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

Cairo University (CU)

Status: Enrolling

Conditions: Vitamin D Deficiency

Treatments: Dietary Supplement: non-surgical periodontal therapy (SRP) and Photodynamic therapy (PDT) with systemic vitamin D

Study type: Interventional

Funder types: Other

Identifiers

NCT06700122

391124

Details and patient eligibility

About

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.

Full 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)

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 2 patient groups

non-surgical periodontal therapy (SRP) and Photodynamic therapy (PDT) only

Active Comparator group

Description:

* 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.

Treatment:

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 group

Description:

* 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.

Treatment:

Dietary Supplement: non-surgical periodontal therapy (SRP) and Photodynamic therapy (PDT) with systemic vitamin D