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Clinical Trials/CTRI/2024/06/068819
CTRI/2024/06/068819Not yet recruitingPhase 3

Antibacterial efficacy of combined zinc nanoparticles-calcium hydroxide root canal medication in healthy and diabetic patients with apical periodontitis - A case-control study

Shaima Misbah Shafiq1 site in 1 country60 target enrollmentStarted: June 30, 2024Last updated:
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Trial Snapshot

Phase
Phase 3
Status
Not yet recruiting
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
Analyze and quantify the antimicrobial effect of combined ZnO NP-Ca(OH)2 against common endodontic bacteria found in diabetic and healthy patients with pulp necrosis and/or apical periodontitis, by estimating the CFU of canal biofilm.
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

Population (P)-  Diabetic and healthy patients between the ages of 18 and 60 years, with apical periodontitis

Intervention (I)-  Placement of prepared intracanal medicament (combined ZnO NP-Ca (OH)2 paste)

Comparator (C)- Placement of standard intracanal medicament (Ca (OH)2 paste)

Outcomes (O)- Reduction in the CFU of endodontic bacteria by addition of ZnO NPs to Ca(OH)2  providing a novel medicament for enhanced root canal disinfection

Study Design

Study Type
Interventional
Allocation
Na
Masking
None

Eligibility Criteria

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

Inclusion Criteria

  • •Patients with controlled type 2 diabetes (HbA1c level is 6.5% or below)having non-vital teeth with apical periodontitis Radiographic evidence of apical periodontitis (PAI score: 2-5).

Exclusion Criteria

  • •Systemic factors such as pregnancy, and other co-existing immunocompromised conditions that can impair healing.
  • •Previously endodontically treated teeth Teeth with gross carious lesions (unrestorable), root fractures, open apex, intraoral and extraoral swelling, and extraoral sinus opening.
  • •Cases showing periodontal pockets deeper than 4 mm. Patients on antibiotic medications within 3 previous months.

Outcomes

Primary Outcomes

Analyze and quantify the antimicrobial effect of combined ZnO NP-Ca(OH)2 against common endodontic bacteria found in diabetic and healthy patients with pulp necrosis and/or apical periodontitis, by estimating the CFU of canal biofilm.

Time Frame: 6 months

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Shaima Misbah Shafiq
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

shaima misbah shafiq

JSS Dental College And Hospital

Study Sites (1)

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