PGIDS Rohtak
Rohtak, Haryana, 124001, India
Location status: Recruiting
Location contact
Dr. Pankaj Sangwan, MDS
CONTACT
Dr. Prerna Yadav, PG student
CONTACT
NCT Number: NCT07123025
The aim of the study is to compare the outcome of Partial Pulpotomy in mature permanent teeth with moderate and severe pulpitis.
OBJECTIVE: Primary objective- to compare the difference in clinical and radiographic outcome of partial pulpotomy in mature permanent teeth with moderate and severe Pulpitis. Secondary objective- To evaluate and compare OHRQoL and postoperative pain after Partial Pulpotomy in teeth with Moderate Pulpitis and Severe Pulpitis. Subjects of age group 15 to 40 years will be included and divided into two groups
1. Permanent mature molars with Moderate Pulpitis 2. Permanent mature molars with Severe Pulpitis
Interested in participating?
Request Info15 year–40 year
All sexes
Interventional
Not applicable
Rohtak, Haryana, 124001, India
Location status: Recruiting
Dr. Pankaj Sangwan, MDS
CONTACT
Dr. Prerna Yadav, PG student
CONTACT
TITLE- Outcome of Partial Pulpotomy in Moderate and Severe Pulpitis It aims to answer does outcome of partial pulpotomy differ in mature permanent teeth with moderate and severe pulpitis? P (Population) - Mature permanent mandibular molars with clinical signs of irreversible pulpitis. I (Intervention) -Partial Pulpotomy in teeth with Moderate Pulpitis. C (Comparison) -Partial Pulpotomy in teeth with Severe Pulpitis. O (Outcome) -Assessment of clinical & radiographic success at 6 and 12 months follow up
-Assessment of OHRQoL & pain experience at baseline, post-operatively every 24 hours for 1 week Various studies showed partial pulpotomy is successful in managing cases of irreversible pulpitis. The word irreversible presents a problem as at least part of the pulp can be saved. As a result, Wolter's proposed a classification system based on severity of symptoms. However, the treatment modalities proposed under the classification system need to validated by further research. To the best of our knowledge, Careddu & Duncan remains the only study that has explored the success of partial pulpotomy in terms of Wolter's classification but had low numbers and uneven distribution of moderate and severe pulpitis cases. No other clinical trials were found that compared the outcomes of partial pulpotomy in cases of moderate and severe pulpitis, where ambiguity still exists regarding the best treatment modality. This study trial aims to compare the difference in clinical and radiographic outcome of partial pulpotomy in mature permanent teeth with moderate and severe pulpitis.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
For Severe Pulpitis- Severe spontaneous pain and clear pain reaction to warmth and cold stimuli, often, sharp to dull throbbing pain, patients have trouble sleeping because of the pain (gets worse when lying down). Tooth is very sensitive to touch and percussion.
Exclusion criteria
Procedure/Surgery: Outcome of partial pulpotomy in teeth with clinical signs indicative of Moderate 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. Root canal therapy will be initiated in cases in which haemostasis is not achieved even after 10 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.
Description: Procedure/Surgery: Outcome of partial pulpotomy in teeth with clinical signs indicative of Severe 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. Root canal therapy will be initiated in cases in which haemostasis is not achieved even after 10 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
Time frame: Baseline to 12 months
Criteria for success:-
Clinical:
Time frame: Baseline and at 24 hours, Day 2, Day 3, Day 4, Day 5, Day 6 and Day 7 after the treatment
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.
Time frame: Baseline and at 24 hours, Day 2, Day 3, Day 4, Day 5, Day 6 and Day 7 after the treatment
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
Contact information is provided by the study sponsor or research team.
Dr. Pankaj Sangwan, MDS
CONTACT
Dr. Prerna Yadav, PG student
CONTACT
Postgraduate Institute of Dental Sciences Rohtak
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07242742
Dental Pulp Diseases, Extremely Deep Caries
Singapore
View Trial DetailsNCT07696702
Deep Caries, Extremely Deep Caries
Rohtak, Haryana, India
View Trial DetailsNCT07638254
Dental Pulp Diseases, Pulpitis
San Luis Potosí City, San Luis Potosí, Mexico
View Trial DetailsNCT07578662
Extremely Deep Caries, Reversible Pulpitis
Rohtak, Haryana, India
View Trial Details