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Clinical Trials/CTRI/2024/06/068605
CTRI/2024/06/068605Not yet recruitingNot Applicable

Comparative evaluation of the effect of Blue M active oxygen gel and coe-pack dressing on postoperative surgical depigmentation healing-A Clinical Study

DR TUSHARIKA SHARMA1 site in 1 country34 target enrollmentStarted: June 16, 2024Last updated:
Conditions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
34
Locations
1
Primary Endpoint
Dummett gupta oral pigmentation index

Study Overview

Brief Summary

Topical anesthesia was applied with 2% lidocaine, and the entire pigmented layer of gingival epithelium in addition to an underlying layer of connective tissue was removed by abrasion with a no. 15 surgical blade. The depigmentation procedure was performed from the mucogingival junction to the base of the interdental papilla. Direct pressure was applied with a sterile gauze to control hemorrhage during the surgical procedure .The depigmented

area was covered with the conventional Coe-Pak periodontal dressing in the control group, whereas the Blue M active oxygen gel was applied to cover the depigmented area in the test group. Patient will be asked to apply Blue M active oxygen gel three times per day for one week at home. Patients will be recalled for follow up visit after 24 hours and 1 week postoperatively for the removal of Coe-pak dressing.

Study Design

Study Type
Interventional
Allocation
Other
Masking
Outcome Assessor Blinded

Eligibility Criteria

Ages
20.00 Year(s) to 38.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •Patients with gingival hyperpigmentation Patient with scoring criteria for Dummet Oral Pigmentation index more than 1.

Exclusion Criteria

  • •Smokers Pregnant and lactating women Medically compromised patients Those with a history of periodontal surgery in less than three months Those with gingival pigmentation associated with other syndromes and lesions Those with a score of more than one for plaque and gingivitis indices Those with a score of less than three for DOP index.

Outcomes

Primary Outcomes

Dummett gupta oral pigmentation index

Time Frame: baseline , 1week , 2 weeks , 3 weeks and 1 month

Secondary Outcomes

  • Visual Analog Scale, VAS (Steigmann 1965)(after 2 hrs , after 24 hrs , 2 days , 3 days and 7 days)
  • Re-epithelization index study Sridharan and Shankar, 2012(baseline , 1week , 2 weeks , 3 weeks and 1 month)

Investigators

Sponsor
DR TUSHARIKA SHARMA
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Dr Tusharika Sharma

KM SHAH DENTAL COLLEGE AND HOSPITAL

Study Sites (1)

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