Dentoalveolar AbscessNCT04684407
C-reactive Protein Levels in Acute Apical Abscess Due to Root Canal Infection
A study testing ROOT CANAL TREATMENT in people with Dentoalveolar Abscess, run by CSI College of Dental Sciences and Research, Madurai at 1 site in India.
Trial summary
C-reactive protein levels of patients with acute apical abscess are evaluated before and after root canal treatment Read more about this study
- Who is it for?
- Ages 16 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Dentoalveolar Abscess
- What is being tested?
- ROOT CANAL TREATMENT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIndia
- Study dates
- 1 Nov 2020to 1 Dec 2022
- 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 16 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- patient with acute apical abscess
Who cannot join
- Teeth with evidence of previous initiated root canal treatment
- History of myocardial infarction, coronary heart disease
- Patients allergic to local anesthetic
- Patients under steroid medication
- Patients who are immunocompromised
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Csi College of Dental Sciences and Research
Madurai, Tamil Nadu, 625001
JOYSON JOE ASIR J, MDS III YR, 09488986939, joysonjoe10@gmail.com
About this study
Official title: Assessment of C-reactive Protein Levels in Acute Apical Abscess Due to Root Canal Infection
C-reactive protein levels of patients with acute apical abscess are evaluated before and after root canal treatment
Read the detailed description
In patients with acute apical abscess C-reactive proteins are evaluated before and after root canal treatment. In this intra-canal medications calcium hydroxide and triple antibiotic paste are compared. PAI score of the corresponding tooth is noted .
- Conditions
- Dentoalveolar Abscess
- Being tested
- ROOT CANAL TREATMENT
- Medical subject headings
- Periapical Abscess
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ROOT CANAL TREATMENTProcedure or surgery
TWO TYPE OF INTRA CANAL MEDICATION PLACEMENT
| Study group | Role | What they receive |
|---|---|---|
| calcium hydroxide | Active comparator | calcium hydroxide powder is mixed with normal saline and placed as intra-canal medication Receives: Procedure: ROOT CANAL TREATMENT |
| Triple antibiotic paste | Experimental | Triple antibiotic paste (TAP)- combination of metronidazole,ciprofloxacin and minocycline mixed in a ratio of 1:1:1 .
TAP paste is combined with propylene glycol and placed as intra canal medication. Receives: Procedure: ROOT CANAL TREATMENT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post root canal C reactive protein level
Pre-operative serum c-reactive protein level was measured to which the post operative c-reactive protein level after 2 weeks of root canal treatment are compared.
The normal serum c-reactive protein level is 0 - 6.00 mg/L.
Measured: 2 weeks
Secondary outcomes (1)
pain and swelling assessment
pain and swelling reduction after root canal treatment is assessed. . Pain is evaluated using visual analgue scale (VAS) , regarding swellling reduction patient is asked to evaluate subjectively whether the patient profile has returned to normal after the treatment and they were asked how many days it took for the swelling to resolve completely.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study start1 Nov 2020
- Primary completion1 Jul 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dentoalveolar AbscessStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSI College of Dental Sciences and Research, Madurai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr.Joyson Joe Asir.J, CSI College of Dental Sciences and Research, Madurai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04684407
- Sponsor's protocol ID
- CSIDentalCMadurai
- Status last verified
- Dec 2020
- First submitted
- 15 Dec 2020
- Last updated
- 24 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of C-reactive Protein Levels in Acute Apical Abscess Due to Root Canal Infection
- ClinicalTrials.gov ID
- NCT04684407
- Acronym / sponsor ID
- CSIDentalCMadurai
- Conditions
- Dentoalveolar Abscess
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- CSI College of Dental Sciences and Research, MaduraiUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 24 Dec 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.
C-reactive protein levels of patients with acute apical abscess are evaluated before and after root canal treatment
Detailed description
In patients with acute apical abscess C-reactive proteins are evaluated before and after root canal treatment. In this intra-canal medications calcium hydroxide and triple antibiotic paste are compared. PAI score of the corresponding tooth is noted .
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| calcium hydroxide | Active comparator | Procedure: ROOT CANAL TREATMENTcalcium hydroxide powder is mixed with normal saline and placed as intra-canal medication |
| Triple antibiotic paste | Experimental | Procedure: ROOT CANAL TREATMENTTriple antibiotic paste (TAP)- combination of metronidazole,ciprofloxacin and minocycline mixed in a ratio of 1:1:1 . TAP paste is combined with propylene glycol and placed as intra canal medication. |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patient with acute apical abscess
Key exclusion criteria (5 listed)
- Teeth with evidence of previous initiated root canal treatment
- History of myocardial infarction, coronary heart disease
- Patients allergic to local anesthetic
- Patients under steroid medication
- Patients who are immunocompromised
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 |
|---|---|---|
| ROOT CANAL TREATMENTTWO TYPE OF INTRA CANAL MEDICATION PLACEMENT | Procedure or surgery | Triple antibiotic paste, calcium hydroxide |
Primary outcome
Post root canal C reactive protein level
Time frame: 2 weeks
Pre-operative serum c-reactive protein level was measured to which the post operative c-reactive protein level after 2 weeks of root canal treatment are compared. The normal serum c-reactive protein level is 0 - 6.00 mg/L.
1 secondary outcome
pain and swelling assessment
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2020.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ROOT CANAL TREATMENT in people with Dentoalveolar Abscess, run by CSI College of Dental Sciences and Research, Madurai at 1 site in India.
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 1 inclusion and 5 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 24 Dec 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 India. 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post root canal C reactive protein level (time frame: 2 weeks). 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 24 Dec 2020.