Vitamin D DeficiencyNCT06700122
Clinical Comparative Evaluation of the Use of Photodynamic Therapy in Conjunction With the Use of Vitamin D in Management Stage II Grade B Periodontitis Patients
A study testing non-surgical periodontal therapy (SRP) and Photodynamic therapy (PDT) with systemic vitamin D in people with Vitamin D Deficiency, run by Cairo University at 1 site in Egypt.
Trial summary
Clinical Comparative Evaluation of the use of Photodynamic Therapy in conjunction with the use of Vitamin D in management Stage II Grade B Periodontitis Patients: A Randomized controlled clinical trial. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- non-surgical periodontal therapy (SRP) and Photodynamic therapy (PDT) with systemic vitamin D
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2025to 1 May 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 18 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.
- Patients with interdental clinical attachment loss (CAL) of 3-4 mm with radiographic evidence of bone loss extending to coronal third of the root.
- Radiographic bone loss (RBL) will be diagnosed using periapical parallel technique using 6 radiographic images for full mouth (3- radiographic images for maxillary arch and 3- radiographic images for mandibular arch) including anterior, canine region and posterior teeth at baseline for diagnosis.
- No history of previous periodontal therapy.
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- 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
Who cannot join
- Patients taking 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 Comparative Evaluation of the Use of Photodynamic Therapy in Conjunction With the Use of Vitamin D in Management Stage II Grade B Periodontitis Patients: A Randomized Controlled Clinical Trial.
Clinical Comparative Evaluation of the use of Photodynamic Therapy in conjunction with the use of Vitamin D in management Stage II Grade B Periodontitis Patients: A Randomized controlled clinical trial.
Read the detailed description
This randomized clinical trial evaluates the effect of Photodynamic therapy alone with SRP versus Photodynamic therapy with SRP and Vitamin D regarding Clinical evaluation
- Clinical attachment loss (CAL)
- Probing pocket depth (PPD)
- Bleeding on probing (BOP)
- Conditions
- Vitamin D Deficiency
- Being tested
- non-surgical periodontal therapy (SRP) and Photodynamic therapy (PDT) with systemic 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) and Photodynamic therapy (PDT) with systemic vitamin DDietary supplement
non-surgical periodontal therapy (SRP) and Photodynamic therapy (PDT) with systemic vitamin D
| Study group | Role | What they receive |
|---|---|---|
| non-surgical periodontal therapy (SRP) and Photodynamic therapy (PDT) only | Active comparator | * all patients will receive supragingival and sub-gingival plaque and calculus debridement (SRP) with an ultrasonic scaler and a manual universal curette where, conventional scaling and root planning (SRP) to the bottom of the pocket of 4 mm or more will be done to preserve any residual fibers attached and to avoid unintentional curettage and prevent any possible shrinkage.
* Subgingival saline irrigation will be performed adjunctively to Sub-gingival curettage.
* All teeth will be polished with a rubber cup. Photodynamic therapy will be done with a blue halogen curing light of wavelength 470 nm with intensity 620 mW/cm2, a continuous mode for 5 min.
* The photosensitizer will be applied to the bottom of the periodontal pocket with the help of an applicator. After 5 min, the photosensitizer will be rinsed with saline and will be exposed to on blue halogen curing light "0" day, which will be repeated on 7th and 21st day. Receives: Dietary Supplement: non-surgical periodontal therapy (SRP) and Photodynamic therapy (PDT) with systemic vitamin D |
| non-surgical periodontal therapy (SRP) and Photodynamic therapy (PDT) with systemic vitamin D | Experimental | * all patients will receive supragingival and sub-gingival plaque and calculus debridement (SRP) with an ultrasonic scaler and a manual universal curette where, conventional scaling and root planning (SRP) to the bottom of the pocket of 4 mm or more will be done
* Subgingival saline irrigation will be performed adjunctively to Sub-gingival curettage.
* All teeth will be polished with a rubber cup. Photodynamic therapy will be done with a blue halogen curing light of wavelength 470 nm with intensity 620 mW/cm2, a continuous mode for 5 min.
* The photosensitizer will be applied to the bottom of the periodontal pocket with the help of an applicator. After 5 min, the photosensitizer will be rinsed with saline and will be exposed to on blue halogen curing light "0" day, which will be repeated on 7th and 21st day. Serum vitamin D levels will be assessed by blood sample at baseline and 6 weeks after intervention in test group. Receives: Dietary Supplement: non-surgical periodontal therapy (SRP) and Photodynamic therapy (PDT) with systemic vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical attachment level (CAL)
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 - Week 6
Secondary outcomes (2)
Probing Pocket Depth (PPD)
PPD will be measured form free gingival margin (FGM) to the depth of the pocket using UNC periodontal probe.
Measured: Day 0 - Week 6
Bleeding on probing (BOP)
Assessment after 30 seconds after gentle brushing of the sulcus with a periodontal probe, measurement quadrant
Measured: Day 0- Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start1 Mar 2025
- Primary completion1 May 2025
- Study completion1 May 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Helal, Cairo University
- Investigators
- Marwa Helal, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06700122
- Sponsor's protocol ID
- 391124
- Status last verified
- May 2026
- First submitted
- 19 Nov 2024
- Last updated
- 26 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 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Comparative Evaluation of the Use of Photodynamic Therapy in Conjunction With the Use of Vitamin D in Management Stage II Grade B Periodontitis Patients: A Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT06700122
- Acronym / sponsor ID
- 391124
- Conditions
- Vitamin D Deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 21 Nov 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 Comparative Evaluation of the use of Photodynamic Therapy in conjunction with the use of Vitamin D in management Stage II Grade B Periodontitis Patients: A Randomized controlled clinical trial.
Detailed description
This randomized clinical trial evaluates the effect of Photodynamic therapy alone with SRP versus Photodynamic therapy with SRP and Vitamin D regarding Clinical evaluation
- Clinical attachment loss (CAL)
- Probing pocket depth (PPD)
- Bleeding on probing (BOP)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| non-surgical periodontal therapy (SRP) and Photodynamic therapy (PDT) only | Active comparator | Dietary Supplement: non-surgical periodontal therapy (SRP) and Photodynamic therapy (PDT) with systemic vitamin D* all patients will receive supragingival and sub-gingival plaque and calculus debridement (SRP) with an ultrasonic scaler and a manual universal curette where, conventional scaling and root planning (SRP) to the bottom of the pocket of 4 mm or more will be done to preserve any residual fibers attached and to avoid unintentional curettage and prevent any possible shrinkage. * Subgingival saline irrigation will be performed adjunctively to Sub-gingival curettage. * All teeth will be polished with a rubber cup. Photodynamic therapy will be done with a blue halogen curing light of wavelength 470 nm with intensity 620 mW/cm2, a continuous mode for 5 min. * The photosensitizer will be applied to the bottom of the periodontal pocket with the help of an applicator. After 5 min, the photosensitizer will be rinsed with saline and will be exposed to on blue halogen curing light "0" day, which will be repeated on 7th and 21st day. |
| non-surgical periodontal therapy (SRP) and Photodynamic therapy (PDT) with systemic vitamin D | Experimental | Dietary Supplement: non-surgical periodontal therapy (SRP) and Photodynamic therapy (PDT) with systemic vitamin D* all patients will receive supragingival and sub-gingival plaque and calculus debridement (SRP) with an ultrasonic scaler and a manual universal curette where, conventional scaling and root planning (SRP) to the bottom of the pocket of 4 mm or more will be done * Subgingival saline irrigation will be performed adjunctively to Sub-gingival curettage. * All teeth will be polished with a rubber cup. Photodynamic therapy will be done with a blue halogen curing light of wavelength 470 nm with intensity 620 mW/cm2, a continuous mode for 5 min. * The photosensitizer will be applied to the bottom of the periodontal pocket with the help of an applicator. After 5 min, the photosensitizer will be rinsed with saline and will be exposed to on blue halogen curing light "0" day, which will be repeated on 7th and 21st day. Serum vitamin D levels will be assessed by blood sample at baseline and 6 weeks after intervention in test group. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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.
- Patients with interdental clinical attachment loss (CAL) of 3-4 mm with radiographic evidence of bone loss extending to coronal third of the root.
- Radiographic bone loss (RBL) will be diagnosed using periapical parallel technique using 6 radiographic images for full mouth (3- radiographic images for maxillary arch and 3- radiographic images for mandibular arch) including anterior, canine region and posterior teeth at baseline for diagnosis.
Key exclusion criteria (4 listed)
- Patients taking 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.
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) and Photodynamic therapy (PDT) with systemic vitamin Dnon-surgical periodontal therapy (SRP) and Photodynamic therapy (PDT) with systemic vitamin D | Dietary supplement | non-surgical periodontal therapy (SRP) and Photodynamic therapy (PDT) only, non-surgical periodontal therapy (SRP) and Photodynamic therapy (PDT) with systemic vitamin D |
Primary outcome
Clinical attachment level (CAL)
Time frame: Day 0 - Week 6
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
Probing Pocket Depth (PPD)
Time frame: Day 0 - Week 6
Bleeding on probing (BOP)
Time frame: Day 0- Week 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 26 May 2026.
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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.
Marwa Helal principal investigator
Cairo University
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) and Photodynamic therapy (PDT) with systemic 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 26 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 level (CAL) (time frame: Day 0 - Week 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 26 May 2026.