Dental Pulp CavityPhase 3NCT04547764
Evaluation of Triple Antibiotic Paste Pulp Therapy Compared to Vitapex in Primary Molars.
A Phase 3 study testing triple antibiotic paste (TAP) and Vitapex (calcium hydroxide/iodoform paste) in people with Dental Pulp Cavity, run by King Abdulaziz University at 1 site in Saudi Arabia.
Trial summary
The aim of the study was to compare the clinical and radiographic success of triple antibiotic paste (TAP) which includes (metronidazole, ciprofloxacin, and minocycline) and Vitapex (calcium hydroxide/iodoform paste) for root canal treatment of pulpally involved teeth. Read more about this study
- Who is it for?
- Ages 5 to 8 years
- Conditions the study is for
- Dental Pulp Cavity
- What is being tested?
- triple antibiotic paste (TAP) and Vitapex (calcium hydroxide/iodoform paste)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Jun 2017to 30 Dec 2018
- Phase
- Phase 3
- 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
- No healthy volunteers
- Child
Who may be able to join
- Primary molars with at least one of the following signs and symptoms were eligible and were included in the study:
- badly decayed with signs of irreversible pulpitis,
- necrosis and chronic infection such as: pain or tenderness to percussion and palpation, abscess, fistula-opening, gingival swelling, grade II and greater pathological tooth mobility, evidence of periapical/bifurcation radiolucency,
- All the teeth included, had physiological root resorption of less than one third of the root.
Who cannot join
- Teeth showing radiographic evidence of excessive internal or external root resorption,
- perforated pulpal floor,
- excessive bone loss in furcation area involving the underlying tooth germ,
- non- restorable teeth were excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Radiographic Evaluation of Triple Antibiotic Paste Pulp Therapy Compared to Vitapex Pulpectomy in Non-vital Primary Molars.
The aim of the study was to compare the clinical and radiographic success of triple antibiotic paste (TAP) which includes (metronidazole, ciprofloxacin, and minocycline) and Vitapex (calcium hydroxide/iodoform paste) for root canal treatment of pulpally involved teeth.
Read the detailed description
This study evaluated and compared the clinical and radiographic efficacy of non-instrumentation triple antibiotic paste pulp therapy (TAP) versus Vitapex pulpectomy in non-vital primary molars. Healthy 5 to 9 years old children with at least one non-vital primary molar were included in the study. molars were divided based on the subject's cooperation level and parental preference into two groups. In the first group, molars received TAP and in the second group, they received Vitapex pulpectomy followed by a stainless-steel crown. The TAP was freshly prepared and proportioned in equal parts by volume (metronidazole, minocycline, and ciprofloxacin=1:1:1) before the scheduled treatment appointment. The clinical and radiographic examination was performed by two calibrated and trained pediatric dentists at the pre-operative baseline and at the six- and 12-months follow-up visits.
- Conditions
- Dental Pulp Cavity
- Being tested
- triple antibiotic paste (TAP), Vitapex (calcium hydroxide/iodoform paste)
- Keywords
- Deciduous teeth, endodontic treatment, primary molars, pulpectomy.
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
triple antibiotic paste (TAP)Drug
root canal treatment of pulpally involved teeth.
Vitapex (calcium hydroxide/iodoform paste)Drug
root canal treatment of pulpally involved teeth.
| Study group | Role | What they receive |
|---|---|---|
| TAP group | Experimental | Not described Receives: Drug: triple antibiotic paste (TAP) |
| Vitapex group | Active comparator | Not described Receives: Drug: Vitapex (calcium hydroxide/iodoform paste) |
What is being measured
The primary outcome is the main question the study is designed to answer.
fissure-exact test
The success rate of case and control groups, at 6 and 12 months follow-ups, are compared by Fissure-Exact Test.
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study start1 Jun 2017
- Primary completion1 Dec 2018
- Study completion30 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Pulp CavityStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Abdulaziz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba sabbagh, King Abdulaziz University
- Investigators
- heba sabbagh, PhD, Principal investigator, Assistant Professor, Department of Pediatric Dentistry King Abdulaziz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04547764
- Sponsor's protocol ID
- 067-16
- Status last verified
- Sep 2020
- First submitted
- 11 Jul 2020
- Last updated
- 14 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Triple Antibiotic Paste Pulp Therapy Compared to Vitapex Pulpectomy in Non-vital Primary Molars.
- ClinicalTrials.gov ID
- NCT04547764
- Acronym / sponsor ID
- 067-16
- Conditions
- Dental Pulp Cavity
- Keywords
- Deciduous teeth, endodontic treatment, primary molars, pulpectomy.
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- King Abdulaziz UniversityUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 14 Sep 2020 (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 study was to compare the clinical and radiographic success of triple antibiotic paste (TAP) which includes (metronidazole, ciprofloxacin, and minocycline) and Vitapex (calcium hydroxide/iodoform paste) for root canal treatment of pulpally involved teeth.
Detailed description
This study evaluated and compared the clinical and radiographic efficacy of non-instrumentation triple antibiotic paste pulp therapy (TAP) versus Vitapex pulpectomy in non-vital primary molars. Healthy 5 to 9 years old children with at least one non-vital primary molar were included in the study. molars were divided based on the subject's cooperation level and parental preference into two groups. In the first group, molars received TAP and in the second group, they received Vitapex pulpectomy followed by a stainless-steel crown. The TAP was freshly prepared and proportioned in equal parts by volume (metronidazole, minocycline, and ciprofloxacin=1:1:1) before the scheduled treatment appointment. The clinical and radiographic examination was performed by two calibrated and trained pediatric dentists at the pre-operative baseline and at the six- and 12-months follow-up visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAP group | Experimental | Drug: triple antibiotic paste (TAP) |
| Vitapex group | Active comparator | Drug: Vitapex (calcium hydroxide/iodoform paste) |
Who may qualify
- Ages
- 5 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Primary molars with at least one of the following signs and symptoms were eligible and were included in the study:
- badly decayed with signs of irreversible pulpitis,
- necrosis and chronic infection such as: pain or tenderness to percussion and palpation, abscess, fistula-opening, gingival swelling, grade II and greater pathological tooth mobility, evidence of periapical/bifurcation radiolucency,
- All the teeth included, had physiological root resorption of less than one third of the root.
Key exclusion criteria (4 listed)
- Teeth showing radiographic evidence of excessive internal or external root resorption,
- perforated pulpal floor,
- excessive bone loss in furcation area involving the underlying tooth germ,
- non- restorable teeth were excluded from the study.
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 |
|---|---|---|
| triple antibiotic paste (TAP)root canal treatment of pulpally involved teeth. | Drug | TAP group |
| Vitapex (calcium hydroxide/iodoform paste)root canal treatment of pulpally involved teeth. | Drug | Vitapex group |
Primary outcome
fissure-exact test
Time frame: up to 12 months
The success rate of case and control groups, at 6 and 12 months follow-ups, are compared by Fissure-Exact Test.
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 14 Sep 2020.
Related trials for Dental Pulp Cavity
Recruiting
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Pulp Disease, Dental
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.
heba sabbagh, PhD principal investigator
Assistant Professor, Department of Pediatric Dentistry King Abdulaziz University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing triple antibiotic paste (TAP) and Vitapex (calcium hydroxide/iodoform paste) in people with Dental Pulp Cavity, run by King Abdulaziz University at 1 site in Saudi Arabia.
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 4 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 14 Sep 2020. 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 Saudi Arabia. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
fissure-exact test (time frame: up to 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 14 Sep 2020.