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Clinical Trials/CTRI/2021/04/032704
CTRI/2021/04/032704CompletedPhase 2/3

Comparing the efficacy of photodynamic therapy with 1% malachite green or 1% methylene blue when used adjunctively to scaling and root planing in the treatment of chronic periodontitis

Alina Pauly1 site in 1 country40 target enrollmentStarted: October 4, 2021Last updated:
Conditions

Trial Snapshot

Phase
Phase 2/3
Status
Completed
Sponsor
Enrollment
40
Locations
1
Primary Endpoint
Changes in probing depth(PD) and clinical attachment level(CAL) will be observed in the experimental sites.

Study Overview

Brief Summary

Photodynamic therapy (PDT) is an approach that combines low level laser light with a photosensitizer that binds to the target cells. In the excited state, photosensitizers react with oxygen in the environment generating reactive oxygen species that cause oxidative damage to target cells. Thus, PDT can be an alternative for reducing bacterial load in pockets.Studies have shown a significant reduction in probing depth (PD) when PDT was employed as an adjunct to SRP. However, there is dearth of studies in literature that have compared the photosensitizers, methylene blue and malachite green when used as dyes in PDT. Hence, this study is being undertaken to compare the efficacy of 1% methylene blue and 1% malachite green in improving clinical parameters when used as a component of PDT in chronic periodontitis patients.

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
Participant and Outcome Assessor Blinded

Eligibility Criteria

Ages
30.00 Year(s) to 65.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •A minimum of one tooth each in two contralateral quadrants having at least one site with a probing depth of ≥ 5mm and ≤ 7mm.
  • •Systemically healthy patients.
  • •Not received any antibiotics in the past 6 months.
  • •Plaque and Gingival index score of less than 1.

Exclusion Criteria

  • •Pregnant and lactating women.
  • •Allergic to malachite green or methylene blue.
  • •Active periodontal treatment within the last 6 months.

Outcomes

Primary Outcomes

Changes in probing depth(PD) and clinical attachment level(CAL) will be observed in the experimental sites.

Time Frame: baseline, 3 months, 6 months

Secondary Outcomes

  • Changes in plaque index scores, gingival index scores and bleeding index scores will be documented(At the baseline visit, 3 months and 6 months)

Investigators

Sponsor
Alina Pauly
Sponsor Class
Other [self]

Study Sites (1)

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