METHOD: The Cochrane Central Register of Controlled Trials (1996 to Feb 2019) and MEDLINE (1966 to Feb 2019) were searched, including the related randomised control trials and reviewed articles to find unpublished trials or trials not obtained via electronic searches. Inclusion criteria for the studies included comparing recovery time, recording clinician satisfaction, and assessing the adverse effects of ketofol.
RESULTS: Eleven trials consisting of a total of 1274 patients met our criteria and were included in this meta-analysis. Five trials compared ketofol with a single agent, while six trials compared ketofol with combined agents. While comparing between ketofol and a single agent (either ketamine or propofol), ketofol showed significant effect on recovery time (MD: -9.88, 95% CI: - 14.30 to - 5.46; P = 0.0003; I2 = 92%). However, no significant difference was observed while comparing ketofol with combined agents (RR: 0.75, 95% CI: - 6.24 to 7.74; P < 0.001; I2 = 98%). During single-agent comparison, ketofol showed no significant differences in terms of clinician satisfaction (RR: 2.86, 95% CI: 0.64 to 12.69; P = 0.001; I2 = 90%), airway obstruction (RR: 0.72, 95% CI: 0.35 to 11.48; P = 0.81; I2 = 0%), apnoea (RR: 0.9, 95% CI: 0.33 to 2.44; P = 0.88; I2 = 0%), desaturation (RR: 1.11, 95% CI: 0.64 to 1.94; P = 0.28; I2 = 21%), nausea (RR: 0.52, 95% CI: 0.91 to 1.41; P = 0.2; I2 = 38%), and vomiting (RR: 0.63, 95% CI: 0.25 to 1.61; P = 0.18; I2 = 42%). During comparison with combined agents, ketofol was more effective in reducing hypotension (RR: 4.2, 95% CI: 0.2 to 0.85; P = 0.76; I2 = 0%), but no differences were observed in terms of bradycardia (RR: 0.70, 95% CI: 0.14 to 03.63; P = 0.09; I2 = 53%), desaturation (RR: 1.9, 95% CI: 0.15 to 23.6; P = 0.11; I2 = 61%), and respiratory depression (RR: 1.98, 95% CI: 0.18 to 21.94; P = 0.12; I2 = 59%).
CONCLUSION: There is low certainty of evidence that ketofol improves recovery time and moderate certainty of evidence that it reduces the frequency of hypotension. There was no significant difference in terms of other adverse effects when compared to other either single or combined agents.
TRIAL REGISTRATION: PROSPERO CRD42019127278 .
METHODOLOGY: This study was designed as a parallel, double blind, randomized controlled trial where symptomatic mature permanent teeth with carious pulp exposure meeting the inclusion criteria were randomly treated with full pulpotomy using one of 3 calcium silicate-based materials (ProRoot MTA, Biodentine and TotalFill). Full pulpotomy was performed, and haemostasis was achieved via a cotton pellet moistened with 2.5% NaOCl. A 3-mm layer of the calcium silicate-based material was randomly placed as the pulpotomy agent through a block randomization process followed by a resin-based composite restoration. Postoperative periapical radiograph was taken. Clinical and radiographic evaluation were completed after 6 months and 1 year. The patient and evaluator were blinded to the type of materials used. Pain levels were scored preoperatively and 7 days after treatment. Effect of potential prognosis factors including gender, age, diagnosis, bleeding time and type of caries were also analysed.
RESULTS: One hundred and sixty-four teeth in 146 patients received full pulpotomy and were randomly assigned to either the tested or control material through block randomization technique (50 MTA, 50 Biodentine and 64 TotalFill). The age ranged from 10 to 70 years. The diagnosis was irreversible pulpitis in 112 teeth (72%) and reversible pulpitis in 28 teeth (28%). The majority of patients presented with severe pain, during the first week 96.9% reported complete relief of pain or mild pain. Four cases had immediate failure. At 6 months the overall success rate was 92.2%, over 1 year 156/164 teeth attended follow-up with 12 failures (2 restorative failures and 10 endodontic failures), the overall success of pulpotomy at 1 year was 92.3% (144/156); 91.8% in MTA, 93.3% in Biodentine and 91.9% in TotalFill with no significant difference amongst the groups and no side effects observed. No significant association was evident between outcome and the investigated variables.
CONCLUSIONS: The 1-year success rate of full pulpotomy did not differ significantly between Biodentine pulpotomy, TotalFill pulpotomy, and MTA pulpotomy. The study was registered with clinical trials; registration number (NCT04345263).