Clinical Assessment of Adjunctive Omega-3 Versus Vitamin... | NCT06654063

NCT06654063

Status Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

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 Outcomes

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

Eligibility Module

ID	Term
D001361	Avitaminosis
D003677	Deficiency Diseases
D044342	Malnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases