Evaluation of Hemostasis Time on Partial Pulpotomy in Teeth With Clinical Signs Indicative of Irreversible Pulpitis
NCT ID: NCT06768567
Last Updated: 2025-04-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
132 participants
INTERVENTIONAL
2023-06-01
2025-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
OBJECTIVE:-
1. 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.
2. 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
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Partial Versus Miniature Pulpotomy in Teeth With Irreversible Pulpitis
NCT05406557
Comparative Evaluation of Partial and Complete Pulpotomy in Permanent Molars
NCT04397315
Outcome of Partial Pulpotomy in Moderate and Severe Pulpitis
NCT07123025
Outcome of Direct Pulp Capping and Partial Pulpotomy in Reversible Pulpitis
NCT07300124
COMPARATIVE EVALUATION OF DIRECT PULP CAPPING AND COMPLETE PULPOTOMY IN MATURE PERMANENT MANDIBULAR MOLARS WITH CLINICAL SIGNS INDICATIVE OF MODERATE PULPITIS
NCT06447753
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Hemostasis time upto 6 minutes
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.
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.
hemostasis time 7 to 12 minutes
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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)
Exclusion Criteria
* pregnant women.
* absence of opposing teeth
* 3rd molars
* medically compromised patients .
* Tenderness on percussion positive
* pathologic mobility
18 Years
45 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Postgraduate Institute of Dental Sciences Rohtak
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Dr. Pankaj Sangwan, MDS
Role: STUDY_DIRECTOR
PGIDS, Rohtak, Haryana 124001
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
PGIDS
Rohtak, Haryana, India
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Vinita yadav
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.