Zinc Oxide Ozonated Olive Oil in LSTR

NCT06854744 | Recruiting

• 1 other identifier: 10-23-2093
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

This study will be carried out to evaluate and compare the clinical and radiographic effect of zinc oxide-ozonated olive oil (ZnO-OO) versus Modified Triple Antibiotic Paste (MTAP) as a Lesion Sterilization and Tissue Repair Technique in Primary Molars

Conditions

Pulpitis - Irreversible; Ozone; Pulp Disease, Dental; Primary Teeth

Keywords

ZnOO /MTAP

Outcome Measures

Primary Outcomes (2)

• primary out come

  .evaluate clinical outcomes including Absence of pain or tenderness, No tooth mobility, and Presence of healthy soft tissue; no swelling, redness, or sinus tract for both groups including zinc oxide ozonated oil group and MTAP group during the follow-up periods 3,6,9,12 months follow up evaluate radiographic effect of both materials on: Continuity of lamina Dura, Static or reduction in the size of existing pathologic intra-radicular or periapical radiolucency., No newly formed radiographic lesion, Absence of pathological root resorption, and Evidence of bone regeneration utilizing gray value

  3,6,9,12 months

• primary outcome

  evaluate radiograhic effect of both materials on : * Continuity of lamina Dura. * Static or reduction in the size of existing pathologic intra-radicular or periapical radiolucency. * No newly formed radiographic lesion. * Absence of pathological root resorption * Evidence of bone regeneration utilizatig gray value

  3,6,9,12 months follow up

Secondary Outcomes (1)

• secondary out come

  12 months follow up

Study Arms (2)

Zinc Oxide Ozonated Oil

EXPERIMENTAL

Zinc Oxide Ozonated Oil as a Lesion Sterilization and Tissue Repair Technique in Primary Molars

Procedure: lesion sterlization and tissue repair; Other: Zinc Oxide Ozonated Oil

Modified Triple Antibiotic Paste

EXPERIMENTAL

Modified Triple Antibiotic Paste (MTAP)as a Lesion Sterilization and Tissue Repair Technique in Primary Molars

Procedure: lesion sterlization and tissue repair; Other: Modified Triple Antibiotic Paste

Interventions

lesion sterlization and tissue repair PROCEDURE

evaluate and compare the clinical and radiographic effect of zinc oxide-ozonated olive oil (ZnO-OO) versus Modified Triple Antibiotic Paste (MTAP) as a Lesion Sterilization and Tissue Repair Technique in Primary Molars.

Also known as: zinc oxide ozonated oil and modified triple antibiotic paste

Modified Triple Antibiotic Paste; Zinc Oxide Ozonated Oil

Zinc Oxide Ozonated Oil OTHER

Zinc Oxide Ozonated Oil

Zinc Oxide Ozonated Oil

Modified Triple Antibiotic Paste OTHER

Modified Triple Antibiotic Paste

Modified Triple Antibiotic Paste

Eligibility Criteria

• Age: 4 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Bilateral mandibular primary molars showing signs and symptoms of pulp necrosis or chronic pulp infection with/without hemorrhage, suppuration, or purulence.
• Spontaneous pain or tenderness to percussion. 4- Presence of chronic apical abscess, sinus tract, or grade I mobility. 5-The tooth should be restorable. 6- Radiographic characteristics are:
• Widening of Periodontal ligament space.
• Radicular involvement.
• Furcation involvement less than or equal to half of the shortest root in the vertical dimension

You may not qualify if:

• Physiologic root resorption is more than one-third of its length.
• Excessive internal resorption.
• Non-restorable teeth exhibiting greater than grade I mobility.
• Perforation into the bifurcation.
• Any underlying pathological lesion.
• Any previous history of allergy to the antibiotics used in the study. -

Sponsors & Collaborators

• Tanta University: lead

Study Sites (2)

Faculty of dentistry Tanta university

Tanta, Gharbia Governorate, +20, Egypt

RECRUITING

Nouran Esmail Mohamed Shalaby

Menouf, +20, Egypt

RECRUITING

MeSH Terms

Conditions

Dental Pulp Diseases

Interventions

Wound Healing

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Regeneration; Biological Phenomena

Study Officials

• Shaimaa Sh El-Desokey, Professor

  Faculty of dentistry Tanta university , tanta

  PRINCIPAL INVESTIGATOR

• Fatma el hendawy, Professor

  Faculty of dentistry Tanta university , Tanta

  STUDY DIRECTOR

• Nancy metwally, doctor

  Faculty of dentistry Tanta university , Tanta

  STUDY DIRECTOR

Central Study Contacts

nouran esmail shalaby, master

CONTACT

+20 01018710314; PG_167682@dent.tanta.edu.eg

.ahmad al el kholy, master

CONTACT

+20 0109552575; PG_167682@dent.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Group I: Zinc Oxide Ozonated Olive- oil will be applied to the pulp stamps of the molars on one side. Group II: MTAP will be applied to the pulp stamps of the molars on the other side.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Zinc Oxide Ozonated Oil Versus Modified Triple Antibiotic Paste as a Lesion Sterilization and Tissue Repair Technique in Primary Molars

Model Details: This study will be carried out to evaluate and compare the clinical and radiographic effect of zinc oxide-ozonated olive oil (ZnO-OO) versus Modified Triple Antibiotic Paste (MTAP) as a Lesion Sterilization and Tissue Repair Technique in Primary Molars

Study Record Dates

• First Submitted: February 18, 2025
• First Posted: March 3, 2025
• Study Start: January 15, 2024
• Primary Completion: February 1, 2025
• Study Completion: April 1, 2025
• Last Updated: March 3, 2025

Record last verified: 2025-02

Locations

EG (2)