Vitamin D DeficiencyNCT06654063
Clinical Assessment of Adjunctive Omega-3 Versus Vitamin D Daily Supplements on Active Periodontal Therapy With Stage II Grade B Periodontitis Patients
A study testing non-surgical periodontal therapy (SRP), non-surgical periodontal therapy (SRP)+ Omega-3 and non-surgical periodontal therapy (SRP)+ Vitamin D in people with Vitamin D Deficiency, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- non-surgical periodontal therapy (SRP), non-surgical periodontal therapy (SRP)+ Omega-3 and non-surgical periodontal therapy (SRP)+ Vitamin D
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2025to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- • 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.
Show all 11Show fewer
- 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.
Who cannot join
- • 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 locations and contacts
1 site in 1 country.
About this study
Official 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.
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.
Read the detailed description
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)
- Conditions
- Vitamin D Deficiency
- Being tested
- non-surgical periodontal therapy (SRP), non-surgical periodontal therapy (SRP)+ Omega-3, non-surgical periodontal therapy (SRP)+ Vitamin D
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-surgical periodontal therapy (SRP)Procedure or surgery
- 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-3Dietary 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 DDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Procedure: non-surgical periodontal therapy (SRP); Dietary Supplement: non-surgical periodontal therapy (SRP)+ Omega-3; Dietary Supplement: non-surgical periodontal therapy (SRP)+ Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0 - month 3- month 6
Secondary outcomes (2)
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
Measured: Day 0 - month 3- month 6
Gingival index (GI)
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).
Measured: Day 0- month 3- month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start1 Apr 2025
- Primary completion1 Jun 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Helal, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06654063
- Sponsor's protocol ID
- 531024
- Status last verified
- May 2026
- First submitted
- 21 Oct 2024
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT06654063
- Acronym / sponsor ID
- 531024
- Conditions
- Vitamin D Deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 23 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| non-surgical periodontal therapy (SRP) | Active comparator | Procedure: non-surgical periodontal therapy (SRP), Dietary Supplement: non-surgical periodontal therapy (SRP)+ Omega-3, Dietary Supplement: 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. |
| non-surgical periodontal therapy (SRP)+ Omega-3 | Experimental | Procedure: non-surgical periodontal therapy (SRP), Dietary Supplement: non-surgical periodontal therapy (SRP)+ Omega-3, Dietary Supplement: 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 * 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 | Experimental | Procedure: non-surgical periodontal therapy (SRP), Dietary Supplement: non-surgical periodontal therapy (SRP)+ Omega-3, Dietary Supplement: 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. |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- • Systemic healthy patients
Key exclusion criteria (4 listed)
- • Patients taking Omega- 3 or Vitamin D as a nutritional supplement were excluded from the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | 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* 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. | Dietary supplement | 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* 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. | Dietary supplement | non-surgical periodontal therapy (SRP), non-surgical periodontal therapy (SRP)+ Omega-3, non-surgical periodontal therapy (SRP)+ Vitamin D |
Primary outcome
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.
2 secondary outcomes
Plaque index (PI)
Time frame: Day 0 - month 3- month 6
Gingival index (GI)
Time frame: Day 0- month 3- month 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
Related trials for Vitamin D Deficiency
RecruitingPhase 1/2
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
Not yet recruitingPhase 2
REducing Systemic Inflammation With LOw-dose Colchicine to ImproVE Cardiovascular Calcification in Chronic Kidney Disease: A Pilot Randomized Open-Label Trial
Chronic Kidney Disease Mineral and Bone Disorder, Cognitive Function
Recruiting
Role of Vitamin D Supplementation in Children With Irritable Bowel Syndrome
Irritable Bowel Syndrome (IBS), Vitamin D Deficiency
RecruitingObservational study
Post Marketing Surveillance Study to Observe Safety and Effectiveness of CRYSVITA® in S. Korean Patients
FGF23-related Hypophosphataemic Rickets and Osteomalacia
Not yet recruiting
Effect of Vitamin D Supplementation Added to Iron Therapy in Children With Iron Deficiency Anemia
Iron Deficiency Anemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing non-surgical periodontal therapy (SRP), non-surgical periodontal therapy (SRP)+ Omega-3 and non-surgical periodontal therapy (SRP)+ Vitamin D in people with Vitamin D Deficiency, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical attachment loss (CAL) (time frame: Day 0 - month 3- month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.