Pain, PostoperativeNCT06158451
Clinical and Radiographic Evaluation of Zinc Oxide-Propolis Mixture Versus Modified Triple Antibiotic Paste in LSTR
A study testing Zinc oxide propolis and Modified triple antibiotic paste in people with Pain, Postoperative and Periapical; Infection, run by Cairo University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 4 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative, Periapical; Infection
- What is being tested?
- Zinc oxide propolis and Modified triple antibiotic paste
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2024to 31 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children:
- Cooperative children aged 4 -7 years old.
- Systemically healthy.
- Teeth:
- Clinical criteria:
- Necrotic primary mandibular second molar teeth.
Show all 12Show fewer
- Spontaneous pain or tenderness to percussion
- Deep carious lesion with pulp exposure.
- Presence of chronic apical abscess or sinus tract Tooth should be restorable. (Thakur et al., 2021)
- Radiographic criteria:
- Coronal-radiographic evidence of a deep carious lesions or lesion approximating pulp
- Radicular discontinuity of lamina dura, furcation involvement less than or equal to half of shortest root in vertical dimension. (Thakur et al., 2021)
Who cannot join
- Children:
- With physical or emotional alteration.
- Children with systemic disease.
- Previous history of allergy to antibiotics used in the study.
- Children that will not attend follow up. • Teeth:
- <!-- -->
- Non restorable carious primary molars.
- Grade III mobility
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical and Radiographic Evaluation of Zinc Oxide-Propolis Mixture Versus Modified Triple Antibiotic Paste in Lesion Sterilization and Tissue Repair (LSTR) for the Treatment of Necrotic Primary Molars: A Randomized Clinical Trial
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.
Read the detailed 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.
- Conditions
- Pain, Postoperative, Periapical; Infection
- Being tested
- Zinc oxide propolis, Modified triple antibiotic paste
- Keywords
- propolis, modified triple antibiotic paste, lesion sterilization and tissue repair
- Medical subject headings
- Pain, Postoperative, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zinc oxide propolisCombination product
Propolis liquid (Brazilian Green Bee Propolis Liquid Extract, Uniflora®) and Zinc oxide powder will be mixed on a glass slab with the help of a stainless -steel spatula.
- The mixing ratio of zinc oxide powder and Propolis liquid is 2:1 until a paste like consistency is reached.
Modified triple antibiotic pasteCombination product
Chemotherapeutic agents used are 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).
- After the removal of enteric coating of tablets with the help of blade, the drugs are pulverized into fine powder using sterilized mortar and pestle.
- The same amount of each powdered drug (1:1:1) is mixed to form m-TAP powder which is mixed with one part of propylene glycol (P) and the same volume of macrogol (M) to form a paste like consistency
| Study group | Role | What they receive |
|---|---|---|
| Zinc-oxide Propolis (Zno-P) | Experimental | 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. Receives: Combination Product: Zinc oxide propolis |
| Modified triple antibiotic paste | Active comparator | 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. Receives: Combination Product: Modified triple antibiotic paste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
Binary outcome measured with direct questioning to the patient
Measured: 1 year
Tenderness to percussion
(binary outcome measured by percussion test using back of the dental mirror
Measured: 1 year
Swelling / sinus tract
binary outcome measured with visual examination of the patient examination of the patient
Measured: 1 year
Mobility
(measured by mobility test) and according to Miller's Grades; reduction in grade of mobility from preoperative baseline was treated as success
Measured: 1 year
Secondary outcomes (1)
Radiographic success
The amount of furcation / periapical radiolucency in comparison to preoperative remained static or decreased
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2023
- Study start1 Mar 2024 (estimated)
- Primary completion30 Aug 2024 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Khaled Adam, Cairo University
- Investigators
- Sherine Badr, Professor, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06158451
- Sponsor's protocol ID
- 208877371
- Status last verified
- Feb 2024
- First submitted
- 28 Nov 2023
- Last updated
- 7 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data may be provided upon request
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Zinc Oxide-Propolis Mixture Versus Modified Triple Antibiotic Paste in Lesion Sterilization and Tissue Repair (LSTR) for the Treatment of Necrotic Primary Molars: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06158451
- Acronym / sponsor ID
- 208877371
- Conditions
- Pain, Postoperative, Periapical; Infection
- Keywords
- propolis, modified triple antibiotic paste, lesion sterilization and tissue repair
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 30 Aug 2024 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 6 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zinc-oxide Propolis (Zno-P) | Experimental | Combination Product: Zinc oxide propolisPropolis 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. |
| Modified triple antibiotic paste | Active comparator | Combination Product: Modified triple antibiotic pasteMetronidazole 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. |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- Children:
- Teeth:
- Necrotic primary mandibular second molar teeth.
- Spontaneous pain or tenderness to percussion
- Deep carious lesion with pulp exposure.
Key exclusion criteria (8 listed)
- Children:
- <!-- -->
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zinc oxide propolisPropolis liquid (Brazilian Green Bee Propolis Liquid Extract, Uniflora®) and Zinc oxide powder will be mixed on a glass slab with the help of a stainless -steel spatula. • The mixing ratio of zinc oxide powder and Propolis liquid is 2:1 until a paste like consistency is reached. | Combination product | Zinc-oxide Propolis (Zno-P) |
| Modified triple antibiotic pasteChemotherapeutic agents used are 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). * After the removal of enteric coating of tablets with the help of blade, the drugs are pulverized into fine powder using sterilized mortar and pestle. * The same amount of each powdered drug (1:1:1) is mixed to form m-TAP powder which is mixed with one part of propylene glycol (P) and the same volume of macrogol (M) to form a paste like consistency | Combination product | Modified triple antibiotic paste |
Primary outcome
Postoperative pain
Time frame: 1 year
Binary outcome measured with direct questioning to the patient
Tenderness to percussion
Time frame: 1 year
(binary outcome measured by percussion test using back of the dental mirror
Swelling / sinus tract
Time frame: 1 year
binary outcome measured with visual examination of the patient examination of the patient
Mobility
Time frame: 1 year
(measured by mobility test) and according to Miller's Grades; reduction in grade of mobility from preoperative baseline was treated as success
1 secondary outcome
Radiographic success
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Individual participant dataSharing planned: No. Data may be provided upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sherine Badr, Professor study director
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing Zinc oxide propolis and Modified triple antibiotic paste in people with Pain, Postoperative and Periapical; Infection, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sara Kh Adam, Master (01221709929, sara.khaled@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain (time frame: 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.