Irreversible PulpitisNCT05190406
Success and Quality of Life Following Complete Pulpotomy and Root Canal Treatment
A study testing Pulpotomy and root canal treatment in people with Irreversible Pulpitis, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial summary
The purpose of this study is to compare the Success and quality of life following complete pulpotomy and root canal treatment in teeth with clinical signs indicative of irreversible pulpitis. Read more about this study
- Who is it for?
- Ages 14 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Irreversible Pulpitis
- What is being tested?
- Pulpotomy and root canal treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jun 2021to 1 Aug 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 14 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Mature permanent restorable mandibular molar teeth.
- Tooth should give positive response to pulp sensibility testing.
- Clinical diagnosis of irreversible pulpitis with PAI score≤2.
- Tooth with probing pocket depth and mobility are within normal limits.
- Non-contributory medical history.
Who cannot join
- Teeth with immature roots.
- No pulp exposure after caries excavation.
- Bleeding could not be controlled in 6 minutes.
- Insufficient bleeding after pulp exposure, the pulp is judged necrotic or partially necrotic.
- Absence of antagonist tooth.
- Positive history of antibiotic use in the past 1 month or requiring antibiotic prophylaxis
- Had taken analgesic in past 3 days.
- Tooth with periapical lesion visible on radiograph
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Post graduate institute of dental sciences
Rohtak, Haryana, 124001
About this study
Official title: Success and Quality of Life Following Complete Pulpotomy and Root Canal Treatment in Teeth With Clinical Signs Indicative of Irreversible Pulpitis
The purpose of this study is to compare the Success and quality of life following complete pulpotomy and root canal treatment in teeth with clinical signs indicative of irreversible pulpitis.
Read the detailed description
After thorough history and clinical and radiographic examination, and confirmation of eligibility for the study, risks and benefits associated with the procedure will be explained and written informed consent will be taken from the patients. Study subjects will be randomly allocated to either Complete pulpotomy or Root canal treatment Group.
- Conditions
- Irreversible Pulpitis
- Being tested
- Pulpotomy, root canal treatment
- Keywords
- pulpitis, pulpotomy, single visit root canal treatment, bioceramic material
- Medical subject headings
- Pulpitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PulpotomyProcedure or surgery
After achieving hemostasis, in pulpotomy group bioceramic material will be placed and then permanent restoration will be done.
root canal treatmentProcedure or surgery
Single visit root canal treatment will be done according to standard protocol.
| Study group | Role | What they receive |
|---|---|---|
| Pulpotomy | Experimental | complete pulpotomy will be done till the level of root canal orifice. Receives: Procedure: Pulpotomy |
| Root canal treatment | Active comparator | Single visit root canal treatment will be done according to standard protocol. Receives: Procedure: root canal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical success rate
Clinical success criteria No history of spontaneous pain No tenderness to palpation or percussion Normal mobility and probing pocket depth. Soft tissues around tooth are normal with no swelling or sinus tract.
Measured: 6 months and one year
Radiographic success rate
Radiographic success criteria No pathosis evident on the radiograph Periapical Index score 1 or 2
Measured: 6 months and one year
Secondary outcomes (2)
Oral Health related quality of Life
Oral Health Impact Profile-14 questionnaire of score 0-4 will be used to assess the quality of life. Score 0 means never and 4 means very often affected the quality of life.
Measured: baseline to one week, 6 months and one year
Pain assessment
Visual analogue Scale of 0 to 10 Centimetere line will be used to assess pain. Score 0 means no pain and Score 10 means maximum pain.
Measured: baseline to one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study start1 Jun 2021
- Primary completion31 Jul 2022 (estimated)
- Study completion1 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irreversible PulpitisStudies of the same condition, open and under way.
- More trials run by Postgraduate Institute of Dental Sciences RohtakThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sanjay Tewari, Postgraduate Institute of Dental Sciences Rohtak
- Investigators
- Dr. Sanjay Tewari, MDS, Study director, POST GRADUATE INSTITUTE OF DENTAL SCIENCES, ROHTAK, Haryana, India, 124001
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05190406
- Sponsor's protocol ID
- Kanagadurga
- Status last verified
- Jan 2022
- First submitted
- 10 Dec 2021
- Last updated
- 28 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Success and Quality of Life Following Complete Pulpotomy and Root Canal Treatment in Teeth With Clinical Signs Indicative of Irreversible Pulpitis
- ClinicalTrials.gov ID
- NCT05190406
- Acronym / sponsor ID
- Kanagadurga
- Conditions
- Irreversible Pulpitis
- Keywords
- pulpitis, pulpotomy, single visit root canal treatment, bioceramic material
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 Jul 2022 (estimated)
- Study completion
- 1 Aug 2022 (estimated)
- First posted
- 13 Jan 2022 (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.
The purpose of this study is to compare the Success and quality of life following complete pulpotomy and root canal treatment in teeth with clinical signs indicative of irreversible pulpitis.
Detailed description
After thorough history and clinical and radiographic examination, and confirmation of eligibility for the study, risks and benefits associated with the procedure will be explained and written informed consent will be taken from the patients. Study subjects will be randomly allocated to either Complete pulpotomy or Root canal treatment Group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulpotomy | Experimental | Procedure: Pulpotomycomplete pulpotomy will be done till the level of root canal orifice. |
| Root canal treatment | Active comparator | Procedure: root canal treatmentSingle visit root canal treatment will be done according to standard protocol. |
Who may qualify
- Ages
- 14 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Mature permanent restorable mandibular molar teeth.
- Tooth should give positive response to pulp sensibility testing.
- Clinical diagnosis of irreversible pulpitis with PAI score≤2.
- Tooth with probing pocket depth and mobility are within normal limits.
- Non-contributory medical history.
Key exclusion criteria (8 listed)
- Teeth with immature roots.
- No pulp exposure after caries excavation.
- Bleeding could not be controlled in 6 minutes.
- Insufficient bleeding after pulp exposure, the pulp is judged necrotic or partially necrotic.
- Absence of antagonist tooth.
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 |
|---|---|---|
| PulpotomyAfter achieving hemostasis, in pulpotomy group bioceramic material will be placed and then permanent restoration will be done. | Procedure or surgery | Pulpotomy |
| root canal treatmentSingle visit root canal treatment will be done according to standard protocol. | Procedure or surgery | Root canal treatment |
Primary outcome
Clinical success rate
Time frame: 6 months and one year
Clinical success criteria No history of spontaneous pain No tenderness to palpation or percussion Normal mobility and probing pocket depth. Soft tissues around tooth are normal with no swelling or sinus tract.
Radiographic success rate
Time frame: 6 months and one year
Radiographic success criteria No pathosis evident on the radiograph Periapical Index score 1 or 2
2 secondary outcomes
Oral Health related quality of Life
Time frame: baseline to one week, 6 months and one year
Pain assessment
Time frame: baseline to one week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2022.
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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.
Dr. Sanjay Tewari, MDS study director
POST GRADUATE INSTITUTE OF DENTAL SCIENCES, ROHTAK, Haryana, India, 124001
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulpotomy and root canal treatment in people with Irreversible Pulpitis, run by Postgraduate Institute of Dental Sciences Rohtak 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 5 inclusion and 8 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 28 Jan 2022. 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?
Contact DR. Pankaj Sangwan, MDS (9996112202, drps_1@yahoo.co.in), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical success rate (time frame: 6 months and one year). The study lists 2 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 28 Jan 2022.