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Clinical Trials/CTRI/2019/09/021156
CTRI/2019/09/021156Not yet recruitingPhase 2

“Clinical assessment of Open flap debridement using magnifying loupes and surgical operating microscope –A split mouth comparative studyâ€

Vishnu dental college1 site in 1 country20 target enrollmentStarted: October 9, 2019Last updated:
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Conditions

Trial Snapshot

Phase
Phase 2
Status
Not yet recruiting
Enrollment
20
Locations
1
Primary Endpoint
2.Early Wound healing index (EHI).
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

A randomized parallel clinical trial was planned to be done to evaluate the efficacy of magnification during periodontal therapy including the ergonomic benefits of clinician .

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
Not Applicable

Eligibility Criteria

Ages
30.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •1.Patients having moderate to severe periodontitis.
  • •2.Systemically healthy patients 3.Persistence of probing pocket depth ≥ 5mm in at least 3 teeth in more than one sextant after Phase I therapy.

Exclusion Criteria

  • •1.Patients who are known diabetics.
  • •2.Pregnant patients.
  • •3.History of any periodontal surgery done prior to the treatment.

Outcomes

Primary Outcomes

2.Early Wound healing index (EHI).

Time Frame: 1.bleeding index after 3 months and 6 months | 2.Early wound healing index after 1 week

3.Probing pocket depth (PPD).

Time Frame: 1.bleeding index after 3 months and 6 months | 2.Early wound healing index after 1 week

4.Clinical attachment level (CAL).

Time Frame: 1.bleeding index after 3 months and 6 months | 2.Early wound healing index after 1 week

1.Bleeding index (BI).

Time Frame: 1.bleeding index after 3 months and 6 months | 2.Early wound healing index after 1 week

Secondary Outcomes

  • Ergonomic benefit to the clinician.(18/7/2020)

Investigators

Sponsor Class
Other []

Study Sites (1)

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