An interventional study of Direct pulp capping and Complete Pulpotomy in Moderate Pulpitis, sponsored by Postgraduate Institute of Dental Sciences Rohtak. Status unknown at 1 site in India. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-07.
Sponsored by Postgraduate Institute of Dental Sciences Rohtak · Not applicable, Interventional, and Treatment
Title: Comparative evaluation of direct pulp capping and complete pulpotomy in mature permanent mandibular molars with clinical signs indicative of moderate pulpitis: Randomized Clinical Trial
Rationale: According to new Wolters pulpal clinical classification, Moderate pulpitis exhibit symptoms of prolonged reaction to cold, which can last for minutes, possibly percussion sensitive and spontaneous dull pain which are correspond to irreversible pulpitis.
Complete/partial pulpotomy are suggested to be the choice of treatment for such cases. It has been suggested that infection is often the cause of inflammation, an inflamed pulp should be able to heal if the source of infection is eliminated as in other body organs. Removal of trigger (i.e. caries) followed by application of biocompatible material which makes a good seal in a sterile environment has potential to allow for recovery and healing of the inflamed pulp tissue which is thought to be beyond recovery. Based on this premise, DPC can be considered as minimally invasive approach for the management of teeth with inflamed pulps in place of the conventional approach of partial/complete pulpotomy in adults
Research Question Does Direct Pulp Capping have comparable outcome with complete pulpotomy in mature permanent teeth with clinical signs indicative of moderate pulpitis?
Rationale: Vital pulp therapy has been traditionally recommended only in teeth with reversible pulpitis with no periapical pathologies or in teeth with either mechanical pulp exposure or recent traumatic exposure. Clinical symptoms such as characteristic, severity and intensity of pre-operative pain do not accurately talk about the status of the pulp inflammation and the depth of involvement. It has been demonstrated that there is no precise correlation between clinical symptoms and the histopathological status of the pulp, mainly in case of irreversible pulpitis, that might lead to a wrong diagnosis. Vitality tests such as cold test or electric pulp tests reveal only whether the pulp is responsive to respective stimuli or not. According to new Wolters pulpal clinical classification, Moderate pulpitis exhibit symptoms of prolonged reaction to cold, which can last for minutes, possibly percussion sensitive and spontaneous dull pain which are correspond to irreversible pulpitis.
Complete/partial pulpotomy are suggested to be the choice of treatment for such cases. It has been suggested that infection is often the cause of inflammation, an inflamed pulp should be able to heal if the source of infection is eliminated as in other body organs. Removal of trigger (i.e. caries) followed by application of biocompatible material which makes a good seal in a sterile environment has potential to allow for recovery and healing of the inflamed pulp tissue which is thought to be beyond recovery. Based on this premise, DPC can be considered as minimally invasive approach for the management of teeth with inflamed pulps in place of the conventional approach of partial/complete pulpotomy in adults
Aim: To compare the outcome of direct pulp capping and complete pulpotomy in mature mandibular permanent molars with clinical signs indicative of moderate pulpitis.
Objectives:
P (Population) - Mature Permanent Mandibular molars with clinical signs of moderate pulpitis I (Intervention) -Direct pulp capping C (Comparison) - Complete pulpotomy O (Outcome) - Assessment of clinical and radiographic success at 12 months follow up.
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1. The patient should be ≥18 years of age. 2. Restorable mature permanent 1 st and 2nd Mandibular molars with extremely deep caries (≥2/3 dentine involvement) 3. Tooth should give positive response to pulp sensibility testing. 4. Clinical diagnosis of moderate pulpitis. 5. Radiographic finding of periapical index (PAI) score ≤2. 6. Healthy periodontium (probing pocket depth ≤3 mm and mobility within normal limit).
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Exclusion Criteria:
Procedure: Direct pulp capping
Procedure: Complete Pulpotomy
after caries excavation, the pulp will be inspected visually. If bleeding present, sterile cotton soaked in 3% NaOCl will be placed over the pulpal wound for 2 minutes, repeated for up to 6 min if required. Cases in which bleeding will not stop within 6 minutes will be excluded from the study and further managed by RCT. The exposed pulp will be capped with MTA which will be freshly mixed according to manufacturer's instructions and placed in thickness of 2 to 3 mm over the pulp exposure site using an amalgam carrier following which the cavity floor will be dabbed with moist sterile cotton pellet to ensure the setting of MTA, followed by application of a layer of light-cure RMGIC over MTA and light-curing for 20s. Then tooth will be restored using composite resin following etch and rinse technique.
exposed pulp tissue will be amputated using fresh sterile large round diamond bur in a high-speed hand-piece under water coolant 28to the level of canal orifices. The pulp wound will be irrigated with 3% NaOCl. For hemostasis, sterile cotton soaked in 3% NaOCl will be placed over the pulpal wound for 2 minutes, repeated for up to 6 min if required. Root canal therapy will be initiated in cases in which haemostasis is not achieved within 6 minutes. After hemostasis, ProRoot MTA will be placed in thickness of 2 to 3 mm over the pulp exposure site using an amalgam carrier. After placement, the cavity floor will be dabbed with moist sterile cotton pellet to ensure the setting of MTA, followed by application of a layer of light-cure RMGIC over MTA and light-curing for 20s. The tooth then will be restored using composite resin following etch and rinse technique.
Clinical and radiographic success
Clinical success criteria No history of spontaneous pain or discomfort except for the initial days after treatment. No tenderness to palpation or percussion and the tooth is functional. Normal mobility and probing pocket depth. Soft tissues around tooth are normal with no swelling or sinus tract. Radiographic success criteria No pathosis evident on the radiograph such as root resorption, furcal pathosis or new periapical pathosis. Periapical Index score 1 or 2 according to Orstavic6 et al.
Time frame: 12 months
Pain incidence and reduction
Patients will be informed that they may experience pain in the days after treatment and will be instructed to record their pain at 24 h, 2, 3, 4, 5, 6 and 7 days after the treatment, to be submitted after 1 week. They will be instructed to use analgesics (Ibuprofen 400 mg every 6-8 h), if needed for pain relief. They will be requested to note down the details of analgesic intake on the pain form regarding the number of doses required, timing of the dose and whether it provided adequate pain relief or not (yes/no). 29 Visual analogue scale (VAS) from 0 to 100 will be used to record preoperative and post -operative pain.
Time frame: 7 days
Started Jun 2023 (actual). Primary completion is estimated for Nov 2024, 17 months after the start.
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