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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05122117
• Other study ID #: 1234786
• Status: Completed
• Phase: N/A
• Start date: March 4, 2019
• Est. completion date: March 2, 2020

Study information

• Verified date: November 2021
• Source: King Saud University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2, 2020
• Est. primary completion date: January 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Chronic Periodontitis
• Periodontitis
• Rheumatoid Arthritis

Intervention

Device:
• 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.

Procedure:
• 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.

Locations

Country	Name	City	State
Saudi Arabia	King Saud University	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
Zohaib Akram

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Probing depth	Measurement of consecutive millimeter markings of the periodontal pocket depth	12 weeks
Primary	Clinical attachment level	Measurement of periodontal pocket depth along with recession	12 weeks
Secondary	Bleeding on probing	Presence or absence of bleeding indicated as '1' or '0', respectively	12 weeks
Secondary	Plaque index	Presence or absence of plaque indicated as '1' or '0', respectively	12 weeks
Secondary	Interleukin-6	Assessment from gingival crevicular fluid	12 weeks
Secondary	Tumor necrosis factor alpha	Assessment from gingival crevicular fluid	12 weeks