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

Pain, Postoperative Clinical Trial

Official title:

Clinical and Radiographic Evaluation of Zinc Oxide-Propolis Mixture Versus Modified Triple Antibiotic Paste in Lesion Sterilization and Tissue Repair (LSTR) for the Treatment of Necrotic Primary Molars: A Randomized Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06158451
• Other study ID #: 208877371
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: January 31, 2025

Study information

• Verified date: February 2024
• Source: Cairo University
• Contact: Sara Kh Adam, Master
• Phone: 01221709929
• Email: sara.khaled[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: January 31, 2025
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 7 Years

Eligibility

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)

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:

1. Non restorable carious primary molars.

2. Grade III mobility

Related Conditions & MeSH terms

• Pain, Postoperative
• Periapical; Infection

Intervention

Combination Product:
• Zinc oxide propolis
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.
• Modified triple antibiotic paste
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain	Binary outcome measured with direct questioning to the patient	1 year
Primary	Tenderness to percussion	(binary outcome measured by percussion test using back of the dental mirror	1 year
Primary	Swelling / sinus tract	binary outcome measured with visual examination of the patient examination of the patient	1 year
Primary	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	Radiographic success	The amount of furcation / periapical radiolucency in comparison to preoperative remained static or decreased	6 months