EXPERIMENTAL

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

non-surgical periodontal therapy (SRP)+ Vitamin D

EXPERIMENTAL

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

Interventions

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); non-surgical periodontal therapy (SRP)+ Omega-3; non-surgical periodontal therapy (SRP)+ Vitamin D

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); non-surgical periodontal therapy (SRP)+ Omega-3; non-surgical periodontal therapy (SRP)+ Vitamin D

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.

non-surgical periodontal therapy (SRP); non-surgical periodontal therapy (SRP)+ Omega-3; non-surgical periodontal therapy (SRP)+ Vitamin D

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Marwa Helal

Cairo, 02, Egypt

RECRUITING

MeSH Terms

Conditions

Vitamin D Deficiency

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Central Study Contacts

Marwa Helal

CONTACT

01125141408; marwa.helal@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer Periodontology and implantology

Study Record Dates

• First Submitted: October 21, 2024
• First Posted: October 23, 2024
• Study Start: April 1, 2025
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 12, 2025

Record last verified: 2025-12

Locations

EG (1)