Symptomatic Periapical PeriodontitisNCT03033147
Effect of Preoperative Amoxicillin/Clavulanic Acid Combination on Postoperative Endodontic Pain
A study testing Amoxicillin/Clavulanate Potassium 875 mg-125 mg oral tablet in people with Symptomatic Periapical Periodontitis, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this prospective, randomized, placebo controlled study is to evaluate the effect of a single preoperative dose of amoxicillin/clavulanic acid combination 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?
- Amoxicillin/Clavulanate Potassium 875 mg-125 mg oral tablet
- 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
- 1 siteEgypt
- Study dates
- 18 Oct 2019to 15 Mar 2020
- Phase
- Interventional
- 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 who do not have evidence of spreading infection or systemic involvement.
- Mandibular posterior teeth.
- Patients with non-contributory systemic condition.
- Patients who can understand pain scales and able to sign informed consent.
Who cannot join
- Patients allergic to penicillin.
- Patients who have a draining sinus tract.
- Retreatment cases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Preoperative, Single-dose Amoxicillin/Clavulanic Acid Combination on Postoperative Endodontic Pain in Patients With Symptomatic Apical Periodontitis: A Double-Blind Randomized Controlled Trial.
The aim of this prospective, randomized, placebo controlled study is to evaluate the effect of a single preoperative dose of amoxicillin/clavulanic acid combination 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.
Prior to initiation of root canal treatment, eligible participants will be randomly assigned to one of the following groups: experimental group (receiving 2 gm of amoxicillin/ clavulanic acid orally 30 minutes before the treatment) or control group (receiving a placebo 30 minutes before treatment).
Root canal treatment will then be carried out in a single visit.
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
- Amoxicillin/Clavulanate Potassium 875 mg-125 mg oral tablet, Oral placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amoxicillin/Clavulanate Potassium 875 mg-125 mg oral tabletDrug
Also called Augmentin
2 gm of amoxicillin/ clavulanic acid combination orally 30 minutes before root canal treatment
Oral placeboDrug
placebo 30 minutes before root canal treatment
| Study group | Role | What they receive |
|---|---|---|
| Amoxicillin/Clavulanate Potassium | Experimental | Amoxicillin/Clavulanate Potassium 875 mg-125 mg orally 30 minutes before root canal treatment Receives: Drug: Amoxicillin/Clavulanate Potassium 875 mg-125 mg oral tablet |
| Placebo | Placebo comparator | placebo 30 minutes before root canal treatment Receives: Drug: Oral placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
Postoperative 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: Up to 7 days after endodontic treatment
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)
- Study start18 Oct 2019
- Primary completion15 Mar 2020
- Study completion15 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nermeen Naser Taleb Moushtaha, Cairo University
- Investigators
- Nermeen NT Moushtaha, Postgraduate, Principal investigator, Cairo UniversitySuzan AW Amin, PhD, Study chair, Cairo UniversityShaimaa Gawdat, PhD, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03033147
- Sponsor's protocol ID
- CEBC-CU-2016-12-163
- Status last verified
- Jun 2021
- First submitted
- 24 Jan 2017
- Last updated
- 18 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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 24967571Akbar I. Efficacy of Prophylactic use of Antibiotics to Avoid Flare up During Root Canal Treatment of Nonvital Teeth: A Randomized Clinical Trial. J Clin Diagn Res. 2015 Mar;9(3):ZC08-11. doi: 10.7860/JCDR/2015/12046.5620. Epub 2015 Mar 1.
PubMed 25954695Contardo L, Meneguzzi E, Cadenaro M, Di Lenarda R. Clinical evaluation of antibiotic prophylaxis before endodontic treatment of necrotic teeth. Minerva Stomatol. 2005 Mar;54(3):153-60. English, Italian.
PubMed 15920447Pickenpaugh L, Reader A, Beck M, Meyers WJ, Peterson LJ. Effect of prophylactic amoxicillin on endodontic flare-up in asymptomatic, necrotic teeth. J Endod. 2001 Jan;27(1):53-6. doi: 10.1097/00004770-200101000-00019.
PubMed 11487166
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preoperative, Single-dose Amoxicillin/Clavulanic Acid Combination on Postoperative Endodontic Pain in Patients With Symptomatic Apical Periodontitis: A Double-Blind Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT03033147
- Acronym / sponsor ID
- CEBC-CU-2016-12-163
- Conditions
- Symptomatic Periapical Periodontitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 18 Oct 2019 (actual)
- Primary completion
- 15 Mar 2020 (actual)
- Study completion
- 15 Mar 2020 (actual)
- 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 a single preoperative dose of amoxicillin/clavulanic acid combination 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.
Prior to initiation of root canal treatment, eligible participants will be randomly assigned to one of the following groups: experimental group (receiving 2 gm of amoxicillin/ clavulanic acid orally 30 minutes before the treatment) or control group (receiving a placebo 30 minutes before treatment).
Root canal treatment will then be carried out in a single visit.
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 |
|---|---|---|
| Amoxicillin/Clavulanate Potassium | Experimental | Drug: Amoxicillin/Clavulanate Potassium 875 mg-125 mg oral tabletAmoxicillin/Clavulanate Potassium 875 mg-125 mg orally 30 minutes before root canal treatment |
| Placebo | Placebo comparator | Drug: Oral placeboplacebo 30 minutes before root canal treatment |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients with symptomatic apical periodontitis who do not have evidence of spreading infection or systemic involvement.
- Mandibular posterior teeth.
- Patients with non-contributory systemic condition.
- Patients who can understand pain scales and able to sign informed consent.
Key exclusion criteria (3 listed)
- Patients allergic to penicillin.
- Patients who have a draining sinus tract.
- Retreatment cases.
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 |
|---|---|---|
| Amoxicillin/Clavulanate Potassium 875 mg-125 mg oral tabletAlso: Augmentin2 gm of amoxicillin/ clavulanic acid combination orally 30 minutes before root canal treatment | Drug | Amoxicillin/Clavulanate Potassium |
| Oral placeboplacebo 30 minutes before root canal treatment | Drug | Placebo |
Primary outcome
Postoperative pain
Time frame: Up to 7 days after endodontic treatment
Postoperative pain will be measured by a numerical rating scale (NRS).
1 secondary outcome
Swelling
Time frame: Up to 7 days after endodontic treatment
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 18 Jun 2021.
- Background: 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.
- Background: PubMed 25954695Akbar I. Efficacy of Prophylactic use of Antibiotics to Avoid Flare up During Root Canal Treatment of Nonvital Teeth: A Randomized Clinical Trial. J Clin Diagn Res. 2015 Mar;9(3):ZC08-11. doi: 10.7860/JCDR/2015/12046.5620. Epub 2015 Mar 1.
- Background: PubMed 15920447Contardo L, Meneguzzi E, Cadenaro M, Di Lenarda R. Clinical evaluation of antibiotic prophylaxis before endodontic treatment of necrotic teeth. Minerva Stomatol. 2005 Mar;54(3):153-60. English, Italian.
- Background: PubMed 11487166Pickenpaugh L, Reader A, Beck M, Meyers WJ, Peterson LJ. Effect of prophylactic amoxicillin on endodontic flare-up in asymptomatic, necrotic teeth. J Endod. 2001 Jan;27(1):53-6. doi: 10.1097/00004770-200101000-00019.
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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 NT Moushtaha, Postgraduate principal investigator
Cairo University
Suzan AW Amin, PhD study chair
Cairo University
Shaimaa Gawdat, PhD study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amoxicillin/Clavulanate Potassium 875 mg-125 mg oral tablet in people with Symptomatic Periapical Periodontitis, run by Cairo University 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 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: finished, as of the sponsor's last update on 18 Jun 2021. 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. 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.
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: 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 NCT03033147, which also lists 4 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 18 Jun 2021.