Clinical trial
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
Name
208877371
Description
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.
Trial arms
Trial start
2024-03-01
Estimated PCD
2024-08-30
Trial end
2025-01-31
Status
Not yet recruiting
Treatment
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.
Arms:
Zinc-oxide Propolis (Zno-P)
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
Arms:
Modified triple antibiotic paste
Size
40
Primary endpoint
Postoperative pain
1 year
Tenderness to percussion
1 year
Swelling / sinus tract
1 year
Mobility
1 year
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'Double', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}
Updated at
2024-02-07
1 organization
2 products
3 indications
Organization
Cairo UniversityProduct
Zinc oxide propolisIndication
PainIndication
PostoperativeIndication
Periapical infection