Necrotic PulpPhase 43-mixtatinNCT03084601
Evaluation of Postoperative Pain After Using 3MIX-TATIN Versus Calcium Hydroxide Iodoform Paste In Necrotic Primary Molars Treated by Lesion Sterilization and Tissue Repair Therapy
A Phase 4 study testing Calcium Hydroxide, Iodoform, paste and 3-mixtatin in people with Necrotic Pulp and Postoperative Pain, run by Mahmoud M Saadoon at 1 site in Egypt.
Trial summary
The aim of the current study is to compare a newly introduced material which is a combination of triple mix antibiotics paste and anti-hyperlipidemia drug simvastatin, the new material is named 3MIX-TATIN \& will be compared to triple antibiotic paste for management of necrotic primary molars by using lesion… Read more about this study
- Who is it for?
- Ages 5 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Necrotic Pulp, Postoperative Pain
- What is being tested?
- Calcium Hydroxide, Iodoform, paste and 3-mixtatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2017to 1 Mar 2018
- Phase
- Phase 4
- 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 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children age range from 5-8 years.
- Children free from any systemic diseases or medical problems.
- Primary molar with necrotic pulp, with pain, gingival abscess, fistula openings, or 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
Pedodontic Department Cairo University
Cairo Governorate, Cairo Governorate, 002
About this study
Official title: Evaluation of Postoperative Pain After Using 3MIX-TATIN Versus Calcium Hydroxide Iodoform Paste In Necrotic Primary Molars Treated by Lesion Sterilization and Tissue Repair Therapy: A Randomized Controlled Trial
The aim of the current study is to compare a newly introduced material which is a combination of triple mix antibiotics paste and anti-hyperlipidemia drug simvastatin, the new material is named 3MIX-TATIN \& will be compared to triple antibiotic paste for management of necrotic primary molars by using lesion sterilization and tissue repair LSTR technique.
Read the detailed description
3Mix-tatin will 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 3Mixtatin will be trained and supervised by an expert pharmacist. 3Mixtatin will be stored in a tightly capped porcelain container, adding a small amount of silica gel in a bag inside the container to maintain low humidity. This powder will be mixed with normal saline to form a creamy paste of 3Mixtatin at the time of application.
Local anesthesia using mepivicaine hydrochloride 3% (septodont, saint-maurdesFosses, France) will be administered.
Rubber dam isolation.
Access cavity will be prepared with a fissure bur in a high-speed handpiece, necrotic pulp tissue will be removed using a sterile sharp spoon excavator.
The canal orifices will be enlarged with a round bur (one mm diameter and two mm depth) to create medication receptacles.
Cotton pellet moistened with 2.5% sodium hypochlorite (NaOCl) will be placed in the pulp chamber for 1 minute.
Bleeding, if present, will be controlled by applying sterile cotton pellet moistened with 10% sodium hypochlorite against the pulp stumps and will be maintained for 1 min.
The 3-Mix-Tatin will be mixed with saline to obtain a creamy mix and placed over the canal orifices and the pulpal floor.
The access opening will be sealed with a glass ionomer cement , and the tooth will be restored with a stainless steel crown.
- Conditions
- Necrotic Pulp, Postoperative Pain
- Being tested
- Calcium Hydroxide, Iodoform, paste, 3-mixtatin
- Medical subject headings
- Dental Pulp Necrosis, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium Hydroxide, Iodoform, pasteDrug
Also called metapex
mixture of calcium hydroxide and iodoform
3-mixtatinDrug
Also called 3mixtatin
3-mixtatin mixture of ciprofloxacin, metronidazole, cefixime, and simvastatin
| Study group | Role | What they receive |
|---|---|---|
| calcium hydroxide iodoform paste | Active comparator | intervention administered to control group is a combination of drugs as follow: ciprofloxacin 500mg, cefixime 500 mg, metronidazole 500 mg, simvastain 40mg. all are mixed, placed in pulp chamber only one time and tooth is restored Receives: Drug: 3-mixtatin |
| 3-mixtatin | Experimental | intervention administered to experimental group is a ready made mixture of calcium hydroxide and iodoform, placed in pulp chamber only one time and tooth is restored Receives: Drug: Calcium Hydroxide, Iodoform, paste |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain
measurment of post-operative pain by a questionnaire either present or absent
Measured: at 3rd months
Secondary outcomes (6)
swelling
visual inspection either present or absent
Measured: at 3rd month
swelling
visual inspection either present or absent
Measured: at 6th month
swelling
visual inspection either present or absent
Measured: at 9th month
mobility
visual inspection either present or absent
Measured: at 3rd month
mobility
visual inspection either present or absent
Measured: at 6th month
mobility
visual inspection either present or absent
Measured: at 9th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2017
- Study start1 Mar 2017
- Primary completion1 Jan 2018
- Study completion1 Mar 2018
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.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahmoud M Saadoon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mahmoud M Saadoon, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03084601
- Sponsor's protocol ID
- mahmoud 3-mixtatin
- Acronym
- 3-mixtatin
- Status last verified
- Oct 2018
- First submitted
- 13 Feb 2017
- Last updated
- 26 Oct 2018
- 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 26 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Postoperative Pain After Using 3MIX-TATIN Versus Calcium Hydroxide Iodoform Paste In Necrotic Primary Molars Treated by Lesion Sterilization and Tissue Repair Therapy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03084601
- Acronym / sponsor ID
- 3-mixtatin / mahmoud 3-mixtatin
- Conditions
- Necrotic Pulp, Postoperative Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Mahmoud M SaadoonUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 1 Mar 2018 (actual)
- First posted
- 21 Mar 2017 (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 the current study is to compare a newly introduced material which is a combination of triple mix antibiotics paste and anti-hyperlipidemia drug simvastatin, the new material is named 3MIX-TATIN \& will be compared to triple antibiotic paste for management of necrotic primary molars by using lesion sterilization and tissue repair LSTR technique.
Detailed description
3Mix-tatin will 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 3Mixtatin will be trained and supervised by an expert pharmacist. 3Mixtatin will be stored in a tightly capped porcelain container, adding a small amount of silica gel in a bag inside the container to maintain low humidity. This powder will be mixed with normal saline to form a creamy paste of 3Mixtatin at the time of application.
Local anesthesia using mepivicaine hydrochloride 3% (septodont, saint-maurdesFosses, France) will be administered.
Rubber dam isolation.
Access cavity will be prepared with a fissure bur in a high-speed handpiece, necrotic pulp tissue will be removed using a sterile sharp spoon excavator.
The canal orifices will be enlarged with a round bur (one mm diameter and two mm depth) to create medication receptacles.
Cotton pellet moistened with 2.5% sodium hypochlorite (NaOCl) will be placed in the pulp chamber for 1 minute.
Bleeding, if present, will be controlled by applying sterile cotton pellet moistened with 10% sodium hypochlorite against the pulp stumps and will be maintained for 1 min.
The 3-Mix-Tatin will be mixed with saline to obtain a creamy mix and placed over the canal orifices and the pulpal floor.
The access opening will be sealed with a glass ionomer cement , and the tooth will be restored with a stainless steel crown.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| calcium hydroxide iodoform paste | Active comparator | Drug: 3-mixtatinintervention administered to control group is a combination of drugs as follow: ciprofloxacin 500mg, cefixime 500 mg, metronidazole 500 mg, simvastain 40mg. all are mixed, placed in pulp chamber only one time and tooth is restored |
| 3-mixtatin | Experimental | Drug: Calcium Hydroxide, Iodoform, pasteintervention administered to experimental group is a ready made mixture of calcium hydroxide and iodoform, placed in pulp chamber only one time and tooth is restored |
Who may qualify
- Ages
- 5 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children age range from 5-8 years.
- Children free from any systemic diseases or medical problems.
- Primary molar with necrotic pulp, with pain, gingival abscess, fistula openings, or 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.
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 |
|---|---|---|
| Calcium Hydroxide, Iodoform, pasteAlso: metapexmixture of calcium hydroxide and iodoform | Drug | 3-mixtatin |
| 3-mixtatinAlso: 3mixtatin3-mixtatin mixture of ciprofloxacin, metronidazole, cefixime, and simvastatin | Drug | calcium hydroxide iodoform paste |
Primary outcome
pain
Time frame: at 3rd months
measurment of post-operative pain by a questionnaire either present or absent
6 secondary outcomes
swelling
Time frame: at 3rd month
swelling
Time frame: at 6th month
swelling
Time frame: at 9th month
mobility
Time frame: at 3rd month
mobility
Time frame: at 6th month
mobility
Time frame: at 9th month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2018.
- Individual participant dataSharing planned: No
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Post Operative Pain, Acute, Irreversible Pulpitis (Toothache)
Not yet recruiting
PRP-Assisted Regenerative Endodontics Versus Conventional Root Canal Treatment in Mature Necrotic Teeth
Pulp Necrosis, Apical Periodontitis
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Influence of Continuous Rotation Versus Reciprocation Motion of MG3 Blue Rotary File on Postoperative Pain and Intracanal Bacterial Reduction of Teeth With Necrotic Pulps.
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Not yet recruiting
Clinical and Inflammatory Outcomes of Regenerative Endodontic Treatment Using Injectable Platelet-Rich Fibrin in Mature Necrotic Teeth With Chronic Apical Periodontitis.
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Recruiting
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Calcium Hydroxide, Iodoform, paste and 3-mixtatin in people with Necrotic Pulp and Postoperative Pain, run by Mahmoud M Saadoon 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 4 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: finished, as of the sponsor's last update on 26 Oct 2018. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain (time frame: at 3rd 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 26 Oct 2018.