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Outcome of Direct Pulp Capping and Partial Pulpotomy in Reversible Pulpitis

Outcome of Direct Pulp Capping and Partial Pulpotomy in Reversible Pulpitis

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07300124
Enrollment
138
Registered
2025-12-23
Start date
2025-12-10
Completion date
2027-12-10
Last updated
2025-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Extremely Deep Caries, Reversible Pulpitis

Keywords

Partial Pulpotomy, Direct pulp capping

Brief summary

AIM: -The aim of the study is to compare the outcome of Direct Pulp Capping and Partial Pulpotomy in mature permanent teeth with Reversible Pulpitis OBJECTIVES: - Primary Objective: to compare the difference in clinical and radiographic outcome of direct pulp capping and partial pulpotomy in mature permanent teeth with Reversible Pulpitis. Secondary objective: To evaluate and compare postoperative pain after Direct Pulp Capping and Partial Pulpotomy in teeth with Reversible Pulpitis STUDY GROUPS: - Subjects of age group 15 to 40 years will be included and divided into two groups 1. Direct Pulp Capping in Permanent mature molars with Reversible Pulpitis 2. Partial Pulpotomy in Permanent mature molars with Reversible Pulpitis

Detailed description

TITLE: Outcome of Direct Pulp Capping and Partial Pulpotomy in Reversible Pulpitis It aims to answer does outcome of direct pulp capping and partial pulpotomy differ in mature permanent teeth with extremely deep caries with reversible pulpitis. P (Population) - Mature permanent mandibular molars with extremely deep caries and clinical signs of reversible pulpitis. I (Intervention) -Direct Pulp Capping in teeth with Reversible Pulpitis. C (Comparison) -Partial Pulpotomy in teeth with Reversible Pulpitis. O (Outcome) -Assessment of clinical & radiographic success at 6 and 12 months follow up -Assessment of pain experience at baseline, post-operatively every 24 hours for 1 week In extremely deep lesions, the dental pulp is often inflamed or at risk of microbial contamination, therefore requiring timely and precise intervention in order to preserve pulp vitality. In such cases, the removal of the superficial 2-3 mm of inflamed pulp tissue can help maintain the health of the remaining pulpal tissue. Duncan and other researchers have emphasized the importance of assessing both caries depth and pulpal status for deciding the effective treatment plan. Although numerous studies have investigated the outcomes of Direct Pulp Capping (DPC) and Partial Pulpotomy separately & have included cases based on caries depth & pulpal status, such as reversible pulpitis. However, there remains a notable lack of comparative clinical studies directly evaluating partial pulpotomy and direct pulp capping under standardized conditions involving extremely deep carious lesions with pulpal status as reversible pulpitis. Hence, this clinical trial aims to assess and compare the clinical and radiographic outcome of Direct Pulp Capping and Partial Pulpotomy in extremely deep caries with reversible pulpitis.

Interventions

PROCEDUREPartial Pulpotomy in Reversible Pulpitis

Procedure/Surgery: Outcome of Partial Pulpotomy in teeth with clinical signs indicative of Reversible Pulpitis with extremely deep caries. After caries removal and pulp exposure , 2-3 mm of pulp tissue will be amputated and the pulpal wound irrigated with 3% NaOCl. Bleeding will be controlled by placing a cotton pellet soaked in 3% NaOCl over the pulpal wound for 2-3 minutes, repeated if required. This will be followed by capping with a 2-3 mm layer of MTA in both the groups. A layer of RMGIC will then be placed over the MTA, and the tooth will be permanently restored with composite resin.

Outcome of direct pulp capping in teeth with clinical signs indicative of reversible pulpitis. After caries removal and pulp exposure 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. Followed by capping with MTA, a layer of RMGIC will be placed over the MTA. Then the tooth will be permanently restored with composite resin.

Sponsors

Postgraduate Institute of Dental Sciences Rohtak
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
15 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

1. Patients aged 15-40 years. 2. Mature permanent mandibular molars with extremely deep caries on radiograph, giving positive response to pulp sensibility test. 3. Pulpal bleeding can be controlled within 10 minutes 4. Patients having normal periapical status with periapical index (PAI) score ≤ 2 5. Periodontally healthy teeth 6. Positive response to pulp sensibility test

Exclusion criteria

1. Non restorable teeth 2. Negative response to vitality testing 3. Presence of sinus tract or soft tissue swelling 4. Absence of deep carious lesions radiographically 5. Radiographic signs of internal or external root resorption 6. Patient had moderate to severe pain, but preferred root canal treatment 7. Presence of sound dentin over pulp and pulp not exposed intraoperatively 8. Pulp haemorrhage could not be arrested within 10 minutes. 9. Necrotic pulp evident upon exposure 10. Pregnant women 11. Absence of antagonist teeth 12. Intake of antibiotics in last 30 days

Design outcomes

Primary

MeasureTime frameDescription
Success rate at 1 yearBaseline to 12 monthsCriteria for success:- Clinical: 1. Absence of signs and symptoms of spontaneous pain or pain on stimulus and 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. Absence of associated soft tissue swelling, sinus or fistula. Radiographic: - 1\. Absence of any periapical or interradicular radiolucency. 2. Complete radiographic healing (PAI score 1 or 2 acc. to Ostravik et al). 3. Absence of internal and external root resorption Tooth will be considered successful when all the above parameters are met.

Secondary

MeasureTime frameDescription
Postoperative PainBaseline and at 24 hours, Day 2, Day 3, Day 4, Day 5, Day 6 and Day 7 after the treatmentPost 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.

Countries

India

Contacts

Primary ContactDr. Pankaj Sangwan, MDS
drps_1@yahoo.co.in9996112202
Backup ContactDr. Prerna Yadav, PG student
viks0267@gmail.com9763276071

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026