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
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.
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.
130 studies on the registry are indexed under Dental Pulp Diseases; 37 are open to participants now.
Browse Dental Pulp Diseases studies →10 of the 33 studies in Dental Pulp Diseases with a site in Egypt are open now. Recruiting first, the newest first:
British University In Egypt · Sites in Egypt
Ages 18–50 · Healthy volunteers
British University In Egypt · Sites in Egypt
Ages 21–49 · Healthy volunteers
Tanta University · Sites in Egypt
Ages 18–40 · Healthy volunteers
Tanta University · Sites in Egypt
Ages 19–60 · Healthy volunteers
Minia University · Sites in Egypt
Ages 36 mo–47 mo · Healthy volunteers
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 →
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.
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33 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 5 · Phase 3 2 · Phase 4 2
First in 2014; this study’s year is marked. 5 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 30 is below the median of 52 across 108 interventional studies indexed under Dental Pulp Diseases.
Median enrollment 45 across the 31 interventional studies, 218 across the 2 observational. Of the 19 that completed or were terminated, 0 (0%) have results posted.
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None of the 33 has an industry lead sponsor. The 10 most frequent:
Tanta University is the lead sponsor of 1,010 studies on the registry; 321 are open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Tanta University has 4 studies filed under Dental Pulp Diseases — fewer than ten, so there is no comparison to draw.
1 of the studies in Dental Pulp Diseases with a site in Egypt that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07675330Cairo UniversityOxymetazoline Versus Sodium Hypochlorite as Hemostatic Agents in MTA Pulpotomy of Primary Molars | 2026-12 |
Among the 33 studies in Dental Pulp Diseases with a site in Egypt, from their registry updates:
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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
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.
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:
Furcation involvement less than or equal to half of the shortest root in the vertical dimension
-
Exclusion Criteria: Exclusion criteria :
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 (MTAP)as a Lesion Sterilization and Tissue Repair Technique in Primary Molars
Procedure: lesion sterlization and tissue repair · Other: Modified Triple Antibiotic Paste
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
Zinc Oxide Ozonated Oil
Modified Triple Antibiotic Paste
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
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 out come
evaluate lesion sterlization and tissue repair by (Zn-OO)as a substitute to pulpectomy
Time frame: 12 months follow up
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.
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