Comparative Evaluation of Direct Pulp Capping Between Deep and Extremely Deep Caries in Mature Permanent Mandibular Molars .
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- What is being studied
- The protocol lists: Direct pulp capping in extremely deep carious lesion., Direct pulp capping in deep carious lesion..
- Who it may be relevant to
- Registry conditions: Reversible Pulpitis, Deep Caries, Extremely Deep Caries. Basic parameters: 18 years — 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- India
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparative Evaluation of Direct Pulp Capping Between Deep and Extremely Deep Caries in Mature Permanent Mandibular Molars With Reversible Pulpitis: A Prospective Study
Overview
The aim of the study is to compare the clinical and radiographic outcomes of direct pulp capping for deep and extremely deep caries in mature permanent mandibular molars with reversible pulpitis. Primary objective of the study is to evaluate the clinical and radiographic success of direct pulp capping for deep and extremely deep caries in mature permanent mandibular molars with reversible pulpitis. Secondary objective of the study is to evaluate and compare postoperative pain following direct pulp capping for deep and extremely deep caries in mature permanent mandibular molars with reversible pulpitis. Subjects of age group 18 - 40 yrs will be included and divided into two groups 1) Permanent mature molars with deep carious lesion 2) Permanent mature molars with extremely deep carious lesion.
Detailed description
TITLE-Comparative evaluation of direct pulp capping between deep and extremely deep caries in mature permanent mandibular molars with reversible pulpitis. PICO P (Population) -Mature permanent mandibular molars with clinical signs of reversible pulpitis. I (Intervention) - Direct pulp capping in teeth with extremely deep carious lesion. C (Comparison) - Direct pulp capping in teeth with deep carious lesion. O (Outcome) - 1. Assessment of clinical success at 7 days, 6 months, 12 months and radiographic success at 6 and 12 months of follow up. To assess pain experience at preoperative and post operatively at 24 hours intervals for one week. Direct pulp capping is considered as the most conservative procedure to treat mechanically or traumatically exposed pulp. In this procedure, biomaterial is directly applied on the exposed pulp. According to depth of caries, carious lesion has been classified as deep caries (reaching inner quarter of dentine) and extremely deep caries (extending through entire dentine thickness). Various studies on direct pulp capping in deep carious lesions with reversible pulpitis have reported success rates ranging from 77.3% to 100%. A prospective study by demonstrated a 95.2% success rate for direct pulp capping with extremely deep carious lesions and reversible pulpitis in young individuals. A randomized clinical trial , which included both deep and extremely deep carious lesions, reported a direct pulp capping success rate of 81.3%. A recent systematic review and meta-analysis highlighted that the depth of caries penetration is a critical factor that need to be considered when evaluating the outcomes of direct pulp capping in cariously exposed pulps. Currently, there is a lack of clinical trials comparing the effectiveness of direct pulp capping in cases of deep and extremely deep caries presenting with reversible pulpitis. Hence, the present trial is designed to assess differences in clinical and radiographic outcomes of direct pulp capping between deep and extremely deep carious lesions in mature permanent teeth diagnosed with reversible pulpitis.
Interventions
- Procedure Direct pulp capping in extremely deep carious lesion.
After pulp exposure, 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 every 2 minutes till. Hemostasis will be achieved with 3% NaOCl .The time used to control bleeding will be recorded for each tooth. Teeth with excessive uncontrollable bleeding even after 8 mins will be excluded from the study; however, definite treatment will be provided to the patient. Size of exposure will be measured. After t - Procedure Direct pulp capping in deep carious lesion.
After pulp exposure, 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 every 2 minutes. Hemostasis will be achieved with 3% NaOCl . The time used to control bleeding will be recorded for each tooth. Teeth with excessive uncontrollable bleeding even after 8 mins will be excluded from the study; however, definite treatment will be provided to the patient. Size of exposure will be measured. After that,
Primary outcome measures
- Success rate at 12 months [Time frame: 12 months]
Secondary outcome measures (1)
- Postoperative pain [Time frame: Baseline and at 24 hours, Day 1, Day 2, Day 3, Day 4, Day 5, Day 6 and Day 7 after the treatment]
Eligibility criteria
Inclusion criteria
- The patient should be 18-40 years of age.
- Patients with deep and extremely deep caries in permanent mandibular molars.
- Deep caries lesion -Reaching the inner quarter of dentine on radiograph
- Extremely deep caries lesion - Caries penetrating the entire thickness of dentin on radiograph.
- Reversible pulpitis will be diagnosed clinically based on discomfort experienced by the participant when a stimulus such as cold or sweet is applied and goes away within a couple of seconds following removal of stimulus, with no significant radiographic changes in the periapical region of the suspect tooth and pain experienced is not spontaneous.
- Tooth should give positive response to pulp sensibility testing.
- Bleeding can be controlled with in 8 minutes.
- Radiographic finding of periapical index (PAI) score ≤2.
- Healthy periodontium (probing pocket depth ≤3 mm and mobility within normal limit).
Exclusion criteria
- Teeth with immature roots.
- Internal/external resorption.
- Patient experience spontaneous pain.
- Negative response to vitality testing
- No pulp exposure after complete caries excavation.
- Signs of pulpal necrosis, insufficient bleeding after pulp exposure, sinus tract, swelling.
- Bleeding could not be controlled in 8 minutes.
- Pregnant women
- Contributory medical history (alcoholism, smokers, diabetic, hypertension, drug dependency, Heart or valve disease, hepatitis, herpes, immunodeficiency diseases , infectious diseases, kidney or liver, migraine)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
India · 1 center
- PGIDS , Rohtak — Rohtak
Identifiers
NCT: NCT07696702 · Vineeta