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Clinical Trials/CTRI/2025/10/095678
CTRI/2025/10/095678
Not yet recruiting
Not Applicable

Evaluation of effect of Syzygium cumini and orange peel Mouthwash on Periodontal Health in Type 2 Diabetes Mellitus Patients A Randomized Controlled Trial

Dr Surekha Rathod1 site in 1 country60 target enrollmentStarted: April 8, 2026Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Dr Surekha Rathod
Enrollment
60
Locations
1
Primary Endpoint
Gingival Index (GI)

Overview

Brief Summary

While single-herb-based mouthwashes are available on the market, there is a lack of literature on polyherbal mouthwashes for the treatment of periodontitis in diabetic patients. So the aim of the study is to evaluate  the  effect of orange peel and s. cumuni seed extract containing  Mouthwash on Periodontal Health in Type 2 Diabetes Mellitus Patients.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant, Investigator and Outcome Assessor Blinded

Eligibility Criteria

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

Inclusion Criteria

  • Patients who have undergone any periodontal therapy in the past 6 months.
  • Patients with systemic diseases other than diabetes.
  • 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.

Exclusion Criteria

  • Patients who have undergone any periodontal therapy in the past 6 months.
  • Patients with systemic diseases other than diabetes.
  • 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

Gingival Index (GI)

Time Frame: baseline 1,3 months

Papillary Bleeding Index (PBI)

Time Frame: baseline 1,3 months

Probing Pocket Depth (PPD)

Time Frame: baseline 1,3 months

Clinical Attachment Level (CAL)

Time Frame: baseline 1,3 months

Plaque Index (PI)

Time Frame: baseline 1,3 months

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Dr Surekha Rathod
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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