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Clinical Trials/CTRI/2025/07/091890
CTRI/2025/07/091890Not yet recruitingPhase 3

Evaluation Of Effect Of Syzygium Cumini & Orange Peel Mouthwash On Periodontal Health In Patients Undergoing Orthodontic Treatment- A Randomized Controlled Trial.

self1 site in 1 country60 target enrollmentStarted: December 24, 2025Last updated:

Trial Snapshot

Phase
Phase 3
Status
Not yet recruiting
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
plaue index, gingival index

Study Overview

Brief Summary

Orthodontic treatment plays a crucial role in aligning teeth and improving both function and aesthetics. However, it can also pose challenges to periodontal health. Common periodontal complications associated with orthodontic therapy include gingivitis, periodontitis, gingival recession or hypertrophy, alveolar bone loss, dehiscence, fenestration, interdental folds, and the formation of dark triangles. The primary factor contributing to these issues is plaque accumulation, which plays a key role in the initiation, progression, and recurrence of periodontal disease, particularly in patients with a compromised periodontium. The presence of orthodontic brackets and elastics can hinder effective plaque removal, increasing the risk of gingivitis. Additionally, orthodontic treatment alters the balance of oral microflora by promoting bacterial retention, further exacerbating periodontal concerns.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant and Outcome Assessor Blinded

Eligibility Criteria

Ages
35.00 Year(s) to 45.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • undergoing orthodontic treatment and having PPD and CAL of more than 4 mm.

Exclusion Criteria

  • Patients who have undergone any periodontal therapy in the past 6 months.
  • Patients with systemic diseases.
  • History of any medication including antibiotic treatment within the previous 3 months or regular use of specific drugs known to affect periodontal tissues.
  • Pregnant women and lactating mothers.

Outcomes

Primary Outcomes

plaue index, gingival index

Time Frame: BASELINE, 1 MONTH, 3 MONTHS

Secondary Outcomes

  • PBI,PPD,CAL(BASELINE,1 MONTH, 3 MONTHS)

Investigators

Sponsor
self
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

DR SUREKHA RATHOD

Rnajeet Deshmukh Dental College, Nagpur

Study Sites (1)

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