Asymptomatic Necrotic TeethPhase 1NCT02907489
Effect of Triple Antibiotic Paste as an Intracanal Medication With an Anti-Inflammatory Drug on Post-operative Pain.
A Phase 1 study testing triple antibiotic paste with an anti-inflammatory drug in people with Asymptomatic Necrotic Teeth, run by Cairo University.
Trial summary
The purpose of this study is to determine whether the use of triple antibiotic paste as intracanal medication with an anti-inflammatory drug, compared to a calcium hydroxide will reduce postoperative pain and intracanal bacteria or not in patients with asymptomatic necrotic teeth. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Asymptomatic Necrotic Teeth
- What is being tested?
- triple antibiotic paste with an anti-inflammatory drug
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to Jul 2018
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject's age between 18-50 years.
- Both male and female subjects.
- Medically free and healthy subjects.
- Mandibular and maxillary single rooted teeth.
- Asymptomatic non vital teeth.
Who cannot join
- Teeth with acute dentoalveolar abscess.
- Subjects having more than one tooth that require root canal treatment.
- Subjects that have taken analgesic, anti-inflammatory or antibiotic drugs during the 10 days prior to the start of treatment.
- Pregnant females.
- Subjects with systemic diseases who have endocrine diseases, Infectious diseases or Psychological disturbance.
- Teeth with periodontal disease or pulp calcification.
- Subjects taking chronic pain medications.
About this study
Official title: The Effect of Triple Antibiotic Paste as an Intracanal Medication With an Anti-Inflammatory Drug on Post-Operative Pain of Asymptomatic Uniradicular Necrotic Teeth (A Double Blind Randomized Clinical Trial).
The purpose of this study is to determine whether the use of triple antibiotic paste as intracanal medication with an anti-inflammatory drug, compared to a calcium hydroxide will reduce postoperative pain and intracanal bacteria or not in patients with asymptomatic necrotic teeth.
Read the detailed description
This trial is aiming to answer a clinical question whether in patients with asymptomatic necrotic teeth, the use of triple antibiotic paste as intracanal medication with an anti-inflammatory drug, compared to a calcium hydroxide, reduce postoperative pain and intracanal bacteria or not? trial design will be Randomized, controlled, double blinded, unicenter, parallel, two-arm, superiority trial with 1:1 allocation ratio.
- Conditions
- Asymptomatic Necrotic Teeth
- Being tested
- triple antibiotic paste with an anti-inflammatory drug
- Keywords
- post operative pain, triple antibiotic paste, intracanal medication
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
triple antibiotic paste with an anti-inflammatory drugOther
Mixture of ciprofloxacin, metronidazole and minocycline.and diclofenac potassium 50 mg (Catafast)
| Study group | Role | What they receive |
|---|---|---|
| Control: Calcium Hydroxide | No intervention | Non-setting Calcium Hydroxide |
| Test: Triple Antibiotic Paste and Anti-Inflammatory Drug | Other | Mixture of ciprofloxacin, metronidazole and minocycline.and diclofenac potassium 50 mg (Catafast) Receives: Other: triple antibiotic paste with an anti-inflammatory drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post Operative Pain
Visual Analogue Scale (VAS) of post operative pain (The VAS consisted of a 100 mm horizontal ruler without numbers except a "0" at its first part and a "10" in the last part. With "0" indicating the best outcome while "10" the worst outcome. The subjects were asked to mark the point that was equivalent to their pain intensity. The pain levels were classified as no pain [0], mild pain [1-3], moderate pain [4-7] or severe pain [8-10] )
Measured: after 24, 48, and 72 hour from the end of the first visit.
Secondary outcomes (1)
Intracanal Bacterial Count
Colony forming units per milliliter of blood agar medium before root canal preparation (S1), after root canal preparation (S2) and after intracanal medication application for 72 hours (S3)
Measured: before and after mechanical preparation (at day 0) and after 72 hour from placement of the intracanal medication.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2016 (estimated)
- Study startOct 2016
- Primary completionApr 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Asymptomatic Necrotic TeethStudies 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
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mohamed omaia ahmed salah, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02907489
- Sponsor's protocol ID
- CEBD-CU-2016-09-194
- Status last verified
- Sep 2019
- First submitted
- 8 Sep 2016
- Last updated
- 24 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Omaia M, Negm M, Nashaat Y, Nabil N, Othman A. The effect of triple antibiotic paste as an intracanal medicament with an anti-inflammatory agent on post-operative pain of asymptomatic uniradicular necrotic teeth: a double blind randomized clinical trial. F1000Res. 2025 Dec 16;8:1687. doi: 10.12688/f1000research.19699.3. eCollection 2019.
PubMed 41552268
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Triple Antibiotic Paste as an Intracanal Medication With an Anti-Inflammatory Drug on Post-Operative Pain of Asymptomatic Uniradicular Necrotic Teeth (A Double Blind Randomized Clinical Trial).
- ClinicalTrials.gov ID
- NCT02907489
- Acronym / sponsor ID
- CEBD-CU-2016-09-194
- Conditions
- Asymptomatic Necrotic Teeth
- Keywords
- post operative pain, triple antibiotic paste, intracanal medication
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Apr 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 20 Sep 2016 (estimated)
- Results
- Posted 24 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether the use of triple antibiotic paste as intracanal medication with an anti-inflammatory drug, compared to a calcium hydroxide will reduce postoperative pain and intracanal bacteria or not in patients with asymptomatic necrotic teeth.
Detailed description
This trial is aiming to answer a clinical question whether in patients with asymptomatic necrotic teeth, the use of triple antibiotic paste as intracanal medication with an anti-inflammatory drug, compared to a calcium hydroxide, reduce postoperative pain and intracanal bacteria or not? trial design will be Randomized, controlled, double blinded, unicenter, parallel, two-arm, superiority trial with 1:1 allocation ratio.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control: Calcium Hydroxide | No intervention | –Non-setting Calcium Hydroxide |
| Test: Triple Antibiotic Paste and Anti-Inflammatory Drug | Other | Other: triple antibiotic paste with an anti-inflammatory drugMixture of ciprofloxacin, metronidazole and minocycline.and diclofenac potassium 50 mg (Catafast) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Subject's age between 18-50 years.
- Both male and female subjects.
- Medically free and healthy subjects.
- Mandibular and maxillary single rooted teeth.
- Asymptomatic non vital teeth.
Key exclusion criteria (7 listed)
- Teeth with acute dentoalveolar abscess.
- Subjects having more than one tooth that require root canal treatment.
- Subjects that have taken analgesic, anti-inflammatory or antibiotic drugs during the 10 days prior to the start of treatment.
- Pregnant females.
- Subjects with systemic diseases who have endocrine diseases, Infectious diseases or Psychological disturbance.
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 with an anti-inflammatory drugMixture of ciprofloxacin, metronidazole and minocycline.and diclofenac potassium 50 mg (Catafast) | Other | Test: Triple Antibiotic Paste and Anti-Inflammatory Drug |
Primary outcome
Post Operative Pain
Time frame: after 24, 48, and 72 hour from the end of the first visit.
Visual Analogue Scale (VAS) of post operative pain (The VAS consisted of a 100 mm horizontal ruler without numbers except a "0" at its first part and a "10" in the last part. With "0" indicating the best outcome while "10" the worst outcome. The subjects were asked to mark the point that was equivalent to their pain intensity. The pain levels were classified as no pain [0], mild pain [1-3], moderate pain [4-7] or severe pain [8-10] )
1 secondary outcome
Intracanal Bacterial Count
Time frame: before and after mechanical preparation (at day 0) and after 72 hour from placement of the intracanal medication.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41552268Omaia M, Negm M, Nashaat Y, Nabil N, Othman A. The effect of triple antibiotic paste as an intracanal medicament with an anti-inflammatory agent on post-operative pain of asymptomatic uniradicular necrotic teeth: a double blind randomized clinical trial. F1000Res. 2025 Dec 16;8:1687. doi: 10.12688/f1000research.19699.3. eCollection 2019.
- Individual participant dataSharing planned: No
Related trials for Asymptomatic Necrotic Teeth
Not yet recruiting
Evaluation of Postoperative Pain and the Antimicrobial Effect of Super Oxidized Water (Microcyn) and Chlorhexidine When Compared With Sodium Hypochlorite in Teeth With Asymptomatic Necrotic Pulps. A Randomized Clinical Trial
Evaluation of Postoperative Pain and Antimicrobial Efficacy
Recruiting
Evaluation of Postoperative Pain and Success Rate Between Lateral Condensation and Warm Vertical Obturation Techniques
Necrotic Pulp, Asymptomatic Apical Periodontitis
Active, not recruitingEarly Phase 1
Antimicrobial Effect of Calcium Silicate and Pectin as Intracanal Medications in Necrotic Teeth With Periapical Lesions
Asymptomatic 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.
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 triple antibiotic paste with an anti-inflammatory drug in people with Asymptomatic Necrotic Teeth, 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 5 inclusion and 7 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 24 Sep 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?
Yes. Results are posted in the registry (first posted 24 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Post Operative Pain (time frame: after 24, 48, and 72 hour from the end of the first visit.). 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 NCT02907489, 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 24 Sep 2019.