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

NCT06700122 — Not applicable, Completed, 24 participants, Cairo University

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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.

RegistryNCT06700122
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: double, treatment
Enrollment24 (Actual)
SponsorCairo University (Other)
ConditionsVitamin D Deficiency
Interventionsnon-surgical periodontal therapy (SRP) and Photodynamic therapy (PDT) with systemic vitamin D (Dietary supplement)
Datesstart 2025-03-01, primary completion 2025-05-01, completion 2025-05-01, first posted 2024-11-21, last updated 2026-05-26
Locations1 site in Egypt

Related Papers Related Patents Related Grants Related Experts
All trials for Vitamin D Deficiency All trials of non-surgical periodontal therapy (SRP) and Photodynamic therapy (PDT) with systemic vitamin D

-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.

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+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

1. Clinical attachment loss (CAL)
2. Probing pocket depth (PPD)
3. Bleeding on probing (BOP)

+Arms and interventions

ArmTypeInterventionsDescription
non-surgical periodontal therapy (SRP) and Photodynamic therapy (PDT) onlyActive comparatorDietary 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 DExperimentalDietary 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.
  • non-surgical periodontal therapy (SRP) and Photodynamic therapy (PDT) with systemic vitamin D (Dietary supplement): non-surgical periodontal therapy (SRP) and Photodynamic therapy (PDT) with systemic vitamin D

+Outcome measures

Primary outcomes

  • Clinical attachment level (CAL) [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.

Secondary outcomes

  • Probing Pocket Depth (PPD) [Day 0 - Week 6]: PPD will be measured form free gingival margin (FGM) to the depth of the pocket using UNC periodontal probe.
  • Bleeding on probing (BOP) [Day 0- Week 6]: Assessment after 30 seconds after gentle brushing of the sulcus with a periodontal probe, measurement quadrant

+Eligibility

Sex: All, ages: 18 Years to 50 Years, accepts healthy volunteers

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.
* 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.
* 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

Exclusion Criteria:

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.

+Locations (1)

FacilityCityCountryStatus
Marwa HelalCairoEgypt

+Investigators