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

NCT ID: NCT06654063

Last Updated: 2025-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-01

Study Completion Date

2025-12-01

Brief Summary

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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.

Detailed Description

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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)

Conditions

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Vitamin D Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

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

Intervention Type 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)

Intervention Type 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)+ Vitamin D

Intervention Type 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)+ 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.

Group Type EXPERIMENTAL

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

Intervention Type 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)

Intervention Type 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)+ Vitamin D

Intervention Type 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)+ 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.

Group Type EXPERIMENTAL

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

Intervention Type 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)

Intervention Type 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)+ Vitamin D

Intervention Type 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.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

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.

Intervention Type PROCEDURE

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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Marwa Helal

Lecturer Periodontology and implantology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Marwa Helal

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Marwa Helal

Role: CONTACT

01125141408

Other Identifiers

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531024

Identifier Type: -

Identifier Source: org_study_id

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