Clinical and Radiographic Evaluation of Zinc Oxide-Propolis Mixture Versus Modified Triple Antibiotic Paste in LSTR

NCT06158451 | Not Yet Recruiting

• 1 other identifier: 208877371
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this study is to evaluate and compare the clinical effectiveness of zinc oxide-propolis mixture with triple antibiotic paste in LSTR as root canal filling material in necrotic primary molars.

Conditions

Pain, Postoperative; Periapical; Infection

Keywords

propolis; modified triple antibiotic paste; lesion sterilization and tissue repair

Outcome Measures

Primary Outcomes (4)

• Postoperative pain

  Binary outcome measured with direct questioning to the patient

  1 year

• Tenderness to percussion

  (binary outcome measured by percussion test using back of the dental mirror

  1 year

• Swelling / sinus tract

  binary outcome measured with visual examination of the patient examination of the patient

  1 year

• Mobility

  (measured by mobility test) and according to Miller's Grades; reduction in grade of mobility from preoperative baseline was treated as success

  1 year

Secondary Outcomes (1)

• Radiographic success

  6 months

Study Arms (2)

Zinc-oxide Propolis (Zno-P)

EXPERIMENTAL

Propolis liquid (Brazilian Green Bee Propolis Liquid Extract, Uniflora®) and Zinc oxide powder will be mixed and added after minimal instrumentation until size 20 to remove all the accessible necrotic pulp and placed on the pulpal floor and intracanal.

Combination Product: Zinc oxide propolis

Modified triple antibiotic paste

ACTIVE COMPARATOR

Metronidazole tablets 500 mg (Flagyl®, Sanofi, Egypt), ciprofloxacin tablets 500 mg (Ciprofloxacin tablets USP 39®, European pharmaceuticals, Egypt,), and clindamycin capsules 300 mg(Dalacin C™ Pfizer, Egypt) will be mixed and added after minimal instrumentation until size 20 to remove all the accessible necrotic pulp and placed on the pulpal floor and intracanal.

Combination Product: Modified triple antibiotic paste

Interventions

Zinc oxide propolis COMBINATION_PRODUCT

Propolis liquid (Brazilian Green Bee Propolis Liquid Extract, Uniflora®) and Zinc oxide powder will be mixed on a glass slab with the help of a stainless -steel spatula. • The mixing ratio of zinc oxide powder and Propolis liquid is 2:1 until a paste like consistency is reached.

Zinc-oxide Propolis (Zno-P)

Modified triple antibiotic paste COMBINATION_PRODUCT

Chemotherapeutic agents used are metronidazole tablets 500 mg (Flagyl®, Sanofi, Egypt), ciprofloxacin tablets 500 mg (Ciprofloxacin tablets USP 39®, European pharmaceuticals, Egypt,), and clindamycin capsules 300 mg(Dalacin C™ Pfizer, Egypt). * After the removal of enteric coating of tablets with the help of blade, the drugs are pulverized into fine powder using sterilized mortar and pestle. * The same amount of each powdered drug (1:1:1) is mixed to form m-TAP powder which is mixed with one part of propylene glycol (P) and the same volume of macrogol (M) to form a paste like consistency

Modified triple antibiotic paste

Eligibility Criteria

• Age: 4 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children:
• Cooperative children aged 4 -7 years old.
• Systemically healthy.
• Teeth:
• Clinical criteria:
• Necrotic primary mandibular second molar teeth.
• Spontaneous pain or tenderness to percussion
• Deep carious lesion with pulp exposure.
• Presence of chronic apical abscess or sinus tract Tooth should be restorable. (Thakur et al., 2021)
• Radiographic criteria:
• Coronal-radiographic evidence of a deep carious lesions or lesion approximating pulp
• Radicular discontinuity of lamina dura, furcation involvement less than or equal to half of shortest root in vertical dimension. (Thakur et al., 2021)

You may not qualify if:

• Children:
• With physical or emotional alteration.
• Children with systemic disease.
• Previous history of allergy to antibiotics used in the study.
• Children that will not attend follow up. • Teeth:
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• Non restorable carious primary molars.
• Grade III mobility

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Pain, Postoperative; Infections

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Sherine Badr, Professor

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

Sara Kh Adam, Master

CONTACT

01221709929; sara.khaled@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer pediatric dentistry

Study Record Dates

• First Submitted: November 28, 2023
• First Posted: December 6, 2023
• Study Start: March 1, 2024
• Primary Completion: August 30, 2024
• Study Completion: January 31, 2025
• Last Updated: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share