Actively Recruiting
Zinc Oxide Ozonated Oil Versus Modified Triple Antibiotic Paste as a Lesion Sterilization and Tissue Repair Technique in Primary Molars
Led by Tanta University · Updated on 2025-03-03
30
Participants Needed
2
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The trial investigates the clinical and radiographic effects of zinc oxide-ozonated olive oil compared with Modified Triple Antibiotic Paste (MTAP) as a Lesion Sterilization and Tissue Repair (LSTR) technique in primary molars. This study focuses on children aged 4 to 7 years with primary molars affected by pulp necrosis or chronic pulp infection. The aim is to find a simpler and faster alternative to traditional pulpectomy treatments while preserving primary teeth essential for proper dental development. Participants will receive either zinc oxide-ozonated olive oil or Modified Triple Antibiotic Paste applied using the LSTR technique to disinfect and repair non-vital primary molars. The study uses a randomized design with single masking and includes two experimental arms comparing these treatments. Both treatments aim to sterilize the infected root canal system and support tissue repair without extensive instrumentation. During the study, participants will be monitored at 3, 6, 9, and 12 months for clinical and radiographic outcomes. Researchers will assess pain, infection signs, tooth mobility, and radiographic features such as periodontal ligament space widening and root involvement. The follow-up will help evaluate the success of treatments in preserving the teeth and preventing complications. Total participation duration extends through the 12-month follow-up period.
CONDITIONS
Brief Title
Zinc Oxide Ozonated Olive Oil in LSTR
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Cooperative patients aged 4 to 7 years with no systemic illness
- Bilateral mandibular primary molars with signs or symptoms of pulp necrosis or chronic infection
- Presence of spontaneous pain or tenderness to percussion
- Presence of chronic apical abscess, sinus tract, or grade I mobility
- Teeth must be restorable
- Radiographic signs including widening of periodontal ligament space, radicular involvement, and furcation involvement less than or equal to half of the shortest root length
You will not qualify if you...
- Physiologic root resorption exceeding one-third of root length
- Excessive internal resorption
- Non-restorable teeth with greater than grade I mobility
- Perforation into the bifurcation
- Presence of any underlying pathological lesion
- Previous allergy to the antibiotics used in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Participants aged 4 to 7 years with specific dental conditions are evaluated for eligibility including medical history and dental examination.
Duration - Single treatment session with follow-up assessments over 12 months
Participants receive lesion sterilization and tissue repair treatment using either Zinc Oxide Ozonated Oil or Modified Triple Antibiotic Paste in primary molars with pulp necrosis or chronic infection.
Initial treatment visit followed by follow-up visits at 3, 6, 9, and 12 months
Duration - 12 months
Participants are monitored for clinical and radiographic outcomes after treatment to assess effectiveness and safety over 12 months.
Follow-up visits at 3, 6, 9, and 12 months post-treatment
Trial Site Locations
Total: 2 locations
1
Faculty of dentistry Tanta university
Tanta, Gharbia Governorate, Egypt, +20
Actively Recruiting
2
Nouran Esmail Mohamed Shalaby
Menouf, Egypt, +20
Actively Recruiting
Research Team
N
nouran esmail shalaby, master
.
.ahmad al el kholy, master
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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