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

NCT ID: NCT06158451

Last Updated: 2024-02-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2025-01-31

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.

Conditions

Pain, Postoperative; Periapical; Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Zinc-oxide Propolis (Zno-P)

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.

Group Type: EXPERIMENTAL

Zinc oxide propolis

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Modified triple antibiotic paste

Intervention Type: 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

Interventions

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.

Intervention Type: COMBINATION_PRODUCT

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

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

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:

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1. Non restorable carious primary molars.

2. Grade III mobility

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Sara Khaled Adam

Assistant lecturer pediatric dentistry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sherine Badr, Professor

Role: STUDY_DIRECTOR

Cairo University

Central Contacts

Sara Kh Adam, Master

Role: CONTACT

sara.khaled@dentistry.cu.edu.eg

01221709929

Other Identifiers

208877371

Identifier Type: -

Identifier Source: org_study_id