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

Cairo University (CU)

Status: Not yet enrolling

Conditions: Periapical; Infection; Pain, Postoperative

Treatments: Combination Product: Modified triple antibiotic paste; Combination Product: Zinc oxide propolis

Study type: Interventional

Funder types: Other

Identifiers

NCT06158451

208877371

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 4 to 7 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Zinc-oxide Propolis (Zno-P)

Experimental group

Description:

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.

Treatment:

Combination Product: Zinc oxide propolis

Modified triple antibiotic paste

Active Comparator group

Description:

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.

Treatment:

Combination Product: Modified triple antibiotic paste