Influence of Proximal Caries on Outcome of Direct Pulp Capping in Permanent Mandibular Molars With Reversible Pulpitis

Official title

Influence of Proximal Caries on Outcome of Direct Pulp Capping in Permanent Mandibular Molars With Reversible Pulpitis: A Prospective Study

Overview

The aim of the study is to assess the Influence of proximal caries on outcome of direct pulp capping in permanent mandibular molars with sign of reversible pulpitis. objective- Primary objective- To evaluate and compare the clinical and radiographic outcome of Direct pulp capping in mandibular molars with occlusal and proximal carious lesions. Secondary objective- To evaluate and compare 1.OHRQoL after Direct pulp capping in occlusal and proximal lesion. 2. Postoperative pain, after Direct pulp capping in occlusal and proximal lesion Subjects of age group 15 - 40 yrs will be included and divided into two groups 1) Permanent mature molars with proximal carious lesion 2)Permanent mature molars with occlusal carious lesion.

Detailed description

Title- Influence of proximal caries on outcome of direct pulp capping in permanent mandibular molars with reversible pulpitis PICO P (Population) - Mature permanent mandibular molars with extremely deep caries and signs of reversible pulpitis.I (Intervention) - Direct Pulp Capping in Proximal carious lesion. C (Comparison) - Direct Pulp Capping in Occlusal 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.

2\. Assessment of OHRQoL pain experience at baseline, postoperatively every 24 hours for 1 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 AAE, DPC should be performed only in mechanically exposed pulp. According to the position statement of European society of endodontology, however, if the teeth is vital and there is no sign of irreversible pulpitis, but has an extremely deep carious lesion with unavoidable pulp exposure, DPC can be the treatment of choice.According to bogen et al, DPC shows excellent success rate of 97.96% with MTA as capping agent material. In 2013, Cho et al, evaluated the outcome of direct pulp capping in cariously exposed pulp and the prognostic factors affecting the outcome. They found age and site of exposure to have a significant effect on the outcome of DPC.Site of exposure has always been the controversial topic, some studies show it has significant effect, some shows non- significant effect on outcome of DPC. As compare to occlusal lesion, in proximal lesion complete caries removal, application of pulp capping material and sealing of the cavity is difficult. Also, isolation is the key problem in proximal area which is difficult to obtain. All these factors have been suggested to make the outcome of proximal exposure more unfavorable than occlusal exposure with respect to prognosis of pulp capping. According to Cho et al, site of exposure shows significant effect on DPC and there is better survival rate on occlusal site \[OR = 1\] as compared to axial site \[OR =3.9(1.3-15.8)\]. Various studies have statistically assessed the site of exposure as secondary demographic variable affecting the outcome of DPC, there is no study till now which has directly, systematically compared the influence of occlusal and proximal lesion on the direct pulp capping.

Thus, the aim of the present study is to assess the influence of the proximal lesion on the outcome of direct pulp capping based on clinical and radiographical findings.

Interventions

• Procedure Direct pulp capping in proximal carious lesion
  After pulp exposure, pulp wound will be irrgated 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 6 mints. Hemostasis will be achieved with 3% NaOCl for upto 6 mins if required. The time used to control bleeding will be recorded for each tooth. Teeth with excessive uncontrollable bleeding even after 5 mins will be excluded from the study; however, definite treatment will be provided to the patient. Size of
• Procedure Direct pulp capping in occlusal carious lesion
  After pulp exposure, pulp wound will be irrgated 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 6 mints. Hemostasis will be achieved with 3% NaOCl for upto 6 mins if required. The time used to control bleeding will be recorded for each tooth. Teeth with excessive uncontrollable bleeding even after 5 mins will be excluded from the study; however, definite treatment will be provided to the patient. Size of

Primary outcome measures

• Success rate at 12 months [Time frame: 18 months]

Secondary outcome measures (2)

• 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]
• OHRQoL assessment [Time frame: Baseline and at 24 hours, Day1,Day 2, Day 3, Day 4, Day 5, Day 6 and Day 7 after the treatment]

Eligibility criteria

Inclusion criteria

• Mature permanent mandibular molars with extremely deep caries that penetrate the entire thickness of dentine as detected on radiograph with reversible pulpitis will be included.
• Participant with 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 the removal of the stimulus, with no significant radiographic changes in the periapical region of the suspect tooth and the pain experienced is not spontaneous.
• The pulpal sensibility will be confirmed through positive response to electric and cold tests (Endo frost) and the presence of bleeding after caries excavation. 4.Pulpal and the periapical diagnosis will be established based on the diagnostic terminology approved by American Association of Endodontists (AAE, 2019).

5.Teeth with a negative response to palpation and percussion testing and radiographic finding of periapical index (PAI) score ≤2 and healthy periodontium (probing pocket depth ≤3 mm and mobility within normal limit) will be included. 6.Teeth in which hemostasis achieved within 5 mins will be included.

7.Only pulp exposures with size 0.5-1 mm will be included

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Exclusion criteria

• Mechanical or pulp exposure due to trauma
• absence of exposure after excavation of caries
• failure to achieve hemostasis within 5 mins
• irreversible pulpitis and teeth having periapical lesions
• periodontal disease, resorptive defects, calcified canals, as assessed by radiographic examination will serve as criteria for exclusion.
• Also immunocompromised, Pregnant and subjects having systemic diseases will be excluded -

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, Haryana 124001 — Rohtak

Identifiers

NCT: NCT07578662 · Aditi Diwan

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗