Impact of Photodynamic Therapy as an Adjunct to Non-surgical Periodontal Treatment on Clinical and Biochemical Parameters Among Patients Having Mild Rheumatoid Arthritis With Periodontitis

NCT ID: NCT05122117

Last Updated: 2021-11-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-04
• Study Completion Date: 2020-03-02

Brief Summary

Purpose: To evaluate the efficacy of photodynamic therapy (PDT) as an adjunct to non-surgical periodontal therapy on the clinical periodontal and biochemical parameters among patients with rheumatoid arthritis (RA) having periodontitis.

Methods: A total of 50 RA patients with periodontitis were included. The subjects were equally divided into two groups: Group A - scaling and root planning (SRP) + PDT; Group B - SRP only, respectively. Plaque score (PS), bleeding on probing (BOP), pocket depth (PD) and clinical attachment level (CAL) were estimated. The biochemical parameters included the assessment of interleukin 6 (IL-6), tumor necrosis factor-alpha (TNF-α) and rheumatoid factors (RFs). Multiple comparisons were established by employing the Bonferroni's post-hoc test for both clinical and laboratory biomarker data. The Mann-Whitney test was used to compute the p-value for intergroup comparisons. For intra-group comparisons, the p-value was computed with the help of Wilcoxon signed ranks test.

Conditions

Rheumatoid Arthritis; Chronic Periodontitis

Keywords

photodynamic therapy; biomarkers; inflammation; Rheumatoid arthritis; chronic periodontitis

Study Design

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

Study Groups

Methylene blue mediated photodynamic therapy

Methylene blue (MB) with a concentration of 10 mg/mL was delivered inside the periodontal pocket. MB was injected inside in the selected periodontal pockets 4 - 6 mm with the help of a blunt needle and left for 1 min. Later, the periodontal pockets were flushed with distilled water for 3 min to remove the excess MB. The diode laser HELBO® TheraLite - Bredent Medical, Germany) of diameter 200 µm was used to deliver the light to initiate the disinfection process. Each participant underwent single session of laser exposure. The laser parameters such as wavelength, spot area, power output and laser energy were set at 660 nm, 0.028 cm2, 60 mW/cm2, and 150 mW, respectively. The laser was subjected for a period of 30 s in each pocket.

Group Type: EXPERIMENTAL

Methylene blue mediated Photodynamic therapy

Intervention Type: DEVICE

Methylene blue (MB) with a concentration of 10 mg/mL was delivered inside the periodontal pocket. MB was injected inside in the selected periodontal pockets 4 - 6 mm with the help of a blunt needle and left for 1 min. Later, the periodontal pockets were flushed with distilled water for 3 min to remove the excess MB. The diode laser HELBO® TheraLite - Bredent Medical, Germany) of diameter 200 µm was used to deliver the light to initiate the disinfection process. Each participant underwent single session of laser exposure. The laser parameters such as wavelength, spot area, power output and laser energy were set at 660 nm, 0.028 cm2, 60 mW/cm2, and 150 mW, respectively. The laser was subjected for a period of 30 s in each pocket.

Non-surgical periodontal therapy

Intervention Type: PROCEDURE

A single session of full-mouth ultrasonic scaling using a sterilized scaler was rendered to the control group. Deep pockets were additionally approached and cleaned by using manual 'After Fives' Gracey curette for root planning (Hu Friedy Gracey After Five Vision curette; HuFriedy, Chicago, USA). This session was followed by a polishing session. A motivational session was conducted where the patients were educated on the importance of maintaining a good oral hygiene by brushing their teeth twice daily followed by the regular use of dental floss and chlorhexidine mouth wash twice daily, respectively.

Scaling and root planing

A single session of full-mouth ultrasonic scaling using a sterilized scaler was rendered to the control group. Deep pockets were additionally approached and cleaned by using manual 'After Fives' Gracey curette for root planning (Hu Friedy Gracey After Five Vision curette; HuFriedy, Chicago, USA). This session was followed by a polishing session. A motivational session was conducted where the patients were educated on the importance of maintaining a good oral hygiene by brushing their teeth twice daily followed by the regular use of dental floss and chlorhexidine mouth wash twice daily, respectively.

Group Type: PLACEBO_COMPARATOR

Non-surgical periodontal therapy

Intervention Type: PROCEDURE

A single session of full-mouth ultrasonic scaling using a sterilized scaler was rendered to the control group. Deep pockets were additionally approached and cleaned by using manual 'After Fives' Gracey curette for root planning (Hu Friedy Gracey After Five Vision curette; HuFriedy, Chicago, USA). This session was followed by a polishing session. A motivational session was conducted where the patients were educated on the importance of maintaining a good oral hygiene by brushing their teeth twice daily followed by the regular use of dental floss and chlorhexidine mouth wash twice daily, respectively.

Interventions

Methylene blue mediated Photodynamic therapy

Methylene blue (MB) with a concentration of 10 mg/mL was delivered inside the periodontal pocket. MB was injected inside in the selected periodontal pockets 4 - 6 mm with the help of a blunt needle and left for 1 min. Later, the periodontal pockets were flushed with distilled water for 3 min to remove the excess MB. The diode laser HELBO® TheraLite - Bredent Medical, Germany) of diameter 200 µm was used to deliver the light to initiate the disinfection process. Each participant underwent single session of laser exposure. The laser parameters such as wavelength, spot area, power output and laser energy were set at 660 nm, 0.028 cm2, 60 mW/cm2, and 150 mW, respectively. The laser was subjected for a period of 30 s in each pocket.

Intervention Type: DEVICE

Non-surgical periodontal therapy

A single session of full-mouth ultrasonic scaling using a sterilized scaler was rendered to the control group. Deep pockets were additionally approached and cleaned by using manual 'After Fives' Gracey curette for root planning (Hu Friedy Gracey After Five Vision curette; HuFriedy, Chicago, USA). This session was followed by a polishing session. A motivational session was conducted where the patients were educated on the importance of maintaining a good oral hygiene by brushing their teeth twice daily followed by the regular use of dental floss and chlorhexidine mouth wash twice daily, respectively.

Intervention Type: PROCEDURE

Other Intervention Names

Photodynamic therapy; Scaling and root planing

Eligibility Criteria

Inclusion Criteria

• Patients aged ≥25 years
• Satisfying the 2010 ACR/EULAR categorization criteria (with active RA with ≥6 joint involvement and under anti-RA medication ≥3 months)
• Patients having >20 teeth diagnosed with generalized (>30% of sites) chronic periodontitis with PD ≥ 4mm and/or CAL ≥ 4mm and vertical bone loss of at least 4 mm on radiography.

Exclusion Criteria

• Patients who had underwent periodontal therapy or antimicrobial therapy in the last 6 months
• Any joint replacement
• Pregnancy/lactating mothers
• Patients having other forms of systemic diseases such as diabetes mellitus, hypertension or acquired immunodeficiency syndrome (AIDS)

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zohaib Akram

OTHER

Sponsor Role: lead

Responsible Party

Zohaib Akram

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

King Saud University

Riyadh, , Saudi Arabia

Countries

Saudi Arabia

Other Identifiers

1234786

Identifier Type: -

Identifier Source: org_study_id