The aim of this randomised control trial is to compare the effect of wound lavage using 2.5% Ca(OCl)₂ and 2.5% NaOCl on the outcome of partial pulpotomy in mature permanent mandibular molars with symptomatic irreversible pulpitis (SIP).Primary objective is to evaluate and compare clinical and radiographic outcome of partial pulpotomy following use of 2.5% Ca(OCl)₂ and 2.5% NaOCl in mature permanent mandibular molars with symptomatic irreversible pulpitis.secondary objective is to evaluate OHRQoL and pain experience after use of 2.5% Ca(OCl)₂ and 2.5% NaOCl during partial pulpotomy in permanent mandibular molars with clinical signs indicative of symptomatic irreversible pulpitis.
patients aged 18-40 years
Mature permanent mandibular molars with extremely deep caries (caries penetrating the entire thickness of the dentine radiographically, without radiopaque zone separating lesion from the pulp) and clinical diagnosis of SIP with PAI score ≤ 2
Periodontally healthy teeth (probing pocket depth ≤3 mm and mobility within normal limit)
Patients having physical status of class 1 or 2 according to ASA classification
Non restorable teeth
No pulp exposure even after complete caries excavation
Necrotic or partially necrotic pulp upon exposure
Presence of sinus tract or soft tissue swelling
Parallel
Partial pulpotomy using calcium hypochlorite as wound lavage agent
Procedure/SurgeryFollowing pulp exposure and clinical assessment of pulp health through bleeding, the patient was randomly assigned to 2.5% Ca(OCl)₂ group.Patients who did not exhibit pulp exposure after complete caries removal, or those with partially necrotic pulp, were excluded from the study. The pulp wound was irrigated with 5 ml 2.5% Ca(OCl)₂ for 30 s. Haemostasis was achieved by placing the cotton pellets soaked with 2.5% Ca(OCl)₂ over the pulpal wound for 2 min. This process was repeated further if required, for a maximum of 10 min. Patients whose bleeding could not be arrested within 10 min had to undergo CP or pulpectomy. ProRoot MTA will be placed to a thickness of 2-3 mm gently over the pulpal tissue, a layer of RMGIC will be placed over the MTA.Then the tooth will be permanently restored with composite resin. After restoration, a postoperative periapical radiograph will be taken using a digital imaging system for comparative evaluation after 6 months and 12 months follow up.
Partial pulpotomy using sodium hypochlorite as wound lavage agent
Procedure/SurgeryFollowing pulp exposure and clinical assessment of pulp health through bleeding, the patient was randomly assigned to 2.5% NaOCl group.Patients who did not exhibit pulp exposure after complete caries removal, or those with partially necrotic pulp, were excluded from the study. The pulp wound was irrigated with 5 ml 2.5% NaOCl for 30 s. Haemostasis was achieved by placing the cotton pellets soaked with 2.5% NaOCl over the pulpal wound for 2 min. This process was repeated further if required, for a maximum of 10 min. Patients whose bleeding could not be arrested within 10 min had to undergo CP or pulpectomy. ProRoot MTA will be placed to a thickness of 2-3 mm gently over the pulpal tissue, a layer of RMGIC will be placed over the MTA.Then the tooth will be permanently restored with composite resin. After restoration, a postoperative periapical radiograph will be taken using a digital imaging system for comparative evaluation after 6 months and 12 months follow up.
Success rate at 12 months
Criteria 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.
Postoperative pain
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.
OHRQoL assessment
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
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