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

NCT06625645 | Not Yet Recruiting

• 2 other identifiers: 14422023573623main investigator
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief Summary

Comparing between different intracanal medications with different combination forms of Modified Triple Antibiotic Paste, Calcium Hydroxide and Chlorehexidine, regarding antimicrobial efficacy through bacterial reduction count of enterococcus Faecalis and regarding clinical and radiographic success in non vital primary teeth necessitating pulpectomy with follow up time 1 year.

Conditions

Apical Periodontitis; Necrotic Primary Molars; Periapical Pathosis of Primary Molars

Keywords

Necrotic Primary Teeth; Apical Periodontitis; Non Vital primary teeth; periapical pathosis of primary teeth; intracanal medication; triple antibiotic paste; enterococcus faecalis; Microbiology; bacterial 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

Other Outcomes (1)

• Radiographic success

  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 chlorehexidine; Combination Product: Modified Triple Antibiotic Paste mixed with saline; Combination Product: Calcium Hydroxide mixed with chlorohexidine Intracanal medication

Interventions

Modified triple antibiotic paste (TAP) mixed with chlorehexidine COMBINATION_PRODUCT

M-TAP with CHX 2%

different types and combinations of intracanal medications for necrotic primary molars

Modified Triple Antibiotic Paste mixed with saline COMBINATION_PRODUCT

M-TAP mixed with saline

different types and combinations of intracanal medications for necrotic primary molars

Calcium Hydroxide mixed with chlorohexidine Intracanal medication COMBINATION_PRODUCT

calcium hydroxide powder mixed with CHX 2% solution as intracanal medication

different types and combinations of intracanal medications for necrotic primary molars

calcium hydroxide mixed with saline as intracanal medication COMBINATION_PRODUCT

calcium hydroxide mixed with saline as intracanal medication for necrotic primary molars

Calcium Hydroxide mixed with saline as control intracanal medication

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (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.
• Negative response to hot or cold pulp tester (ethyl chloride spray ).
• Decayed tooth with spontaneous unprovoked long dull aching pain showing signs of necrosis of the pulp

You may not qualify if:

• Medically compromised and uncooperative children
• Tooth indicated for extraction
• Mobile teeth (Miller's Grade 2 or more)
• teeth with more than two-thirds of root resorption
• previous endodontic treatment

Sponsors & Collaborators

• Mahy Abdel Raouf Aly Kamar: lead

MeSH Terms

Conditions

Periapical Periodontitis

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium 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
• Primary Completion: May 1, 2025
• Study Completion: January 1, 2026
• Last Updated: October 17, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share