Root Canal InfectionPhase 1NCT04250519
Evaluation of Post Operative Pain in Retreatment of Molars Using Different Irrigant
A Phase 1 study testing Sodium Hypochlorite in people with Root Canal Infection, run by Tamil Nadu Dr.M.G.R.Medical University at 1 site in India.
Trial summary
This study evaluates the efficacy of dexamethasone as a intracanal irrigant along with sodium hypochlorite 1% and 5.25% concentrations in post treatment pain for molar root canal retreatment. Read more about this study
- Who is it for?
- Ages 15 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Root Canal Infection
- What is being tested?
- Sodium Hypochlorite
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteIndia
- Study dates
- 3 Feb 2020to 15 Apr 2021
- 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 15 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- teeth previously treated or attempted root canal treatment,
- teeth with or without symptoms,
- periapical radiograph showing evidence of inadequate previous root canal treatment or periapical changes,
- only teeth or at least one canal where complete removal of root canal filling material was possible and reach the working length in first appointment.
Who cannot join
- patient not willing for follow up,
- teeth with extensive cervical or apical resorption that restricted the use of sodium hypochlorite irrigation,
- teeth with poor periodontal status, teeth not suitable for post endodontic restoration,
- patients with acute periapical abscess,
- patients with systemic conditions preventing radiograph exposure or multi visit treatment,
- pregnant patients,
- patients with allergy to any known dental materials.
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
Anand Sherwood, 9791443950, anand.sherwood@gmail.com
Valliappan C.T, post graduate
About this study
Official title: Assessment of Post Operative Pain Following Root Canal Retreatment in Molars Using Four Different Combination of Irrigants : A Prospective Clinical Study
This study evaluates the efficacy of dexamethasone as a intracanal irrigant along with sodium hypochlorite 1% and 5.25% concentrations in post treatment pain for molar root canal retreatment.
Read the detailed description
Main objective of root canal retreatment is to alleviate pain and disinfect the rootcanal .However some patients may experience mild to severe pain following treatment , which leads to intake of painkillers orally for post operative pain management.
So , this study evaluates the efficiency of dexamethasone used as intracanal irrigant in post treatment pain for molar root canal retreatment sodium hypochlorite (1% \&5.25%) is used for disinfecting the canals patients will be grouped into Symptomatic and Asymptomatic patients requiring root canal retreatment and irrigants will be used in various combinations as mentioned below
- 1% sodium hypochlorite alone 2.5ml in each canal along with ultrasonic activation
- 1% sodium hypochlorite and dexamethasone 4mg,2.5ml in each canal along with ultrasonic activation
- 5.25% sodium hypochlorite alone 2.5ml in each canal along with ultrasonic activation
- 5.25% sodium hypochlorite and dexamethasone 4mg, 2.5ml in each canal along with ultrasonic activation calcium hydroxide is commonly used as intracanal medicament in all the patients post operative symptoms is evaluated at 12 hrs , 24 hrs,48 hrs, 72 hrs and 1 week followed by obturation is completed
- Conditions
- Root Canal Infection
- Being tested
- Sodium Hypochlorite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium HypochloriteDrug
Sodium hypochlorite is used as intracanal irrigant to minimize the post operative pain
| Study group | Role | What they receive |
|---|---|---|
| 1% sodium hypochlorite & dexamethasone 4mg as irrigants | Experimental | sodium hypochlorite is effective in any concentration as antimicrobial irrigant and dexamethasone is anti inflammatory drug Receives: Drug: Sodium Hypochlorite |
| 1% sodium hypochlorite as irrigant &normal saline as placebo | Active comparator | sodium hypochlorite is effective in any concentration as irrigant Receives: Drug: Sodium Hypochlorite |
| 5.25% sodium hypochlorite and dexamethasone 4mg as irrigants | Experimental | sodium hypochlorite is effective in any concentration as antimicrobial irrigant and dexamethasone is anti inflammatory drug Receives: Drug: Sodium Hypochlorite |
| 5.25% sodium hypochlorite &normal saline as placebo | Active comparator | sodium hypochlorite is effective in any concentration as irrigant Receives: Drug: Sodium Hypochlorite |
What is being measured
The primary outcome is the main question the study is designed to answer.
post operative pain evaluation using various combination of irrigants: VAS score
pain scale is evaluated using VISUAL ANALOG SCALE (VAS) score (1-10) 1 is minimum amount of pain experienced and 10 is maximum amount of pain experienced [1-3] mild pain , [4-7] moderate pain , [8-10] severe pain .
Measured: At 6 hours
post operative pain evaluation using various combination of irrigants: VAS score
pain scale is evaluated using VISUAL ANALOG SCALE (VAS) score (1-10) 1 is minimum amount of pain experienced and 10 is maximum amount of pain experienced [1-3] mild pain , [4-7] moderate pain , [8-10] severe pain .
Measured: At 12 hours
post operative pain evaluation using various combination of irrigants: VAS score
pain scale is evaluated using VISUAL ANALOG SCALE (VAS) score (1-10) 1 is minimum amount of pain experienced and 10 is maximum amount of pain experienced [1-3] mild pain , [4-7] moderate pain , [8-10] severe pain .
Measured: At 24 hours
post operative pain evaluation using various combination of irrigants: VAS score
pain scale is evaluated using VISUAL ANALOG SCALE (VAS) score (1-10) 1 is minimum amount of pain experienced and 10 is maximum amount of pain experienced [1-3] mild pain , [4-7] moderate pain , [8-10] severe pain .
Measured: At 48 hours
post operative pain evaluation using various combination of irrigants: VAS score
pain scale is evaluated using VISUAL ANALOG SCALE (VAS) score (1-10) 1 is minimum amount of pain experienced and 10 is maximum amount of pain experienced [1-3] mild pain , [4-7] moderate pain , [8-10] severe pain .
Measured: At 72 hours
post operative pain evaluation using various combination of irrigants: VAS score
pain scale is evaluated using VISUAL ANALOG SCALE (VAS) score (1-10) 1 is minimum amount of pain experienced and 10 is maximum amount of pain experienced [1-3] mild pain , [4-7] moderate pain , [8-10] severe pain .
Measured: After 7 days
Secondary outcomes (3)
assessment of other variables in pain scale
comparing the pain scale experienced between male and female in VAS score
Measured: through study completion, an average of 1 week
assessment of other variables in pain scale
comparing the pain scale experienced between mandibular molar and maxillary molar from VAS score
Measured: through study completion, an average of 1 week
assessment of other variables in pain scale
comparing the pain scale based on patients pre operative symptom ex; patient is symptomatic or Asymptomatic before treatment procedure
Measured: through study completion, an average of 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2020
- Study start3 Feb 2020
- Primary completion15 Feb 2021 (estimated)
- Study completion15 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Root Canal InfectionStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tamil Nadu Dr.M.G.R.Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. CT. VALLIAPPAN, Tamil Nadu Dr.M.G.R.Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04250519
- Sponsor's protocol ID
- TamilNaduMU
- Status last verified
- May 2020
- First submitted
- 22 Jan 2020
- Last updated
- 7 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Post Operative Pain Following Root Canal Retreatment in Molars Using Four Different Combination of Irrigants : A Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT04250519
- Acronym / sponsor ID
- TamilNaduMU
- Conditions
- Root Canal Infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Tamil Nadu Dr.M.G.R.Medical UniversityUniversity, hospital or other
- Study start
- 3 Feb 2020 (actual)
- Primary completion
- 15 Feb 2021 (estimated)
- Study completion
- 15 Apr 2021 (estimated)
- First posted
- 31 Jan 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.
This study evaluates the efficacy of dexamethasone as a intracanal irrigant along with sodium hypochlorite 1% and 5.25% concentrations in post treatment pain for molar root canal retreatment.
Detailed description
Main objective of root canal retreatment is to alleviate pain and disinfect the rootcanal .However some patients may experience mild to severe pain following treatment , which leads to intake of painkillers orally for post operative pain management.
So , this study evaluates the efficiency of dexamethasone used as intracanal irrigant in post treatment pain for molar root canal retreatment sodium hypochlorite (1% \&5.25%) is used for disinfecting the canals patients will be grouped into Symptomatic and Asymptomatic patients requiring root canal retreatment and irrigants will be used in various combinations as mentioned below
- 1% sodium hypochlorite alone 2.5ml in each canal along with ultrasonic activation
- 1% sodium hypochlorite and dexamethasone 4mg,2.5ml in each canal along with ultrasonic activation
- 5.25% sodium hypochlorite alone 2.5ml in each canal along with ultrasonic activation
- 5.25% sodium hypochlorite and dexamethasone 4mg, 2.5ml in each canal along with ultrasonic activation calcium hydroxide is commonly used as intracanal medicament in all the patients post operative symptoms is evaluated at 12 hrs , 24 hrs,48 hrs, 72 hrs and 1 week followed by obturation is completed
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1% sodium hypochlorite & dexamethasone 4mg as irrigants | Experimental | Drug: Sodium Hypochloritesodium hypochlorite is effective in any concentration as antimicrobial irrigant and dexamethasone is anti inflammatory drug |
| 1% sodium hypochlorite as irrigant &normal saline as placebo | Active comparator | Drug: Sodium Hypochloritesodium hypochlorite is effective in any concentration as irrigant |
| 5.25% sodium hypochlorite and dexamethasone 4mg as irrigants | Experimental | Drug: Sodium Hypochloritesodium hypochlorite is effective in any concentration as antimicrobial irrigant and dexamethasone is anti inflammatory drug |
| 5.25% sodium hypochlorite &normal saline as placebo | Active comparator | Drug: Sodium Hypochloritesodium hypochlorite is effective in any concentration as irrigant |
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- teeth previously treated or attempted root canal treatment,
- teeth with or without symptoms,
- periapical radiograph showing evidence of inadequate previous root canal treatment or periapical changes,
- only teeth or at least one canal where complete removal of root canal filling material was possible and reach the working length in first appointment.
Key exclusion criteria (7 listed)
- patient not willing for follow up,
- teeth with extensive cervical or apical resorption that restricted the use of sodium hypochlorite irrigation,
- teeth with poor periodontal status, teeth not suitable for post endodontic restoration,
- patients with acute periapical abscess,
- patients with systemic conditions preventing radiograph exposure or multi visit treatment,
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 |
|---|---|---|
| Sodium HypochloriteSodium hypochlorite is used as intracanal irrigant to minimize the post operative pain | Drug | 1% sodium hypochlorite & dexamethasone 4mg as irrigants, 1% sodium hypochlorite as irrigant &normal saline as placebo, 5.25% sodium hypochlorite &normal saline as placebo, 5.25% sodium hypochlorite and dexamethasone 4mg as irrigants |
Primary outcome
post operative pain evaluation using various combination of irrigants: VAS score
Time frame: At 6 hours
pain scale is evaluated using VISUAL ANALOG SCALE (VAS) score (1-10) 1 is minimum amount of pain experienced and 10 is maximum amount of pain experienced [1-3] mild pain , [4-7] moderate pain , [8-10] severe pain .
post operative pain evaluation using various combination of irrigants: VAS score
Time frame: At 12 hours
pain scale is evaluated using VISUAL ANALOG SCALE (VAS) score (1-10) 1 is minimum amount of pain experienced and 10 is maximum amount of pain experienced [1-3] mild pain , [4-7] moderate pain , [8-10] severe pain .
post operative pain evaluation using various combination of irrigants: VAS score
Time frame: At 24 hours
pain scale is evaluated using VISUAL ANALOG SCALE (VAS) score (1-10) 1 is minimum amount of pain experienced and 10 is maximum amount of pain experienced [1-3] mild pain , [4-7] moderate pain , [8-10] severe pain .
post operative pain evaluation using various combination of irrigants: VAS score
Time frame: At 48 hours
pain scale is evaluated using VISUAL ANALOG SCALE (VAS) score (1-10) 1 is minimum amount of pain experienced and 10 is maximum amount of pain experienced [1-3] mild pain , [4-7] moderate pain , [8-10] severe pain .
post operative pain evaluation using various combination of irrigants: VAS score
Time frame: At 72 hours
pain scale is evaluated using VISUAL ANALOG SCALE (VAS) score (1-10) 1 is minimum amount of pain experienced and 10 is maximum amount of pain experienced [1-3] mild pain , [4-7] moderate pain , [8-10] severe pain .
post operative pain evaluation using various combination of irrigants: VAS score
Time frame: After 7 days
pain scale is evaluated using VISUAL ANALOG SCALE (VAS) score (1-10) 1 is minimum amount of pain experienced and 10 is maximum amount of pain experienced [1-3] mild pain , [4-7] moderate pain , [8-10] severe pain .
3 secondary outcomes
assessment of other variables in pain scale
Time frame: through study completion, an average of 1 week
assessment of other variables in pain scale
Time frame: through study completion, an average of 1 week
assessment of other variables in pain scale
Time frame: through study completion, an average of 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2020.
- Individual participant dataSharing planned: Yes
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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 Phase 1 study testing Sodium Hypochlorite in people with Root Canal Infection, run by Tamil Nadu Dr.M.G.R.Medical University 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 4 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: status not confirmed, as of the sponsor's last update on 7 May 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Valliappan C.T, post graduate (MDS) (8870558925 ext. 8248785715, vrvalliappan2@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post operative pain evaluation using various combination of irrigants: VAS score (time frame: At 6 hours). The study lists 6 primary outcomes in all. 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 7 May 2020.