ClinicalTrials.gg
RecruitingNCT06854744Zn-OO/MTAPUpdated Mar 3, 2025

Zinc Oxide Ozonated Olive Oil in LSTR

An interventional study of lesion sterlization and tissue repair and Zinc Oxide Ozonated Oil in Pulpitis - Irreversible, Ozone and Pulp Disease, Dental, sponsored by Tanta University. Recruiting at 2 sites in Egypt. Open to participants aged 4 Years to 7 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-03.

Sponsored by Tanta University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Feb 2025, 1 year 9 months ago, but the record still lists the study as recruiting.
  • Registered 1 year 1 month after the study started (first participant enrolled Jan 2024, registered Feb 2025).
  • Started Jan 2024; still recruiting 2 years 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
4 Years to 7 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 33 studies in Dental Pulp Diseases with a site in Egypt — 10 open to participants now, 11 under way, 2 of them phase 3. Dental Pulp Diseases · Egypt.

Planned enrollment
22nd of 31
30 · median 45
Started
2024
with 4 others
No phase
22 of 33
7 open now
Primary completion
2025-02
later than 2 of 10 live
Registered
26th of 33
by date
Lead sponsor
4 of 33
Tanta University

Among the 33 studies in Dental Pulp Diseases with a site in Egypt, this one is the 22nd largest by planned enrollment of the 31 interventional ones that give a count, is one of 5 that started in 2024, is one of 22 with no phase, reaches primary completion later than 2 of the 10 other live ones, and was the 26th registered.

Dental Pulp Diseases

130 studies on the registry are indexed under Dental Pulp Diseases; 37 are open to participants now.

Browse Dental Pulp Diseases studies →

Open to participants now

10 of the 33 studies in Dental Pulp Diseases with a site in Egypt are open now. Recruiting first, the newest first:

4 more — sign in →

All 10 open studies →

A study can be open while its sites in Egypt have not opened yet or have stopped. Only those recruiting at a site in Egypt →

Who these studies take

Of the 16 Dental Pulp Diseases studies recruiting now, 5 (31%) set no upper age limit and 10 (63%) stop at 75 or younger; 5 take children under 18; 12 take healthy volunteers.

This study: 4 Years to 7 Years · all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 33 studies in Dental Pulp Diseases with a site in Egypt, or all of them as a file.
02

Study 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

Read the detailed description

Preservation of primary dentition is crucial for the development of arch form, esthetics, function, mastication, and normal eruption of permanent teeth. Premature loss, especially of the primary second molar, can cause several problems. The first permanent molars typically erupt mesially as a result, leading to some problems including the ectopic eruption of the second premolar, the loss of space for the succeeding permanent teeth and functional impairment 1.

Dental caries is the most prevalent non-communicable disease in children with significant aesthetic, functional, and quality of life deterioration2. Caries lesions can jeopardize the teeth' vitality, as their progression cause infection, pain, and even early tooth loss 2,3. Thus, timely intervention is key to avoid unfavorable repercussions for the child. Depending on the depth of caries (which may have pulp involvement), two approaches may be considered in the primary dentition: vital pulp therapy (VPT) or non-vital therapy (NPT)2,4.

When the pulp can be recovered, VPT may be an option and three options are available: indirect pulp treatment (IPT), direct pulp cap (DPC), and pulpotomy 2-6.

When the caries lesion progresses to the point where the pulp necrotizes, then an NPT is performed, such as a pulpectomy 4. It is a nonvital treatment (NVT), a root canal treatment with irreversibly inflamed or necrotic pulp resulting from caries or trauma 2,4,6,7. Pulpectomy has been the gold-standard treatment for primary teeth with pulp necrosis or irreversible pulp inflammation and is based on the debridement of the root canals with manual or rotary instruments together with the use of antimicrobial irrigation solutions to decontaminate the root canal system for posterior filling with resorbable materials 8 However, the inherent characteristics of the root canal system in primary teeth make this procedure an endodontic challenge, especially in molars 9,10.

In the 1990s, an innovative procedure called lesion sterilization and tissue repair (LSTR) was proposed as an alternative biologic approach that was thought to facilitate the disinfection of dentinal carious lesions, pulp, and periapical lesions in primary teeth 11-13 with the advantages of being simpler and faster 14,15.

The LSTR is a minimally invasive endodontic therapy method that involves the introduction of an antibiotic combination in a propylene glycol vehicle to disinfect root canal systems and periapical lesions 16. It is also known as no instrumental endodontic treatment (NIET) 17. The rationale of LSTR is that combination of three antibiotics (3Mix) can sterilize necrotic pulps and infected root dentine of primary teeth. In primary dentition, LSTR has shown a high rate of clinical success as a substitute for pulpectomy 14,18.

A single antibiotic is insufficient to eradicate pathogenic flora; hence a combination of drugs popularly known as ''triple antibiotic paste'' (TAP) is recommended. This mix is potently active against a wide range of bacteria. It aids in disinfecting and sterilizing the root canal system. It also allows the entry and growth of new tissue in the radicular area in regenerative therapy in the case of young, immature teeth. TAP can also assist in the development of a discipline that will allow for the successful application of other desired and necessary therapies 19,20.

Most commonly, a combination of three broad-spectrum antibiotics, namely, ciprofloxacin, metronidazole and minocycline are used for root canal disinfection. Metronidazole acts against obligate anaerobes, which are the most commonly isolated species from infected root canals. Minocycline is a bacteriostatic long-acting antibiotic, potent against a wide range of microorganisms. Ciprofloxacin is added to eradicate Gram-negative species21,22.

The use of cefaclor (a second-generation cephalosporin) instead of minocycline and ornidazole instead of metronidazole in 3Mix improves clinical outcomes 23,24.

Cruz et al. 25 showed that the incorporation of propylene glycol and macrogol (MP) as a carrier vehicle dramatically raised the penetration of these drugs.

Herbal and natural extracts employed in dentistry as irrigants and intracanal medicaments have gained popularity in recent decades because of their antimicrobial activity, biocompatibility, and anti-inflammatory and anti-oxidant properties 26.

New generations of disinfecting agents have been developed among them is ozone, which is a powerful oxidizing agent and can be used to eliminate bacteria in root canals 27.

Ozone's antibacterial impact gets triggered by oxygenated radicals in aqueous solutions, this will cause changes in the osmotic permeability of the cell membranes resulting in cell damage 28. Ozone is not only an antimicrobial agent, but it can also enhance blood circulation and immune response. It can modulate the cellular and humoral immune system of the patient by the proliferation of immunocompetent cells and the synthesis of immunoglobulins. It can stimulate the phagocytosis process, activate the macrophages, and increase the sensitivity of microorganisms to macrophages29.

There are multiple forms for the application of ozone as ozone gas, ozonated water, and ozonated oil that are used for root canal irrigation and as intra-canal medicaments to obtain disinfection of root canal systems. Ozonated water and olive oil act by entrapping ozone and then emitting it 30.

Nowadays, ozone is utilized in the manufacturing of ozonated olive oil (Oleozon), which is increasingly being utilized as a clinical therapeutic agent for wound healing 31.

Olive oil has anti-inflammatory and antibacterial properties, mainly due to its fatty acid's oleic acid and linoleic acid, and its polyphenol compounds, such as hydroxytyrosol, tyrosol, oleuropein, and oleocanthal 32.

Up to our knowledge, no previous studies discussed Zinc oxide-ozonated olive oil as pulp capping material in non-vital primary molars.

Thus, the main purpose of this study is to evaluate and compare the clinical and radiographic effect of zinc oxide-ozonated olive oil versus Modified Triple Antibiotic Paste (MTAP) utilizing LSTR technique in the treatment of non-vital primary molars.

03

Conditions studied

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

Browse trials for

Keywords

  • ZnOO /MTAP
04

Who can participate

Ages eligible
4 Years to 7 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria: 1- Cooperative patients in the age group of (4-7) years with no associated systemic illness.

2- Bilateral mandibular primary molars showing signs and symptoms of pulp necrosis or chronic pulp infection with/without hemorrhage, suppuration, or purulence.

3- 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:

  1. Widening of Periodontal ligament space.
  2. Radicular involvement.
  3. Furcation involvement less than or equal to half of the shortest root in the vertical dimension

    -

    Exclusion Criteria: Exclusion criteria :

    1. Physiologic root resorption is more than one-third of its length.
    2. Excessive internal resorption.
    3. Non-restorable teeth exhibiting greater than grade I mobility.
    4. Perforation into the bifurcation.
    5. Any underlying pathological lesion.
    6. Any previous history of allergy to the antibiotics used in the study. -
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Zinc Oxide Ozonated Oil

    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

  • Experimental
    Modified Triple Antibiotic Paste

    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

  • Procedurelesion sterlization and tissue repair

    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

  • OtherZinc Oxide Ozonated Oil

    Zinc Oxide Ozonated Oil

  • OtherModified Triple Antibiotic Paste

    Modified Triple Antibiotic Paste

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 3,6,9,12 months

  2. 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

    Time frame: 3,6,9,12 months follow up

Secondary outcomes

  1. secondary out come

    evaluate lesion sterlization and tissue repair by (Zn-OO)as a substitute to pulpectomy

    Time frame: 12 months follow up

07

Study locations

2 of 2 sites recruiting
  • Faculty of dentistry Tanta university
    Tanta, Garbia +20, Egypt
    Recruiting
    • nouran esmail shalaby · ContactPG_167682@dent.tanta.edu.eg · +20 01018710314
    • shimaa sh el-desouky, professor · Principal investigator
    • fatma ab el-hendawy, professor · Sub investigator
    • nancy mo metwally, doctor · Sub investigator
  • Nouran Esmail Mohamed Shalaby
    Minūf, +20, Egypt
    Recruiting
    • esmail shalaby · ContactPG_167682@dent.tanta.edu.eg · +20 01018710314
    • shimaa sh el-desouky, professor · Principal investigator
    • fatma ab el-hendawy, professor · Sub investigator
    • nancy mo metwally, doctor · Sub investigator
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2024 (actual). Primary completion is estimated for Feb 2025, 13 months after the start.

Of 60 non-industry interventional studies with no phase under Dental Pulp Diseases, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 34. This study's planned 13 months is below that.

Counting every sponsor, half of 60 studies reached it within 18 months; a quarter within 9 and three quarters within 34.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 18, 2025
First posted
Mar 3, 2025
StartActual
Jan 15, 2024
Primary completionEst.
Feb 2025
CompletionEst.
Apr 2025
Last update
Mar 3, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06854744
Lead sponsor
Tanta University
Responsible party
Nouran Esmail Mohamed Shalaby (Zinc Oxide Ozonated Oil Versus Modified Triple Antibiotic Paste as a Lesion Sterilization and Tissue Repair Technique in Primary Molars, Tanta University) — Principal investigator
First posted
Mar 3, 2025
Start date
Jan 15, 2024
Primary completion
Feb 2025 (estimated)
Completion
Apr 2025 (estimated)
Last update
Mar 3, 2025

Study contacts

nouran esmail shalaby, master
Contact
PG_167682@dent.tanta.edu.eg
+20 01018710314 ext. 04836440064
.ahmad al el kholy, master
Contact
PG_167682@dent.tanta.edu.eg
+20 0109552575
Shaimaa Sh El-Desokey, Professor
principal investigator · Faculty of dentistry Tanta university , tanta
Fatma el hendawy, Professor
study director · Faculty of dentistry Tanta university , Tanta
Nancy metwally, doctor
study director · Faculty of dentistry Tanta university , Tanta

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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