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

NCT ID: NCT06700122

Last Updated: 2025-04-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2025-06-15

Brief 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.

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)

Conditions

Vitamin D Deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

• 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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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

• 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.

Group Type: EXPERIMENTAL

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

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Marwa Helal

Lecturer Periodontology and implantology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marwa Helal

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Marwa Helal

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Marwa Helal

Role: CONTACT

marwa.helal@dentistry.cu.edu.eg

01125141408

Other Identifiers

391124

Identifier Type: -

Identifier Source: org_study_id