Periapical PeriodontitisPhase 1NCT02947763
Single Versus Multiple Visits Endodontic Treatment
A Phase 1 study testing mixture of metronidazole, ciprofloxacin, and minocycline in people with Periapical Periodontitis, run by Cairo University.
Trial summary
Healing rate after single visit or multiple visit endodontic treatment using triple paste intracanal medicament will be assessed both clinically and radio-graphically for follow-up period up to one year Read more about this study
- Who is it for?
- Ages 16 to 55 years
- Conditions the study is for
- Periapical Periodontitis
- What is being tested?
- mixture of metronidazole, ciprofloxacin, and minocycline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to Feb 2018
- Phase
- Phase 1
- 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 16 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Adult patients; age between 16-55 years old.
- Males or Females.
- Maxillary or mandibular single-root tooth or a multi-rooted tooth with:
- Non-vital response of pulp tissue.
- Radiographic evidence of periapical lesions (minimum size 2.0 mm × 2.0 mm) related to one root in case of multi-rooted teeth.
- Asymptomatic patients.
- Positive patients' acceptance for participation in the study.
Who cannot join
- Primary teeth, and permanent teeth with immature apex.
- Teeth previously accessed or endodontically treated.
- Patients with diabetes and immune-compromising disease.
- Patients allergic to metronidazole, ciprofloxacin, or minocycline.
- Vital cases or necrotic without periapical lesion.
- Pregnant women.
- Teeth with unfavorable conditions for rubber-dam application.
- Tooth associated with vertical root fracture, coronal perforation, calcification and external or internal root resorption.
About this study
Official title: Healing Rates After Single Versus Multiple Visits Endodontic Treatment of Necrotic Teeth With Apical Periodontitis: A Randomized Clinical Trial
Healing rate after single visit or multiple visit endodontic treatment using triple paste intracanal medicament will be assessed both clinically and radio-graphically for follow-up period up to one year
Read the detailed description
Patients with necrotic teeth with apical periodontitis will be selected according to the eligibility criteria and patients are then randomized to either single visit or multiple visit using triple paste intracanal medicament. Postoperative pain will then assessed using numerical rating scale after 1, 2, 3 and 7 days post-instrumentation. Radiographic healing will be assessed every 3 months up to one year.
- Conditions
- Periapical Periodontitis
- Being tested
- mixture of metronidazole, ciprofloxacin, and minocycline
- Medical subject headings
- Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mixture of metronidazole, ciprofloxacin, and minocyclineDrug
Also called no other names
placement of intracanal medication
| Study group | Role | What they receive |
|---|---|---|
| multiple visit | Active comparator | multiple visit root canal treatment with triple antibiotic paste intracanal medication (a mixture of metronidazole, ciprofloxacin, and minocycline) Receives: Drug: mixture of metronidazole, ciprofloxacin, and minocycline |
| single visit | No intervention | single visit root canal treatment without any intra-canal medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain
using numerical rating scale from 0-10
Measured: 24 hours
postoperative pain
using numerical rating scale from 0-10
Measured: 48 hours
postoperative pain
using numerical rating scale from 0-10
Measured: 72 hours
postoperative pain
using numerical rating scale from 0-10
Measured: 7 days
Secondary outcomes (4)
Radiographic healing
using digital radiography
Measured: 3 months
Radiographic healing
using digital radiography
Measured: 6 months
Radiographic healing
using digital radiography
Measured: 9 months
Radiographic healing
using digital radiography
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2016 (estimated)
- Study startNov 2016
- Primary completionJan 2018
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Periapical PeriodontitisStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Safeya AbdelRahaman Hassan, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02947763
- Sponsor's protocol ID
- CEBD-CU-2016-10-231
- Status last verified
- Jul 2019
- First submitted
- 26 Oct 2016
- Last updated
- 12 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
AbdurRahman S, Abdel Aziz SM, Gawdat SI, AbdalSamad AM. Postoperative pain of patients with necrotic teeth with apical periodontitis following single visit endodontic treatment versus multiple visit endodontic treatment using triple antibiotic paste: a randomized clinical trial. F1000Res. 2019 Jul 26;8:1203. doi: 10.12688/f1000research.19936.1. eCollection 2019.
PubMed 32047601
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healing Rates After Single Versus Multiple Visits Endodontic Treatment of Necrotic Teeth With Apical Periodontitis: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02947763
- Acronym / sponsor ID
- CEBD-CU-2016-10-231
- Conditions
- Periapical Periodontitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 28 Oct 2016 (estimated)
- 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.
Healing rate after single visit or multiple visit endodontic treatment using triple paste intracanal medicament will be assessed both clinically and radio-graphically for follow-up period up to one year
Detailed description
Patients with necrotic teeth with apical periodontitis will be selected according to the eligibility criteria and patients are then randomized to either single visit or multiple visit using triple paste intracanal medicament. Postoperative pain will then assessed using numerical rating scale after 1, 2, 3 and 7 days post-instrumentation. Radiographic healing will be assessed every 3 months up to one year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| multiple visit | Active comparator | Drug: mixture of metronidazole, ciprofloxacin, and minocyclinemultiple visit root canal treatment with triple antibiotic paste intracanal medication (a mixture of metronidazole, ciprofloxacin, and minocycline) |
| single visit | No intervention | –single visit root canal treatment without any intra-canal medication |
Who may qualify
- Ages
- 16 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Adult patients; age between 16-55 years old.
- Males or Females.
- Maxillary or mandibular single-root tooth or a multi-rooted tooth with:
- Positive patients' acceptance for participation in the study.
Key exclusion criteria (8 listed)
- Primary teeth, and permanent teeth with immature apex.
- Teeth previously accessed or endodontically treated.
- Patients with diabetes and immune-compromising disease.
- Patients allergic to metronidazole, ciprofloxacin, or minocycline.
- Vital cases or necrotic without periapical lesion.
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 |
|---|---|---|
| mixture of metronidazole, ciprofloxacin, and minocyclineAlso: no other namesplacement of intracanal medication | Drug | multiple visit |
Primary outcome
postoperative pain
Time frame: 24 hours
using numerical rating scale from 0-10
postoperative pain
Time frame: 48 hours
using numerical rating scale from 0-10
postoperative pain
Time frame: 72 hours
using numerical rating scale from 0-10
postoperative pain
Time frame: 7 days
using numerical rating scale from 0-10
4 secondary outcomes
Radiographic healing
Time frame: 3 months
Radiographic healing
Time frame: 6 months
Radiographic healing
Time frame: 9 months
Radiographic healing
Time frame: 12 months
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 12 Jul 2019.
- Derived from this study: PubMed 32047601AbdurRahman S, Abdel Aziz SM, Gawdat SI, AbdalSamad AM. Postoperative pain of patients with necrotic teeth with apical periodontitis following single visit endodontic treatment versus multiple visit endodontic treatment using triple antibiotic paste: a randomized clinical trial. F1000Res. 2019 Jul 26;8:1203. doi: 10.12688/f1000research.19936.1. eCollection 2019.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing mixture of metronidazole, ciprofloxacin, and minocycline in people with Periapical Periodontitis, 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 7 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: finished, as of the sponsor's last update on 12 Jul 2019. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
postoperative pain (time frame: 24 hours). 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?
On the ClinicalTrials.gov record for NCT02947763, which also lists 1 linked publication.
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 12 Jul 2019.