Necrotic PulpNCT06752889
Clinical and Radiographic Evaluation of Zinc Oxide Modified 3Mixtatin Versus Zical in Root Canal Treatment of Necrotic Primary Molars.
A study testing Group ( 2) Experimental group modified 3-MIX-TATIN): in people with Necrotic Pulp and Primary Teeth, run by Ain Shams University at 1 site in Egypt.
Trial summary
Primary molars with necrotic pulp or abscess are common unfortunate event faced in pediatric dentistry .The traditional treatment is either pulpectomy or extraction. ٍuccess of pulpectomy treatment is about 85% in abscessed primary teeth. Read more about this study
- Who is it for?
- Ages 5 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Necrotic Pulp, Primary Teeth
- What is being tested?
- Group ( 2) Experimental group modified 3-MIX-TATIN):
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to Feb 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 5 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children age range from 5-7 years.
- Children free from any systemic diseases or genetic disorders.
- Primary molar with necrotic pulp, with pain, gingival abscess, sinus openings.
- Clinical mobility not exceeding grade two.
- Radiographic evidence of non-perforating internal resorption, external resorption not exceeding 1\3 of the root
- Furcation or periapical radiolucency.
Who cannot join
- Non-restorable molars or beyond repair, for example: decay reaches to bifurcation, a hard gingival margin cannot be established or infection cannot be eradicated by other mean (Balaji, 2007).
- Patient with known allergy to any type of antibiotics or anti-hyperlipidemia drugs.
- Patient with facial cellulitis or lymphadenopathy
- Lack of patient/parent compliance and cooperation.
- Refusal of participation or failure to obtain an informed consent.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University
Cairo, Cairo Governorate, 002
AIN SHAMS AIN SHAMS, mahmoud_magdy@dentistry.cu.edu.eg
About this study
Official title: Clinical and Radiographic Evaluation of Zinc Oxide Modified 3Mixtatin Versus Zical Root Canal Sealer in Root Canal Treatment of Necrotic Primary Molars.(A Randomized Clinical Trial and in Vitro Study)
Primary molars with necrotic pulp or abscess are common unfortunate event faced in pediatric dentistry .The traditional treatment is either pulpectomy or extraction. ٍuccess of pulpectomy treatment is about 85% in abscessed primary teeth.
The aim of pulpectomy is to preserve teeth in a symptom free state until they are replaced by their successor naturally during the transition from primary to permanent dentition, thus avoiding extraction. The adequate restoration of the involved teeth may preserve the arch length reestablish the masticatory function and esthetics and prevent harmful tongue habits and speech alterations due to anterior teeth decay.
Read the detailed description
The techniques available for management of necrotic primary molars are either pulpectomy or extraction, but according to guidelines American Academy of Pediatric Dentistry, extraction and space maintainer is a viable option but a successfully restored tooth is far superior space maintainer than an appliance. So preservation of primary molars is not only important for masticatory function but also for preservation of developing occlusion.
The rationale includes the chemical and mechanical removal of irreversibly inflamed or necrotic radicular pulp tissue, followed by root canal filling with a material that can resorb at the same rate as the primary tooth and be eliminated rapidly if accidentally extruded through the apex and have the ability for disinfection of pulpal and periapical lesion.
In this study 2 medications will be used as root canal filling. First is the mixture of zinc oxide eugenol based sealer (ZicalR) and 3mixtatin which is composed of 3 antibiotics (ciprofloxacin, cefixime, metronidazole), simvastatin, and zinc oxide the term 3mix-tatin as an acronym for the mixture of triple mixture antibiotics and simvastatin. Statin components are emerging material in regenerative endodontics. Clinical and experimental trials proved the pleiotropic effect of statin, as it increases the osteoblastic function and suppresses the osteoclastic function. In addition to that, evidence proved that it is a potent anti -inflammatory as it reduce the CRP and pro-inflammatory cytokines. Second medication will be Zical which is a zinc oxide eugenol based sealer composed of Zinc Oxide, Bismuth Sub-carbonate, Barium Sulphate, Sodium Borate, Iodoform, and Hydrogenated Resin. Liquid contains: Eugenol.
- Conditions
- Necrotic Pulp, Primary Teeth
- Being tested
- Group( 1): Control Group (pulpectomy using zic oxide eugenol based sealer Zical):, Group ( 2) Experimental group modified 3-MIX-TATIN):
- Medical subject headings
- Dental Pulp Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group( 1): Control Group (pulpectomy using zic oxide eugenol based sealer Zical):Other
Zinc oxide eugenol based sealer (Zical) will be mixed into a thick paste and packed into the pulp chamber to fill the canal.
Group ( 2) Experimental group modified 3-MIX-TATIN):Other
Modified 3Mix-tatin will be prepared by mixing three commercially available antibiotics with simvastatin. This powder will be mixed with zinc oxide eugenol based sealer called Zical which will act as a carrier or vehicle to form a creamy paste of 3Mixtatin at the time of application
| Study group | Role | What they receive |
|---|---|---|
| Group( 1): Control Group (pulpectomy using zic oxide eugenol based sealer Zical): | Active comparator | Local anesthesia administration and rubber dam isolation will be carried out Access cavity will be prepared, necrotic pulp tissue will be removed using a sterile sharp spoon excavator.
Cleaning and shaping of the root canals will be carried out using H files and continuous irrigation.
Canal irrigation with 2.5% sodium hypochlorite will be carried out throughout the procedure.
Sterile paper points will be used to dry the root canals. Zinc oxide eugenol based sealer (Zical) will be mixed into a thick paste and packed into the pulp chamber to fill the canal. (Chen\& Zhong., 2017; Pramila., 2015) The access opening will be sealed with a glass ionomer cement , and the tooth will be restored with a stainless steel crown. Receives: Other: Group( 1): Control Group (pulpectomy using zic oxide eugenol based sealer Zical): |
| Group ( 2) Experimental group modified 3-MIX-TATIN): | Experimental | dified 3Mix-tatin will be prepared by mixing three commercially available antibiotics with simvastatin. After removing the coating materials, 3 types of antibiotics are pulverized by porcelain mortars and pestles to achieve fine powders. A total of 100 mg ciprofloxacin, 100 mg metronidazole, and 100 mg cefixime will be mixed in a ratio of 1: 1: 1. Two milligrams of simvastatin will be added to the drugs blend to form 3-Mix-tatin. Preparation of 3Mix-tatin will be trained and supervised by an expert pharmacist. 3Mixtatin will be stored in a tightly capped porcelain container, adding of silica gel in a bag inside the container to maintain low humidity. This powder will be mixed with zinc oxide eugenol based sealer called Zical which will act as a carrier or vehicle to form a creamy paste of 3Mixtatin at the time of application (Aminabadi et al., 2015; carvalho., 2016). Receives: Other: Group ( 2) Experimental group modified 3-MIX-TATIN): |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain
spontaneous pain, as reported by the caregivers through visual analogue score (VAS)from 1 to 10 where 1 means : minimal pain , 10 means:: severe pain
Measured: first week after treatment, 3 months, 6 months, 12 months
Secondary outcomes (2)
Root resorption
Presence of Radiographic internal or external root resorption in periapical radiograph using parallel technique
Measured: preoperative, 3rd month, 6 month, 12 month
Bone resorption
Presence of Radiographic bone resorption in periapical radiograph technique of Radiograph: extension cone paralelling periapical radiograph (XCP)
Measured: preoperative, 3 , 6 , 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2024
- Study start1 Jan 2024
- Primary completionJan 2025 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Necrotic PulpStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- amira badran, Phd, Study director, associate professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06752889
- Sponsor's protocol ID
- PED21-9
- Status last verified
- Mar 2024
- First submitted
- 29 Mar 2024
- Last updated
- 31 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Zinc Oxide Modified 3Mixtatin Versus Zical Root Canal Sealer in Root Canal Treatment of Necrotic Primary Molars.(A Randomized Clinical Trial and in Vitro Study)
- ClinicalTrials.gov ID
- NCT06752889
- Acronym / sponsor ID
- PED21-9
- Conditions
- Necrotic Pulp, Primary Teeth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 31 Dec 2024 (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.
Primary molars with necrotic pulp or abscess are common unfortunate event faced in pediatric dentistry .The traditional treatment is either pulpectomy or extraction. ٍuccess of pulpectomy treatment is about 85% in abscessed primary teeth.
The aim of pulpectomy is to preserve teeth in a symptom free state until they are replaced by their successor naturally during the transition from primary to permanent dentition, thus avoiding extraction. The adequate restoration of the involved teeth may preserve the arch length reestablish the masticatory function and esthetics and prevent harmful tongue habits and speech alterations due to anterior teeth decay.
Detailed description
The techniques available for management of necrotic primary molars are either pulpectomy or extraction, but according to guidelines American Academy of Pediatric Dentistry, extraction and space maintainer is a viable option but a successfully restored tooth is far superior space maintainer than an appliance. So preservation of primary molars is not only important for masticatory function but also for preservation of developing occlusion.
The rationale includes the chemical and mechanical removal of irreversibly inflamed or necrotic radicular pulp tissue, followed by root canal filling with a material that can resorb at the same rate as the primary tooth and be eliminated rapidly if accidentally extruded through the apex and have the ability for disinfection of pulpal and periapical lesion.
In this study 2 medications will be used as root canal filling. First is the mixture of zinc oxide eugenol based sealer (ZicalR) and 3mixtatin which is composed of 3 antibiotics (ciprofloxacin, cefixime, metronidazole), simvastatin, and zinc oxide the term 3mix-tatin as an acronym for the mixture of triple mixture antibiotics and simvastatin. Statin components are emerging material in regenerative endodontics. Clinical and experimental trials proved the pleiotropic effect of statin, as it increases the osteoblastic function and suppresses the osteoclastic function. In addition to that, evidence proved that it is a potent anti -inflammatory as it reduce the CRP and pro-inflammatory cytokines. Second medication will be Zical which is a zinc oxide eugenol based sealer composed of Zinc Oxide, Bismuth Sub-carbonate, Barium Sulphate, Sodium Borate, Iodoform, and Hydrogenated Resin. Liquid contains: Eugenol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group( 1): Control Group (pulpectomy using zic oxide eugenol based sealer Zical): | Active comparator | Other: Group( 1): Control Group (pulpectomy using zic oxide eugenol based sealer Zical):Local anesthesia administration and rubber dam isolation will be carried out Access cavity will be prepared, necrotic pulp tissue will be removed using a sterile sharp spoon excavator. Cleaning and shaping of the root canals will be carried out using H files and continuous irrigation. Canal irrigation with 2.5% sodium hypochlorite will be carried out throughout the procedure. Sterile paper points will be used to dry the root canals. Zinc oxide eugenol based sealer (Zical) will be mixed into a thick paste and packed into the pulp chamber to fill the canal. (Chen\& Zhong., 2017; Pramila., 2015) The access opening will be sealed with a glass ionomer cement , and the tooth will be restored with a stainless steel crown. |
| Group ( 2) Experimental group modified 3-MIX-TATIN): | Experimental | Other: Group ( 2) Experimental group modified 3-MIX-TATIN):dified 3Mix-tatin will be prepared by mixing three commercially available antibiotics with simvastatin. After removing the coating materials, 3 types of antibiotics are pulverized by porcelain mortars and pestles to achieve fine powders. A total of 100 mg ciprofloxacin, 100 mg metronidazole, and 100 mg cefixime will be mixed in a ratio of 1: 1: 1. Two milligrams of simvastatin will be added to the drugs blend to form 3-Mix-tatin. Preparation of 3Mix-tatin will be trained and supervised by an expert pharmacist. 3Mixtatin will be stored in a tightly capped porcelain container, adding of silica gel in a bag inside the container to maintain low humidity. This powder will be mixed with zinc oxide eugenol based sealer called Zical which will act as a carrier or vehicle to form a creamy paste of 3Mixtatin at the time of application (Aminabadi et al., 2015; carvalho., 2016). |
Who may qualify
- Ages
- 5 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Children age range from 5-7 years.
- Children free from any systemic diseases or genetic disorders.
- Primary molar with necrotic pulp, with pain, gingival abscess, sinus openings.
- Clinical mobility not exceeding grade two.
- Radiographic evidence of non-perforating internal resorption, external resorption not exceeding 1\3 of the root
Key exclusion criteria (5 listed)
- Non-restorable molars or beyond repair, for example: decay reaches to bifurcation, a hard gingival margin cannot be established or infection cannot be eradicated by other mean (Balaji, 2007).
- Patient with known allergy to any type of antibiotics or anti-hyperlipidemia drugs.
- Patient with facial cellulitis or lymphadenopathy
- Lack of patient/parent compliance and cooperation.
- Refusal of participation or failure to obtain an informed consent.
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 |
|---|---|---|
| Group( 1): Control Group (pulpectomy using zic oxide eugenol based sealer Zical):Zinc oxide eugenol based sealer (Zical) will be mixed into a thick paste and packed into the pulp chamber to fill the canal. | Other | Group( 1): Control Group (pulpectomy using zic oxide eugenol based sealer Zical): |
| Group ( 2) Experimental group modified 3-MIX-TATIN):Modified 3Mix-tatin will be prepared by mixing three commercially available antibiotics with simvastatin. This powder will be mixed with zinc oxide eugenol based sealer called Zical which will act as a carrier or vehicle to form a creamy paste of 3Mixtatin at the time of application | Other | Group ( 2) Experimental group modified 3-MIX-TATIN): |
Primary outcome
postoperative pain
Time frame: first week after treatment, 3 months, 6 months, 12 months
spontaneous pain, as reported by the caregivers through visual analogue score (VAS)from 1 to 10 where 1 means : minimal pain , 10 means:: severe pain
2 secondary outcomes
Root resorption
Time frame: preoperative, 3rd month, 6 month, 12 month
Bone resorption
Time frame: preoperative, 3 , 6 , 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Necrotic Pulp
Not yet recruiting
Influence of Continuous Rotation Versus Reciprocation Motion of MG3 Blue Rotary File on Postoperative Pain and Intracanal Bacterial Reduction of Teeth With Necrotic Pulps.
Necrotic Pulps With no Apical Periodontitis
Enrolling by invitation
Evaluation of Different Medicaments in the Management of Necrotic Primary Molars by Lesion Sterilization and Tissue Repair
Pain, Postoperative, Root Resorption
Not yet recruiting
Comparison of Post-operative Pain and Levels of MMP -9 Following Root Canal Irrigation With Sodium Hypochlorite Versus Cold Atmospheric Plasma in Patient With Necrotic Single Rooted Teeth: Randomized Clinical Trial
Necrotic Pulp
Active, not recruiting
The Impact of Using Different Final Irrigation Modes on Postoperative Pain Following Root Canal Treatment of Non-vital Mandibular First Molar With Periapical Lesion.
Necrotic Pulp With Symptomatic Apical Periodontitis
Active, not recruiting
Evaluation of the Impact of Different Final Irrigation Activation Modes on Healing of Periapical Lesions Related to Permanent Mandibular First Molars Using CBCT.
Necrotic Pulp With Symptomatic Apical Periodontitis
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.
amira badran, Phd study director
associate professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group ( 2) Experimental group modified 3-MIX-TATIN): in people with Necrotic Pulp and Primary Teeth, run by Ain Shams University at 1 site in Egypt.
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 6 inclusion and 5 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 31 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Mahmoud Sa'adoon, master (201115082428, drmahmoudsa3doon@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative pain (time frame: first week after treatment, 3 months, 6 months, 12 months). 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 31 Dec 2024; AzTrials last refreshed its copy on 8 Nov 2026.