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

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.

Study Overview

• Status: Completed
• Conditions: Vitamin D Deficiency
• Intervention / Treatment: Dietary supplement: non-surgical periodontal therapy (SRP) and Photodynamic therapy (PDT) with systemic vitamin D

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)

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 02
    • Marwa Helal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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: 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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Marwa Helal, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2025
• Primary Completion (Actual): May 1, 2025
• Study Completion (Actual): May 1, 2025

Study Registration Dates

• First Submitted: November 19, 2024
• First Submitted That Met QC Criteria: November 19, 2024
• First Posted (Actual): November 21, 2024

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Nutritional and Metabolic Diseases; Vitamin D Deficiency; Therapeutics; Drug Therapy; Combined Modality Therapy; Phototherapy; 1-phenyl-3,3-dimethyltriazene; Photochemotherapy
• Other Study ID Numbers: 391124

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No