Rheumatoid ArthritisNCT05122117
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
A study testing Methylene blue mediated Photodynamic therapy and Non-surgical periodontal therapy in people with Rheumatoid Arthritis and Chronic Periodontitis, run by Zohaib Akram at 1 site in Saudi Arabia.
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. Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Rheumatoid Arthritis, Chronic Periodontitis
- What is being tested?
- Methylene blue mediated Photodynamic therapy and Non-surgical periodontal therapy
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 4 Mar 2019to 2 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Methylene blue mediated Photodynamic therapy, Non-surgical periodontal therapy
- Keywords
- photodynamic therapy, biomarkers, inflammation, Rheumatoid arthritis, chronic periodontitis
- Medical subject headings
- Arthritis, Rheumatoid, Chronic Periodontitis, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylene blue mediated Photodynamic therapyDevice
Also called 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.
Non-surgical periodontal therapyProcedure or surgery
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| Methylene blue mediated photodynamic therapy | Experimental | 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. Receives: Device: Methylene blue mediated Photodynamic therapy; Procedure: Non-surgical periodontal therapy |
| Scaling and root planing | Placebo comparator | 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. Receives: Procedure: Non-surgical periodontal therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing depth
Measurement of consecutive millimeter markings of the periodontal pocket depth
Measured: 12 weeks
Clinical attachment level
Measurement of periodontal pocket depth along with recession
Measured: 12 weeks
Secondary outcomes (4)
Bleeding on probing
Presence or absence of bleeding indicated as '1' or '0', respectively
Measured: 12 weeks
Plaque index
Presence or absence of plaque indicated as '1' or '0', respectively
Measured: 12 weeks
Interleukin-6
Assessment from gingival crevicular fluid
Measured: 12 weeks
Tumor necrosis factor alpha
Assessment from gingival crevicular fluid
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2021
- Study start4 Mar 2019
- Primary completion15 Jan 2020
- Study completion2 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zohaib Akram
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zohaib Akram, King Saud University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05122117
- Sponsor's protocol ID
- 1234786
- Status last verified
- Nov 2021
- First submitted
- 3 Nov 2021
- Last updated
- 16 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05122117
- Acronym / sponsor ID
- 1234786
- Conditions
- Rheumatoid Arthritis, Chronic Periodontitis
- Keywords
- photodynamic therapy, biomarkers, inflammation, Rheumatoid arthritis, chronic periodontitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Zohaib AkramUniversity, hospital or other
- Study start
- 4 Mar 2019 (actual)
- Primary completion
- 15 Jan 2020 (actual)
- Study completion
- 2 Mar 2020 (actual)
- First posted
- 16 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methylene blue mediated photodynamic therapy | Experimental | Device: Methylene blue mediated Photodynamic therapy, Procedure: Non-surgical periodontal therapyMethylene 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. |
| Scaling and root planing | Placebo comparator | Procedure: Non-surgical periodontal therapyA 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. |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methylene blue mediated Photodynamic therapyAlso: Photodynamic therapyMethylene 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. | Device | Methylene blue mediated photodynamic therapy |
| Non-surgical periodontal therapyAlso: Scaling and root planingA 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. | Procedure or surgery | Methylene blue mediated photodynamic therapy, Scaling and root planing |
Primary outcome
Probing depth
Time frame: 12 weeks
Measurement of consecutive millimeter markings of the periodontal pocket depth
Clinical attachment level
Time frame: 12 weeks
Measurement of periodontal pocket depth along with recession
4 secondary outcomes
Bleeding on probing
Time frame: 12 weeks
Plaque index
Time frame: 12 weeks
Interleukin-6
Time frame: 12 weeks
Tumor necrosis factor alpha
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Methylene blue mediated Photodynamic therapy and Non-surgical periodontal therapy in people with Rheumatoid Arthritis and Chronic Periodontitis, run by Zohaib Akram at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probing depth (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2021.