Irreversible PulpitisNCT06768567
Evaluation of Hemostasis Time on Partial Pulpotomy in Teeth With Clinical Signs Indicative of Irreversible Pulpitis
A study testing effect of hemostasis time on outcome of partial pulpotomy in teeth with clinical signs indicative of irreversible pulpitis. in people with Irreversible Pulpitis and Partial Pulpotomy, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial summary
The aim of this prospective study is to investigate the influence of time taken to achieve hemostasis on outcome of partial pulpotomy in teeth with clinical signs indicative of irreversible pulpitis. OBJECTIVE:- 1. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Irreversible Pulpitis, Partial Pulpotomy
- What is being tested?
- effect of hemostasis time on outcome of partial pulpotomy in teeth with clinical signs indicative of irreversible pulpitis.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jun 2023to 31 Jan 2025
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Mature permanent mandibular molars with carious pulp exposures and signs suggestive of irreversible pulpitis.
- vital pulp with demonstrable bleeding upon entry.
- The tooth is restorable.
- Tooth with mobility and probing depth within normal limits.
- Soft tissues around the tooth are normal with no swelling or sinus tract.
- No evidence of chronic apical periodontitis (PAI 1,2)
Who cannot join
- patients who report history of antibiotic intake in past 1 month or analgesic intake in past 3 days.
- pregnant women.
- absence of opposing teeth
- 3rd molars
- medically compromised patients .
- Tenderness on percussion positive
- pathologic mobility
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Effect of Hemostasis Time on Partial Pulpotomy in Mature Permanent Teeth With Clinical Signs Indicative of Irreversible Pulpitis
The aim of this prospective study is to investigate the influence of time taken to achieve hemostasis on outcome of partial pulpotomy in teeth with clinical signs indicative of irreversible pulpitis.
OBJECTIVE:-
Read more
- To evaluate clinical and radiographic success of time taken to achieve hemostasis on outcome of partial pulpotomy in mature permanent teeth with clinical signs indicative of irreversible pulpitis.
- To evaluate OHRQoL and pain incidence \& severity after partial pulpotomy in teeth with clinical signs indicative of irreversible pulpitis.
Participants will of age group 18 to 45 years will be included and divided into two groups based on hemostasis time:
I(Intervention) - 6minutes C (Comparison) - 7-12 minutes
Read the detailed description
TITLE:- Evaluation of hemostasis time on partial pulpotomy in teeth with clinical signs indicative of irreversible pulpitis.
P (Population) - Mature permanent molars with clinical signs of irreversible pulpitis.
I (Intervention) - 6minutes C (Comparison) - 7-12 minutes O (Outcome) - Assessment of clinical and radiographic success at 12 months of follow up .
Assessment of OHRQoL at baseline, post-operatively every 24 hours for 1 week \& incidence and severity of pain at baseline and post-operatively every 24 hours till 1 week.
Time taken to achieve hemostasis has been suggested as a reliable surrogate measure to determine the depth of inflammation in the pulp. In absence of any other intraoperative indicator, it serves as a useful guide to the extent of pulp tissue removal required during pulpotomy. This trial will help formulate evidence based guideline regarding time for hemostasis advisable to achieve optimum success during pulpotomy in teeth with signs indicative of irreversible pulpitis.
- Conditions
- Irreversible Pulpitis, Partial Pulpotomy
- Being tested
- effect of hemostasis time on outcome of partial pulpotomy in teeth with clinical signs indicative of irreversible pulpitis.
- Keywords
- partial pulpotomy, hemostatsis time
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
effect of hemostasis time on outcome of partial pulpotomy in teeth with clinical signs indicative of irreversible pulpitis.Procedure or surgery
After caries removal and pulp exposure pulp tissue is amputated and pulpal wound will be irrigated with 3% NaOCl, and bleeding will be controlled by placing a cotton pellet soaked with 3% NaOCl over the pulpal wound for 2 to 3 minutes and will be repeated if required and time taken to achieve hemostasis will be recorded using stop watch. Teeth in which bleeding will be controlled within 6 mins will be placed in Group A, while those in which it gets controlled between 7 to 12 mins will be included in Group B. Root canal therapy will be initiated in cases in which haemostasis is not achieved even after 12 minutes. Followed by capping with 2-3mm layer of MTA. A layer of RMGIC will be placed over the MTA. Then the tooth will be permanently restored with composite resin.
| Study group | Role | What they receive |
|---|---|---|
| Hemostasis time upto 6 minutes | Active comparator | after partial pulpotomy, procedure pulp wound will be irrigated with 3% NaOCl, and bleeding will be controlled by placing a cotton pellet soaked with 3% NaOCl over the pulpal wound for 2 minutes and will be repeated if required and time taken to achieve hemostasis will be recorded using stop watch. Receives: Procedure: effect of hemostasis time on outcome of partial pulpotomy in teeth with clinical signs indicative of irreversible pulpitis. |
| hemostasis time 7 to 12 minutes | Experimental | after partial pulpotomy, procedure pulp wound will be irrigated with 3% NaOCl, and bleeding will be controlled by placing a cotton pellet soaked with 3% NaOCl over the pulpal wound for 2 minutes and will be repeated if required and time taken to achieve hemostasis will be recorded using stop watch.Root canal therapy will be initiated in cases in which haemostasis is not achieved even after 12 minutes. Receives: Procedure: effect of hemostasis time on outcome of partial pulpotomy in teeth with clinical signs indicative of irreversible pulpitis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
1.Clinical success rate
Clinical criteria of success:-
- No pain or discomfort except for the first few days after treatment.
- No tenderness to palpation or percussion and the tooth is functional.
- Normal mobility and probing pocket depth.
- Healthy soft tissues around teeth with no swelling, sinus tract.
Measured: baseline to 12 months
2.Radiographic success rate
Radiographic success criteria:-
- No pathosis such as root resorption, furcal pathosis or new periapical pathosis evident on the radiograph.
- Complete radiographic healing
Measured: baseline to 12 months
Secondary outcomes (2)
Post Operative Pain
To assess incidence and intensity of pain postoperatively at every 24 hours till 7 days using Visual analogue Scale of 0 to 100 millimeter line. Score 0 means no pain and Score100 means maximum pain. To assess incidence and intensity of pain postoperatively at every 24 hours till 7 days using Visual analogue Scale of 0 to 100 millimeter line. Score 0 means no pain and Score 100 means maximum pain
Measured: Baseline to 7 days]
OHRQoL assessment
OHIP-14 questionnare will be used to assess the quality of life.It consists of questionnaire in seven dimensions: functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap. It will be scored using a Lickert scale:
never=0; hardly ever=1; occasionally=2; fairly often=3; very often=4. Total score will be calculated ranging from 0-56, with higher score denoting the worst OHRQoL
Measured: baseline and at 24 hours, day 2, day 3, day4, day 5, day 6 and day 7 after the treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start1 Jun 2023
- Primary completion31 Jan 2025
- Study completion31 Jan 2025
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr. Pankaj Sangwan, MDS, Study director, PGIDS, Rohtak, Haryana 124001
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06768567
- Sponsor's protocol ID
- Vinita yadav
- Status last verified
- Jan 2025
- First submitted
- 3 Jan 2025
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Effect of Hemostasis Time on Partial Pulpotomy in Mature Permanent Teeth With Clinical Signs Indicative of Irreversible Pulpitis
- ClinicalTrials.gov ID
- NCT06768567
- Acronym / sponsor ID
- Vinita yadav
- Conditions
- Irreversible Pulpitis, Partial Pulpotomy
- Keywords
- partial pulpotomy, hemostatsis time
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 10 Jan 2025 (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 aim of this prospective study is to investigate the influence of time taken to achieve hemostasis on outcome of partial pulpotomy in teeth with clinical signs indicative of irreversible pulpitis.
OBJECTIVE:-
- To evaluate clinical and radiographic success of time taken to achieve hemostasis on outcome of partial pulpotomy in mature permanent teeth with clinical signs indicative of irreversible pulpitis.
- To evaluate OHRQoL and pain incidence \& severity after partial pulpotomy in teeth with clinical signs indicative of irreversible pulpitis.
Participants will of age group 18 to 45 years will be included and divided into two groups based on hemostasis time:
I(Intervention) - 6minutes C (Comparison) - 7-12 minutes
Detailed description
TITLE:- Evaluation of hemostasis time on partial pulpotomy in teeth with clinical signs indicative of irreversible pulpitis.
P (Population) - Mature permanent molars with clinical signs of irreversible pulpitis.
I (Intervention) - 6minutes C (Comparison) - 7-12 minutes O (Outcome) - Assessment of clinical and radiographic success at 12 months of follow up .
Assessment of OHRQoL at baseline, post-operatively every 24 hours for 1 week \& incidence and severity of pain at baseline and post-operatively every 24 hours till 1 week.
Time taken to achieve hemostasis has been suggested as a reliable surrogate measure to determine the depth of inflammation in the pulp. In absence of any other intraoperative indicator, it serves as a useful guide to the extent of pulp tissue removal required during pulpotomy. This trial will help formulate evidence based guideline regarding time for hemostasis advisable to achieve optimum success during pulpotomy in teeth with signs indicative of irreversible pulpitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hemostasis time upto 6 minutes | Active comparator | Procedure: effect of hemostasis time on outcome of partial pulpotomy in teeth with clinical signs indicative of irreversible pulpitis.after partial pulpotomy, procedure pulp wound will be irrigated with 3% NaOCl, and bleeding will be controlled by placing a cotton pellet soaked with 3% NaOCl over the pulpal wound for 2 minutes and will be repeated if required and time taken to achieve hemostasis will be recorded using stop watch. |
| hemostasis time 7 to 12 minutes | Experimental | Procedure: effect of hemostasis time on outcome of partial pulpotomy in teeth with clinical signs indicative of irreversible pulpitis.after partial pulpotomy, procedure pulp wound will be irrigated with 3% NaOCl, and bleeding will be controlled by placing a cotton pellet soaked with 3% NaOCl over the pulpal wound for 2 minutes and will be repeated if required and time taken to achieve hemostasis will be recorded using stop watch.Root canal therapy will be initiated in cases in which haemostasis is not achieved even after 12 minutes. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Mature permanent mandibular molars with carious pulp exposures and signs suggestive of irreversible pulpitis.
- vital pulp with demonstrable bleeding upon entry.
- The tooth is restorable.
- Tooth with mobility and probing depth within normal limits.
- Soft tissues around the tooth are normal with no swelling or sinus tract.
Key exclusion criteria (7 listed)
- patients who report history of antibiotic intake in past 1 month or analgesic intake in past 3 days.
- pregnant women.
- absence of opposing teeth
- 3rd molars
- medically compromised patients .
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 |
|---|---|---|
| effect of hemostasis time on outcome of partial pulpotomy in teeth with clinical signs indicative of irreversible pulpitis.After caries removal and pulp exposure pulp tissue is amputated and pulpal wound will be irrigated with 3% NaOCl, and bleeding will be controlled by placing a cotton pellet soaked with 3% NaOCl over the pulpal wound for 2 to 3 minutes and will be repeated if required and time taken to achieve hemostasis will be recorded using stop watch. Teeth in which bleeding will be controlled within 6 mins will be placed in Group A, while those in which it gets controlled between 7 to 12 mins will be included in Group B. Root canal therapy will be initiated in cases in which haemostasis is not achieved even after 12 minutes. Followed by capping with 2-3mm layer of MTA. A layer of RMGIC will be placed over the MTA. Then the tooth will be permanently restored with composite resin. | Procedure or surgery | Hemostasis time upto 6 minutes, hemostasis time 7 to 12 minutes |
Primary outcome
1.Clinical success rate
Time frame: baseline to 12 months
Clinical criteria of success:- 1. No pain or discomfort except for the first few days after treatment. 2. No tenderness to palpation or percussion and the tooth is functional. 3. Normal mobility and probing pocket depth. 4. Healthy soft tissues around teeth with no swelling, sinus tract.
2.Radiographic success rate
Time frame: baseline to 12 months
Radiographic success criteria:- 1. No pathosis such as root resorption, furcal pathosis or new periapical pathosis evident on the radiograph. 2. Complete radiographic healing
2 secondary outcomes
Post Operative Pain
Time frame: Baseline to 7 days]
OHRQoL assessment
Time frame: baseline and at 24 hours, day 2, day 3, day4, day 5, day 6 and day 7 after the 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 30 Apr 2025.
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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. Pankaj Sangwan, MDS study director
PGIDS, Rohtak, Haryana 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 effect of hemostasis time on outcome of partial pulpotomy in teeth with clinical signs indicative of irreversible pulpitis. in people with Irreversible Pulpitis and Partial Pulpotomy, 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 6 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: finished, as of the sponsor's last update on 30 Apr 2025. 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?
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?
1.Clinical success rate (time frame: baseline to 12 months). 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 30 Apr 2025.