Symptomatic Periapical PeriodontitisPhase 2/3NCT03033472
Effect of Preoperative Clindamycin on Postoperative Endodontic Pain
A Phase 2/3 study testing 600 mg Clindamycin orally in people with Symptomatic Periapical Periodontitis, run by Cairo University.
Trial summary
The aim of this prospective, randomized, placebo controlled study is to evaluate the effect of clindamycin on post-operative pain and swelling in adult patient with symptomatic apical periodontitis. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Symptomatic Periapical Periodontitis
- What is being tested?
- 600 mg Clindamycin orally
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- Start not givento Dec 2017
- Phase
- Phase 2/3
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with symptomatic apical periodontitis and do not have evidence of spreading infection or systemic involvement.
- Mandibular posterior teeth.
- Patients in good health.
- Patients who can understand pain scales (NRS).
- Patients able to sign informed consent.
Who cannot join
- Patients who have draining sinus tract.
- Retreatment cases
- Patients with weeping canals.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Preoperative Single-dose Clindamycin on Postoperative Endodontic Pain in Patients With Symptomatic Apical Periodontitis: A Randomized Controlled Trial
The aim of this prospective, randomized, placebo controlled study is to evaluate the effect of clindamycin on post-operative pain and swelling in adult patient with symptomatic apical periodontitis.
Read the detailed description
Medical and dental history will be obtained from all patients participating in this trial. Clinical and radiographic evaluation for each tooth included in this study will be recorded.
Clinical diagnosis of symptomatic apical periodontitis is to be confirmed.
Before root canal treatment, eligible participants will be randomly assigned to one of the following groups: experimental group (taking 600 mg of clindamycin orally) or control group (taking placebo ) 30 minutes before the start of the treatment. Single-visit root canal treatment will be performed.
Each patient will receive a 7-day diary to record postoperative pain and swelling.In case of pain, the participant will be instructed to take an analgesic. Post-operative pain will be measured as a primary outcome on 11-point scale (NRS) at the following time points: 6, 12, 24, 48, 72 hours and 7 days. The occurrence of swelling will be reported by participant as a secondary outcome
- Conditions
- Symptomatic Periapical Periodontitis
- Being tested
- 600 mg Clindamycin orally, Oral Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
600 mg Clindamycin orallyDrug
600 mg Clindamycin orally 30 minutes before treatment
Oral PlaceboDrug
Oral Placebo 30 minutes before treatment
| Study group | Role | What they receive |
|---|---|---|
| Clindamycin | Experimental | 600 mg of Clindamycin orally 30 minutes before root canal treatment Receives: Drug: 600 mg Clindamycin orally |
| Placebo | Placebo comparator | placebo 30 minutes Orally before treatment Receives: Drug: Oral Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative pain
Post-operative pain will be measured by a numerical rating scale (NRS)
Measured: Up to 7 days after endodontic treatment
Secondary outcomes (1)
Swelling
The occurrence of Swelling will be measured by a questionnaire
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2017 (estimated)
- Primary completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Symptomatic 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nermeen Saeed Abdel Ghany El Sedawy, Cairo University
- Investigators
- Nermeen SA El Sedawy, Post Graduate, Principal investigator, Cairo UniversitySuzan AW Wanees, PhD, Study chair, Cairo UnivertsityShaimaa Gawdat, PhD, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03033472
- Sponsor's protocol ID
- CEBC-CU-2017-01-09
- Status last verified
- Jan 2017
- First submitted
- 24 Jan 2017
- Last updated
- 27 Jan 2017
- Results posted
- No
Publications
Cope A, Francis N, Wood F, Mann MK, Chestnutt IG. Systemic antibiotics for symptomatic apical periodontitis and acute apical abscess in adults. Cochrane Database Syst Rev. 2014 Jun 26;(6):CD010136. doi: 10.1002/14651858.CD010136.pub2.
PubMed 24967571Lindeboom JA, Frenken JW, Valkenburg P, van den Akker HP. The role of preoperative prophylactic antibiotic administration in periapical endodontic surgery: a randomized, prospective double-blind placebo-controlled study. Int Endod J. 2005 Dec;38(12):877-81. doi: 10.1111/j.1365-2591.2005.01030.x.
PubMed 16343114
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preoperative Single-dose Clindamycin on Postoperative Endodontic Pain in Patients With Symptomatic Apical Periodontitis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03033472
- Acronym / sponsor ID
- CEBC-CU-2017-01-09
- Conditions
- Symptomatic Periapical Periodontitis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Primary completion
- Dec 2017 (estimated)
- First posted
- 26 Jan 2017 (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.
The aim of this prospective, randomized, placebo controlled study is to evaluate the effect of clindamycin on post-operative pain and swelling in adult patient with symptomatic apical periodontitis.
Detailed description
Medical and dental history will be obtained from all patients participating in this trial. Clinical and radiographic evaluation for each tooth included in this study will be recorded.
Clinical diagnosis of symptomatic apical periodontitis is to be confirmed.
Before root canal treatment, eligible participants will be randomly assigned to one of the following groups: experimental group (taking 600 mg of clindamycin orally) or control group (taking placebo ) 30 minutes before the start of the treatment. Single-visit root canal treatment will be performed.
Each patient will receive a 7-day diary to record postoperative pain and swelling.In case of pain, the participant will be instructed to take an analgesic. Post-operative pain will be measured as a primary outcome on 11-point scale (NRS) at the following time points: 6, 12, 24, 48, 72 hours and 7 days. The occurrence of swelling will be reported by participant as a secondary outcome
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clindamycin | Experimental | Drug: 600 mg Clindamycin orally600 mg of Clindamycin orally 30 minutes before root canal treatment |
| Placebo | Placebo comparator | Drug: Oral Placeboplacebo 30 minutes Orally before treatment |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients with symptomatic apical periodontitis and do not have evidence of spreading infection or systemic involvement.
- Mandibular posterior teeth.
- Patients in good health.
- Patients who can understand pain scales (NRS).
- Patients able to sign informed consent.
Key exclusion criteria (3 listed)
- Patients who have draining sinus tract.
- Retreatment cases
- Patients with weeping canals.
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 |
|---|---|---|
| 600 mg Clindamycin orally600 mg Clindamycin orally 30 minutes before treatment | Drug | Clindamycin |
| Oral PlaceboOral Placebo 30 minutes before treatment | Drug | Placebo |
Primary outcome
Post-operative pain
Time frame: Up to 7 days after endodontic treatment
Post-operative pain will be measured by a numerical rating scale (NRS)
1 secondary outcome
Swelling
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2017.
- Results publication: PubMed 24967571Cope A, Francis N, Wood F, Mann MK, Chestnutt IG. Systemic antibiotics for symptomatic apical periodontitis and acute apical abscess in adults. Cochrane Database Syst Rev. 2014 Jun 26;(6):CD010136. doi: 10.1002/14651858.CD010136.pub2.
- Results publication: PubMed 16343114Lindeboom JA, Frenken JW, Valkenburg P, van den Akker HP. The role of preoperative prophylactic antibiotic administration in periapical endodontic surgery: a randomized, prospective double-blind placebo-controlled study. Int Endod J. 2005 Dec;38(12):877-81. doi: 10.1111/j.1365-2591.2005.01030.x.
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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.
Nermeen SA El Sedawy, Post Graduate principal investigator
Cairo University
Suzan AW Wanees, PhD study chair
Cairo Univertsity
Shaimaa Gawdat, PhD study director
Cairo University
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing 600 mg Clindamycin orally in people with Symptomatic 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 5 inclusion and 3 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 27 Jan 2017. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nermeen SA El Sedawy, Post Graduate (01002463414, nermeen.elsedaway@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative pain (time frame: Up to 7 days after endodontic treatment). 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 NCT03033472, which also lists 2 linked publications.
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 27 Jan 2017.