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 | Completed

• 1 other identifier: 391124
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitamin D Deficiency

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 0 - Week 6

Secondary Outcomes (2)

• Probing Pocket Depth (PPD)

  Day 0 - Week 6

• Bleeding on probing (BOP)

  Day 0- Week 6

Study Arms (2)

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.

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.

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 DIETARY_SUPPLEMENT

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

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

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Marwa Helal

Cairo, 02, Egypt

Location

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Photochemotherapy; 1-phenyl-3,3-dimethyltriazene

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy

Study Officials

• Marwa Helal

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer Periodontology and implantology

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: November 21, 2024
• Study Start: March 1, 2025
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: May 26, 2026

Record last verified: 2026-05

Locations

EG (1)