Trials Sponsors Conditions Drugs Pricing

Conditions

Apical Periodontitis Necrotic Primary Molars Periapical Pathosis of Primary Molars

Keywords

Necrotic Primary TeethApical PeriodontitisNon Vital primary teethperiapical pathosis of primary teethintracanal medicationtriple antibiotic pasteenterococcus faecalisMicrobiologybacterial reduction

Outcome Measures

Primary Outcomes (1)

Enterococcus faecalis bacterial reduction
Samples from canal using paper point size 20 with pumping action from the widest canal three times one after the access and gaining patency, second one after chemomechanical preparation and the third one after 7 days from intracanal medication insertion in the canal, then the samples will be placed in sterile vials with thioglycolate (transport medium). The vials will be sealed tightly to avoid contamination and labeled. The labeled vials will be kept in a freezer and will be sent to the laboratory within 1 hour of collection, and samples will be assessed for total E. faecalis count.
3 times, one after the access and gaining patency, second one after chemomechanical preparation and the third one after 7 days from intracanal medication insertion in the canal

Secondary Outcomes (1)

Clinical success
3,6 and 12 months

Study Arms (2)

Calcium Hydroxide mixed with saline as control intracanal medication

ACTIVE COMPARATOR

using calcium hydroxide with saline as control intracanal medication for necrotic primary molars

Combination Product: calcium hydroxide mixed with saline as intracanal medication

different types and combinations of intracanal medications for necrotic primary molars

EXPERIMENTAL

Combination Product: Modified triple antibiotic paste (TAP) mixed with chlorehexidineCombination Product: Modified Triple Antibiotic Paste mixed with salineCombination Product: Calcium Hydroxide mixed with chlorohexidine Intracanal medication

Interventions

Modified triple antibiotic paste (TAP) mixed with chlorehexidineCombination product

M-TAP with CHX 2%

different types and combinations of intracanal medications for necrotic primary molars

Modified Triple Antibiotic Paste mixed with salineCombination product

M-TAP mixed with saline

different types and combinations of intracanal medications for necrotic primary molars

Eligibility Criteria

Age4 Years - 8 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

Primary molars necessitating pulpectomy diagnosed with deep dental caries with pulp necrosis, apical periodontitis and periapical pathosis or both.
Non-Vital pulps.

Sponsors & Collaborators

Mahy Abdel Raouf Aly Kamar
Otherlead

MeSH Terms

Conditions

Periapical Periodontitis

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Periapical DiseasesJaw DiseasesStomatognathic DiseasesPeriodontal DiseasesMouth DiseasesPeriodontitis

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Central Study Contacts

Mahy kamar Mahy A.Raouf Kamar, Assistant Lecturer

CONTACT

01550831173 Mahy_kamar@dentistry.cu.edu.eg

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR INVESTIGATOR
PI Title: Principle investigator

Study Record Dates

First Submitted

September 28, 2024

First Posted

October 3, 2024

Study Start

January 1, 2025

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

Comparative Evaluation of Antimicrobial Efficacy, Clinical and Radiographic Success of Calcium Hydroxide, Chlorhexidine, and Modified Triple Antibiotic Paste in Different Combination Forms As Intracanal Medicaments Against Enterococcus Faecalis in Primary Teeth

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Calcium Hydroxide mixed with saline as control intracanal medication

different types and combinations of intracanal medications for necrotic primary molars

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

Other Outcomes (1)

You may not qualify if:

Data Sharing

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Calcium Hydroxide mixed with saline as control intracanal medication

different types and combinations of intracanal medications for necrotic primary molars

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

Other Outcomes (1)

You may not qualify if:

Data Sharing

Source record