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

Not Applicable

Not yet recruiting

• Conditions: Periapical; Infection; Pain, Postoperative
• Interventions: Combination Product: Zinc oxide propolis; Combination Product: Modified triple antibiotic paste

• Registration Number: NCT06158451
• Lead Sponsor: Cairo University

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.

Detailed Description

The promising results of propolis as a natural antibiotic in previous in- vivo studies made it interesting to combine propolis to the golden standard zinc oxide eugenol as an intracanal medication in pulp affected primary molars and use this mix as a natural substitute to the modified triple antibiotic paste (m-TAP) and therefore overcoming the antibiotic bacterial resistance, allergy and developmental anomalies that might arise in permanent successor teeth from m-TAP usage.

Study Timeline

• Study First Submitted: 2023-11-28
• Study First Submitted QC: 2023-11-28
• Study First Posted: 2023-12-06
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-05
• Last Update Posted: 2024-02-07
• Study Start: 2024-03-01
• Primary Completion: 2024-08-30
• Study Completion: 2025-01-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Children:

  1. Cooperative children aged 4 -7 years old.
  2. Systemically healthy.

• Teeth:

Clinical criteria:

1. Necrotic primary mandibular second molar teeth.
2. Spontaneous pain or tenderness to percussion
3. Deep carious lesion with pulp exposure.
4. Presence of chronic apical abscess or sinus tract Tooth should be restorable. (Thakur et al., 2021)

Radiographic criteria:

1. Coronal-radiographic evidence of a deep carious lesions or lesion approximating pulp
2. Radicular discontinuity of lamina dura, furcation involvement less than or equal to half of shortest root in vertical dimension. (Thakur et al., 2021)

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Exclusion Criteria

• Children:

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Zinc-oxide Propolis (Zno-P)	Zinc oxide propolis	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.
Modified triple antibiotic paste	Modified triple antibiotic paste	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.

Primary Outcome Measures

Name	Time	Method
Tenderness to percussion	1 year	(binary outcome measured by percussion test using back of the dental mirror
Postoperative pain	1 year	Binary outcome measured with direct questioning to the patient
Swelling / sinus tract	1 year	binary outcome measured with visual examination of the patient examination of the patient
Mobility	1 year	(measured by mobility test) and according to Miller's Grades; reduction in grade of mobility from preoperative baseline was treated as success

Secondary Outcome Measures

Name	Time	Method
Radiographic success	6 months	The amount of furcation / periapical radiolucency in comparison to preoperative remained static or decreased